IQVIA Connected Devices Investigators Manual Easy on-PC Spirometry - Gates-MRI-TBD06-201 - Version 01 - 23rd June 20231

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IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry
IQVIA Connected Devices Investigators Manual

Easy on-PC Spirometry – CDDP ClinSpark
Protocol: Gates-MRI-TBD06-201
Version # Effective Date Document Author
Version 01 23rd June 2023 Initial Document
Gates-MRI-TBD06-201, Investigators Manual Version 01, 23rd June 2023 Reference: CS_OP_CND0010
Template No.: CN_TP_CND0155 Revision 1
Effective Date: 28April2023

Copyright © 2023 IQVIA. All rights reserved. The contents of this document are confidential and proprietary to IQVIA Holdings Inc. and
its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited.
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Table Of Contents
1. Introduction ...................................................................................................................... 5
2. List of abbreviations and definition of terms ................................................................. 6
3. Site staff training .............................................................................................................. 7
4. Training resources ........................................................................................................... 7
5. Receipt of equipment ....................................................................................................... 8
5.1 GENERAL SYSTEM DESCRIPTION ............................................................................................................................. 9

5.2 EQUIPMENT REPLACEMENT AND / SUPPLY RE-ORDER................................................................................................. 9
6. Cleaning & hygiene instructions ................................................................................... 10
6.1 LIST OF CLEANING SOLUTION ............................................................................................................................ 10

6.2 INSTRUCTIONS TO REDUCE CROSS CONTAMINATION.............................................................................................. 11
7. Purpose ........................................................................................................................... 12
8. Login to CDDP ClinSpark portal .................................................................................... 13
9. Technician certification process/Proficiency testing for technicians ........................ 15
9.1 ENROLLMENT FOR PROFICIENCY TESTING/CERTIFICATION ...................................................................................... 16

9.2 REQUIRED MATERIALS FOR PERFORMING CALIBRATION CHECK ................................................................................ 18
9.3 MULTIFLOW CALIBRATION CHECK/VERIFICATION FOR PROFICIENCY TEST .................................................................. 19
9.4 REPEAT CALIBRATION CHECK ........................................................................................................................... 24
9.5 PERFORM TRIAL FOR PROFICIENCY TEST .............................................................................................................. 26
10. Enrollment for spirometry test in CDDP ClinSpark portal ........................................... 33
11. Search the already enrolled subject on CDDP ClinSpark portal ................................. 34
12. Race mapping ................................................................................................................. 39
13. Prepare for the test......................................................................................................... 40
13.1 SUBJECT COACHING....................................................................................................................................... 41

13.2 ACCEPTABILITY CRITERIA AND REPEATABILITY CRITERIA. ........................................................................................ 42
13.3 CONTRAINDICATIONS .................................................................................................................................... 43
14. Multi-flow calibration check/verification for spirometry test ....................................... 44

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14.1 Required materials for calibration verification .............................................................. 49

14.2 Calibration verification Process ........................................................................................ 50
14.3 Error message for wrong device used for calibration verification .......................... 53
14.4 Repeat calibration check .................................................................................................... 53
15. Perform Trial for Spirometry Test ................................................................................. 56
15.1 Collect visit form without doing Calibration................................................................... 65

15.2 Add trial in EasyOne Connect ............................................................................................ 67
16. Import results into CDDP ClinSpark portal ................................................................... 70
16.1 Audit trial before overreading ............................................................................................ 74

16.2 Adding Additional trials to a current test ........................................................................ 76
16.3 Unscheduled visit .................................................................................................................. 82
16.4 Repeat visit ............................................................................................................................. 84
17. IQVIA Overreader quality review ................................................................................... 88
18. Report after overreading ................................................................................................ 88
18.1 Audit trial after overreading ................................................................................................ 93

19. Workflow for principal investigator ............................................................................... 95
20. Responding to a query and associated detail .............................................................. 98
20.1 HOW TO IDENTIFY AND RESOLVE OUTSTANDING QUERIES ...................................................................................... 98

20.2 HOW TO EXPORT THE QUERY LISTING .............................................................................................................. 103
21. Dashboard .................................................................................................................... 104
21.1 Spirometry Value Trend Graph ........................................................................................ 104

21.2 Quality Metrics Dashboard .............................................................................................. 106
22. Reports for subjects enrolled on site.......................................................................... 114
22.1 Study subject report ........................................................................................................... 114

22.2 Clinical data report .............................................................................................................. 115
23. Site responsibilities at close out ................................................................................. 116
24. Project contact information ......................................................................................... 117
25. Internet Outage ............................................................................................................. 118
26. General troubleshooting .............................................................................................. 124
27. Appendix ...................................................................................................................... 130
APPENDIX A: INITIAL LOGIN AND PASSWORD RESET..................................................................................................... 130


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APPENDIX B: SITE TRAINING FORM TO BE ADDED BY PM ............................................................................................. 134

APPENDIX C: EQUIPMENT RECEIPT CHECKLIST ........................................................................................................... 135
APPENDIX D: CONSENT FORM ................................................................................................................................ 136
APPENDIX E: PROFICIENCY REPORT.......................................................................................................................... 137
APPENDIX F: QUALITY GRADE................................................................................................................................. 138
APPENDIX G: STUDY ACTIVITY PLAN ........................................................................................................................ 139

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1. Introduction
IQVIA Connected Devices (IQVIA CD) provides centralized Spirometry services for
pharmaceutical clinical studies. This Investigator Manual (IM) will provide the
standardized instructions for the use of Easy on-PC Spirometry device and the
processes followed at IQVIA CD to conduct a respiratory study in which spirometry
services will be used. The Investigator and the site’s study team are requested to review
the manual prior to enrolling the first study subject and starting an Easy on-PC session.
As a part of the Gates-MRI-TBD06-201 trial, IQVIA Connected Devices will

provide the following services:
➢ Easy on-PC Spirometry device with all accessories (for spirometry only)
➢ A NDD Medical Technologies provisioned laptop preconfigured for site
➢ Toll-free phone numbers with 24 x 7 multilingual contact center support
➢ Replenishment of accessories and consumables during the study
➢ Replacement of any faulty device and/or laptop
➢ Instruction Manual for the site Investigator for Spirometry conduct on the study
➢ Login instruction for the IQVIA provided laptop and the IQVIA CDDP ClinSpark
portal
➢ Perform Overread services on Spirometry tests

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2. List of abbreviations and definition of terms
Abbreviation Explanation
ATPS Ambient temperature pressure saturated
ATS American Thoracic Society

Body temperature pressure saturated—refers to converted
BTPS
environment conditions, can be converted from ATPS
ERS European Respiratory Society
Electromagnetic compatibility
EMC
The Forced expiratory volume
FEV1
Forced vital capacity
FVC
Gerate-Daten-Transfer - German electronic medical record
GDT
standard
Global Initiative for Chronic Obstructive Lung Disease
GOLD
Global Lung Function Initiative
GLI
Hospital information system
HIS
Health Level 7—international EMR standard
HL7
Lower limit of normal
LLN
National Institute for Occupational Safety and Health
NIOSH
National Lung Health Education Program
NLHEP
Standard deviation
SD
Standard error of the estimate
SEE
Total lung capacity
TLC
Connected Device
CD

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3. Site staff training
• IQVIA CD will train the sites on the Easy on-PC Spirometry device usage and
procedures in CDDP ClinSpark portal for study activities like subject enrollment, query
resolution and data visualization.
• It is the responsibility of the investigator/designee to ensure the site staff conducting

the study are trained/certified on Easy on-PC Spirometry device before performing any
trial activities on the IQVIA CDDP ClinSpark portal.
• IQVIA CD recommends that all site trainings are documented per the site/study
guidelines (Refer to Appendix B). IQVIA CD does not track site training. This is
responsibility of the Site Investigator and/or designee.
• Before any technician can perform tests on study subjects, they must pass the
certification process. (Refer Section 9 ) of this manual for more details) This is
extremely important to ensure that high quality and acceptable spirometry data
can be attained for the trial.
4. Training resources
• Virtual Training / recording of training session
• IQVIA CD provided Investigator Manual for Easy on-PC Spirometry device.
• IQVIA CD ClinSpark Help content inside CDDP ClinSpark portal
• Find the below picture for IQVIA ClinSpark Help content inside CDDP ClinSpark
portal

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5. Receipt of equipment
• Upon receipt of the equipment at the site, the equipment checklist document
provided (Appendix C) must be checked and completed. Additionally, the serial
numbers must be filled in and the checklist document must be signed.
• The signed checklist document will be filed in the Investigator Site File (ISF) and a
copy to be emailed to your assigned CRA as confirmation of receipt of all equipment
and that it is in good condition.
• By signing the equipment checklist, you agree to receipt of all equipment and that
they are in good condition. If you have any problem or any questions, please call the
contact center so that it may be addressed.
Important:
Please keep all packaging for proper returning of the equipment after the duration of
the study.
• It is important to read and understand the IQVIA CD Investigator Easy on-PC
Spirometry manual before attempting to use the devices and before accessing the
IQVIA CDDP ClinSpark portal. If you’re having any issue with the CDDP ClinSpark
portal, reach out to the contact center at the address below. (Reach out to the contact
center on the country specific toll-free number).
• Please complete the important procedures detailed below soon after you receive
the Easy on-PC device and prior to recording your first subject spirometry data and
proficiency testing too.
Please contact CSSCDSupport@quintiles.com for any assistance
The site will receive the following devices/supplies as a part of the startup kit:
➢ Provisioned laptop pre-configured with NDD EasyOne Connect software and

CDDP ClinSpark Agent
➢ Charging adaptor for laptop
➢ The Easy on-PC spirometer sensor
➢ Nose Clips
➢ Spirette respiratory tubes
➢ NDD Inline Filters
➢ Thermohygrometer

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➢ Calibration Kit (3L Calibration Syringe, NDD Spirette Cal Check Adapter)
➢ Consent Form
Points to remember:
• Site to ensure that the computer systems are adequately protected from
unauthorized access, compromise, or disclosure.
• Use the trial provisioned laptops only for carrying out work associated with the
concerned sponsor’s study.
• Never share passwords with anyone.
• Abide by all regulatory/applicable laws related to clinical trial data privacy,
confidentiality guidelines and good computing practices while using the trial
provisioned laptop.
5.1 General system description

• This equipment must only be used for the indicated clinical trial and is not available
for use for any other purpose. Equipment is tested and verified prior to being issued by
NDD. The equipment remains the property of IQVIA CD.
5.2 Equipment replacement and / supply re-order

• Please contact the IQVIA CD helpdesk team for any necessary equipment
replacement or supply re-orders. Please consider a turnaround of at least 2 weeks for
the additional supplies to be shipped.

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6. Cleaning & hygiene instructions

• Always wear disposable gloves while cleaning the spirometer between subjects,
clean the Easy on-PC sensor, and disinfect your hands. Make sure that no fluid
penetrates the Easy on-PC sensor while cleaning. It is important to not immerse the
handheld sensor in any fluid while cleaning.
• To clean the Easy on-PC sensor and to disinfect your hands after each subject, do
the following:
➢ Use a soft cloth with a cleaning solution, the list of cleaning solutions (Refer
6.1) and wipe the Easy on-PC sensor and ensure that the cleaning solution
does not enter inside the spirometer.
➢ Take off the disposable gloves and disinfect your hands before you put on new
disposable gloves.
➢ We should ask the sites to use plastic cover/guard for the keyboard.
6.1 List of cleaning solution
To clean the Easy on-PC sensor from environmental dirt, you can use a damp cloth.
Disconnect the power source. Remove cables and lead wires from device before
cleaning. After each subject, clean the Easy on-PC sensor.
➢ For general cleaning of cables and lead wires, use a soft, lint-free cloth lightly
moistened with a mild soap and water solution. Wipe and air dry.
➢ You can use a soft cloth with a cleaning solution according to the following list:
o 70 percent isopropyl alcohol solutions

o Solutions that contain formaldehyde
o Solutions that contain chlorine

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➢ For disinfecting the exterior surfaces of the device, patient acquisition module,
cables, and lead wires, wipe exterior using:
• Clorox Healthcare® Bleach Germicidal Wipes (use according to
instructions on product label), or
• A soft, lint-free cloth with a solution of Sodium Hypochlorite (10%
household bleach and water solution) minimum 1:500 dilution (minimum
100 ppm free chlorine) and maximum 1:10 dilution as recommended by the
APIC Guidelines for Selection and Use of Disinfectants
6.2 Instructions to reduce cross contamination
• Infection can be transmitted by direct contact with surfaces such as mouthpieces,

nose clips, handheld spirometers, chair arms. Indirect transmission occurs by aerosol
droplets generated by the subject blowing into the equipment, but also expelled into the
air of the testing room between maneuvers.
• Preferably, spirometry tests should be performed in well ventilated room.
• Technicians must wash their hands with soap or use a hand sanitizer before contact
with each new study participant. Upon first entry into the spirometry lab, study
participants should be asked to wash their hands with soap or use a hand sanitizer,
because participants will be holding the spirometer and touching various surfaces.
Technician should wear a mask while performing a spirometry test.
• To reduce immediate risk from coughing, it is highly recommended that patients are
pre-counselled about what actions to take if they need to cough. Firstly, they should try
to stay on the mouthpiece / testing device if possible and cough in to the bacterial/viral
filter. If they feel they need to come off the device to cough, they should have a surgical
facemask/ handkerchief in immediate proximity that is placed over the mouth
immediately following completion of the maneuver (e.g., simple surgical mask is lowered
to the chin to allow a mouthpiece to be used and then replaced at end of procedure.
• All disposable items, including spirettes (mouthpiece), filters, nose clips etc. must be
disposed of at the end of the testing session. Gloves should be worn when handling
potentially contaminated equipment and/or if the technician/s have any open cuts or
sores their hands. External surface of the spirometer should be cleaned between
(patients) every individual test.
• Local infection control requirements may supersede both manufacturers’

recommendations and those in this document.
• For more details refer to the following articles-

• ATS/ERS 2019 guidelines

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• Recommendations for undertaking risk-managed spirometry

• ATS Pulmonary Function Laboratory Management and Procedure Manual
7. Purpose
• Spirometry, which means “the measurement of breath,” is a routinely used pulmonary
function test (PFT) that measures the volume and flow(speed) of air that a person can
inhale and exhale. Results from the test can be used to estimate lung function and aid
in the diagnosis of certain respiratory disorders.
• The CDDP ClinSpark Portal will be used to collect subject demographics and launch
testing software as well as receive and display spirometry results.
• The EasyOne Connect software will be launched from CDDP ClinSpark portal and
serves to control the Easy on-PC sensor, guide the spirometry testing using subject
data from CDDP ClinSpark portal, as well as report the test results.

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8. Login to CDDP ClinSpark portal

Once you have verified the devices and supplies, confirmed the internet connectivity,
and reviewed the training materials, you should login to IQVIA CD provisioned laptop
Using the login id provided along with the laptop and access CDDP ClinSpark portal
using the login credentials provided by IQVIA CD via email.
CDDP Site Gateway Login Screen:
https://cddp.solutions.iqvia.com
CDDP Site Gateway Landing Page:

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CDDP ClinSpark portal login page:
Note: site to setup same password as used for CDDP Site gateway login.
The 'Email Password Reset' link will become visible to you after you have failed login
at least one time. Please refer to Appendix A: Initial login and Password Reset of this
manual for detailed instructions for changing the password. Please contact the IQVIA
helpdesk for further assistance
NOTE:
1) You will receive access to Gates-MRI-TBD06-201_ Proficiency Testing database

first. Upon successful completion of Proficiency test, you will be granted access to
Gates-MRI-TBD06-201 database for uploading Spirometry test.
2) You should ensure that the Proficiency test are uploaded on
Gates-MRI-TBD06-201_ Proficiency Testing database
3) The subject Spirometry test should be uploaded on Gates-MRI-TBD06-201
database.

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11. Technician certification process/Proficiency testing for

technicians
➢ A consent form for volunteers who participates in proficiency test must be signed,
before completing the proficiency test and that report must be stored at site. Kindly
refer Appendix D for sample consent form.
The certification process consists of the following steps:
• The site technician logs into the CDDP ClinSpark portal test application ie
Gates-MRI-TBD06-201 _ Proficiency testing using his/her unique credentials
provided by IQVIA. (The login credentials must be sent by IQVIA CD via email to
the site)
• To pass the proficiency test, the technician should perform two spirometry tests
(on two volunteers). Each spirometry test should include at least 3 acceptable
maneuvers, out of which 2 maneuvers should be repeatable with both FEV1 and
FVC having a grade A. (Please refer Appendix F for quality grade)
• Maximum 8 maneuvers can be performed to obtain the above acceptability and

repeatability criteria.
• For Proficiency test any healthy volunteers can be selected. e.g: Co workers
• Proficiency test will be reviewed by an IQVIA overreader and spirometry

proficiency report will be provided via email. (Refer Appendix E for sample
proficiency test report). Site is requested to file the report in the study file.
• In case of unacceptable proficiency tests, site technician is required to follow

the instructions provided on the spirometry proficiency report.
Note: The site technician will be granted access to the live study database ie
Gates-MRI-TBD06-201 only after passing the proficiency test and access to the
proficiency database ie Gates-MRI-TBD06-201 _ Proficiency testing will be
revoked.

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9.1 Enrollment for proficiency testing/certification

• Proficiency testing will be performed in the test instance ie Gates-MRI-TBD06-201 _
Proficiency testing of CDDP ClinSpark portal for which Site will be provided login
credentials.
• Prior to performing Easy on-PC spirometry proficiency testing for new volunteer, the
volunteer should be enrolled in the CDDP ClinSpark portal using Dummy demographics
details.
• Access to proficiency testing will be revoked when testing is passed.
• IQVIA CD PM and IQVIA CD over reader will keep list of users who passed the test.
➢ Perform the following steps to enroll a new volunteer in Gates-MRI-TBD06-201 _

Proficiency testing of CDDP ClinSpark portal:
• Go to ‘Data Collection’ – ‘Subject’. The ‘Subject Search’ page opens.
• Click ‘Enroll’.
• Enroll Subject page opens which allows the staff to enter the subject demographic
information. Please enter dummy information for proficiency subject enrollment.
• Kindly note that the “Screening Number” field as shown in the below screenshots,
will automatically be populated as “TEST –X “, where “X” is the number from 1 to N (N
is unlimited). Hence site needs to enter ONLY the below demographics information:
1. Sex
2. Date of Birth
3. Height (m)
4. Weight (kg)
5. Race
• Enter subject’s height up to two decimal points in meters e.g., 1.67m (167cm).
Height and weight should be recorded using calibrated equipment.

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• Verify subject demographics are entered correctly and then click ‘Save’.
• The data collection screen must be displayed.
• The following two forms will be available for data collection:
1. Calibration form
2. Spirometry form

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9.2 Required materials for performing calibration check
✓ A calibration syringe.
✓ A spirette cal check adapter.
✓ A spirette.
1. Remove the provided 3L syringe from plastic covering.

2. Remove the red dust cap from end of syringe.
3. Place NDD Spirette Cal Check Adapter in end of syringe and ensure it is firmly in
place.
4. Place the clean Spirette in Easy On-PC and secure mouthpiece under the clips of
the spirette adapter. You must ensure that this connection is firm and secure to
prevent any leaked air during the testing.
▪ We recommend that you write ‘calibration’ on the spirette and reuse for
future calibration check/verification
▪ Replace with a new syringe if you get inaccurate results or it looks worn.
▪ Store the spirette used for calibration verification in the calibration syringe
box/bag.
5. Place the syringe on a flat surface and ensure the plunger is pressed all the way
into the syringe to begin testing.

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6. Plug in the Easy on-PC to the laptop USB Port.
9.3 Multiflow calibration check/verification for proficiency test
• Collect the calibration form to perform the calibration for proficiency test.
• A multiflow calibration check should be performed on the device prior to completing

spirometry test.
• Click on Invoke device.
• A pop-up message of " An order has been created. Please use EasyOneConnect to
complete the test and then press 'ok' when EasyOneConnect is closed’ message will
display on screen.
• The NDD Easy on-PC software will open.

• Answer Inline Filter Question
o If using filters in the trial, we recommended performing the calibration
verification with the filter in place.

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• At prompt "Attach Spirette to Syringe with Adapter", insert the clean spirette into the
Easy On-PC and place the spirette mouthpiece under the Cal Check Adapter clips.

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• Do not move the syringe or Easy On-PC while the baseline is being set.
• Follow the prompts on the screen.
• The multiflow Calibration check will guide you through 3 efforts of increasing flow
rates: 0.5 l/s, 1.0 l/s and 6.0 l/s.
• Pull the plunger out all the way until you hear the audible hard stop. Try to do
this quickly and smoothly where possible.
• Push the plunger in, attempting to keep the developing line on the screen within
the orange Flow Target Range.
• Push the plunger in all the way until an audible sound when the plunger is fully
deployed in the syringe.
• At the end of the test, if a 'good effort, do next…' was determined, when you
select 'Add Trial' you will automatically be asked to perform the calibration
check at the next higher flow rate.
• If the test was failed, a prompt indicating two different types of errors will display:
o "Try again- - Flow criteria not met!" means that you did not keep the flow
rate within the orange flow target range. Please attempt the trial again
keeping within this range. Please Note that at the 6.0 L/s flow rate, it is
impossible to keep the entire line at this rate, so quickly performing the
maneuver with as much of the rate in 6.0L/s range as possible should
be the goal.
o “Calibration result out of range – Check setup” means that the device
did not measure 3L of air within the acceptable deviation. Please check
that all connections on the syringe, device and adapter are secure. You
may even want to hold the spirette in place with your other hand as you
depress the syringe. Finally, try to keep the syringe movements as
smooth as possible.
• Selecting 'Add Trial' will allow the user to attempt the test again at the current
flow rate.
• In the case that the test is failed, continue attempting the effort at least 5 times.
New users may require some practice to get the flow rate correct.
• Single clicking on failed attempt trial number (with the line through it) will display
the problem and solution
• Three total successful efforts, one at each flow rate, will end the test and
“Calibration Check completed successfully!” will display!”

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• Click on Finish button on EasyOne Connect.

• Click on Ok on “An order has been created. Please use EasyOneConnect to complete
the test and then press 'ok' when EasyOneConnect is closed.” message.
• The form will fill with the result.

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• Click on Save and return.

• Click on View on REPDF to view the result.

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• Select Report to see the PDF for the calibration check. Failed attempts will not be
displayed if the calibration check was completed successfully.
• If technician fails to complete calibration, they should follow the troubleshoot and
repeat the calibration check.
• They still can perform spirometry proficiency test if calibration check fails.
• Overreader will give further instructions in proficiency report.
9.4 Repeat calibration check

➢ To repeat calibration please follow the below steps:
• Go to data collection – Subject – Search the completed form.
• Click on collect on completed form.

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• Click on add repeat form.
• Make sure the below highlighted form item is selected.

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• Click on add form.

• Click on invoke device to perform calibration.
• Follow the same process mentioned above to perform calibration.
9.5 Perform trial for proficiency test

• Click on collect on proficiency form.
Note: For Test preparation,subject coaching,Acceptability and repeatability criteria and

Contraindications please refer Section13

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• Once the form is loaded, click on the “Invoke Device “button.
• A message will display indicating “An order has been created. Please use EasyOne
Connect to complete the test and then press 'ok' when EasyOne Connect is closed.” Do
not press “OK” and leave this message for now. You will acknowledge it when the test is
over.
• Shortly after, the EasyOne Connect software will load in a separate window

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• Use a hygrometer to determine the Ambient Temperature & Humidity. The

environmental temperature must be within 1°C accuracy.
• The altitude will be preconfigured. Please check that the altitude is within +/- 300 meter
compared to the altitude provided in the envelope (together with the login) with the device.
Note: site should login into the below link and check the altitude
• https://whatismyelevation.com/
Or
• https://www.freemaptools.com/elevation-finder.htm
• Once the values are displayed, verify the environmental data and update as needed.
In case you change any parameter, select “Recalculate BTPS” to update the BTPS used
during testing. Click on the “Confirm >>” button.

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• EasyOne Connect software displays the testing screen.

• Answer the question regarding whether a filter is being used with the device.

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• Click Ok on “Block the spirette until prompted to blast out”.
• A notification will display indicating that the device is setting the baseline. Keep the
plastic wrap from the spirette on the end until you’ve been notified to start the test.
Alternatively, if the plastic wrap is not available, have the subject use their hand to
block the back of the spirette and to hold the device very still.
• Ask the subject to place the nose clip on their nose to perform the test.
• Tell the subject to breathe at rest and sit up straight with both feet on the floor.
• When Start test … is displayed.

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• Tell the subject to take the spirette into their mouth and to seal their lips around the
spirette. The subject must not block the opening with the tongue or teeth or bite down
excessively on the spirette.
• Tell the subject to fully inhale and forcefully exhale.
• Keep motivating the subject to fully exhale all air from the lungs until the test is
ended automatically by the software. The subject should then take a deep inhale
through the spirette, and the software will end the test when the end of test criteria is
reached.
• Tell the subject to take the spirette out of the mouth and to breathe normally again.
• If the trial is acceptable, “Good effort, do next” message must display on screen.

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• Each spirometry test should include at least 3 acceptable maneuvers, out of

which 2 maneuvers should be repeatable with both FEV1 and FVC having a grade
A.
• Proficiency test will be reviewed by an IQVIA overreader and spirometry
proficiency report will be provided via email. Site is requested to file the report in
the study file.
• In case of unacceptable proficiency tests, site technician is required to follow

the instructions provided on the spirometry proficiency report.
Note: The site technician will be granted access to the live system only after passing
the proficiency test and access from the proficiency test system will be revoked.

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11. Enrollment for spirometry test in CDDP ClinSpark portal

Prior to performing Easy on-PC spirometry data collection for each new subject, the
subject should be enrolled in the CDDP ClinSpark portal.
Perform the following steps to enroll a new subject:
• Go to ‘Data Collection’ – ‘Subject’. The ‘Subject Search’ page opens.
• Click ‘Enroll’.
• Enroll Subject page opens which allows the staff to enter the following subject
demographic information.
• View the screenshot below to enter subject demographic information.
Note: Enter subject’s height up to two decimal points in meters e.g., 1.67m (167cm).
Height and weight should be recorded using calibrated equipment.

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• Verify subject demographics are entered correctly and then click ‘Save’. “The subject
has been saved message “must display on data collection screen.
• Click on the Collect button on Easy On-PC Spirometry Baseline form
12. Search the already enrolled subject on CDDP ClinSpark portal

.
• Go to Data Collection → Subject.
• Select the already enrolled subject.
• Click on the Collect button on Easy On-PC Spirometry Visit form

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• A message will display indicating “An order has been created. Please use
EasyOneConnect to complete the test and then press 'ok' when EasyOneConnect is
closed.” Do not press “OK” and leave this message for now. You will acknowledge it
when the test is over.
• Shortly after, the EasyOne Connect software will load in a separate window.

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• The altitude should be entered for your specific site. Please check that the altitude is
within +/- 300 meter compared to the altitude provided by IQVIA CD along with with the
device.
https://whatismyelevation.com/
https://www.freemaptools.com/elevation-finder.htm
during testing

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• Click on the “Confirm >>” button.

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13. Race mapping
➢ Follow the below mentioned table for reference:
CDDP ClinSpark Portal NDD EOC
American Indian or Alaska Native N/A

Asian Asian
Black or African American African
Hispanic Hispanic
Native Hawaiian or Other Pacific Islander N/A
North-East Asian North-East Asian
South-East Asian South-East Asian
Other Race Other
Unknown Other
White Caucasian

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14. Prepare for the test
• Partly unwrap the spirette. For hygiene reasons, grip the partly unwrapped spirette
only with the wrapper at the mouthpiece. Do not touch the spirette.
• Fully insert the spirette into the spirette holder as depicted below but keep the
partly unwrapped wrapper on the mouthpiece of the spirette.

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13.1 Subject coaching

Note: site staff /technicians should be trained on the spirometry procedure,
acceptability, and repeatability criteria as per the ATS/ERS 2019 guidelines (available
at https://www.atsjournals.org/doi/full/10.1164/rccm.201908-1590ST
• Explain and demonstrate the test maneuver to the subject prior to beginning the test.
• You may use a spirette for this demonstration. Ensure you demonstrate the full
maneuver, including a deep inhalation and forced exhalation until your lungs are empty.
It is important that the subject sees a full effort.
• The subject's chest should not be restricted from expanding by tight fitting clothing
(e.g., belts or vests). The subject should sit straight and upright in a chair with no wheels
and keep their head elevated to ensure airways are open.
• Allow the subject to perform trial runs using the spirette.
• When performing the test, ask the subject to hold the mouthpiece between the teeth,
close lips tightly around it, ensure that the mouthpiece is not obstructed by the tongue.
Instruct subject to inhale completely and deeply until their lungs are fully inflated (up to
Total Lung Capacity).
Note: This is the most crucial step in spirometry. If inadequate breath is taken, the
spirometry parameters will show inaccurate low values. The FEV1/FVC ratio will also be
falsely elevated, thereby under-diagnosing obstructive airways diseases.
• The subject should sit straight and upright.
• With no pause at TLC (after taking a complete and deep inhalation) instruct the
subject to exhale (blast out the air) as hard and as fast as possible.
• Instruct the subject to continue exhaling till no more air can be expired or exhaled i.e.,
up to forced vital capacity or maximum 15 seconds or until a plateau of one second is
achieved) followed by a deep and complete inspiration/exhalation.
• Encourage the subject to maintain an upright posture (i.e., no bending forward) during
the maneuver.

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13.2 Acceptability criteria and repeatability criteria.

• Both the graphs (volume vs time and flow vs volume) should start from point zero
mark without any hesitation and delay followed by a sharp peak.
• There should be no cough during the first second of exhalation.

• No early termination.
• No air leaks between the lips and spirette.
• No obstructed mouthpiece (blocking the mouthpiece with the tongue).
• There should be continuous maximal exhalation until a plateau is achieved (FVC
achieved) or maximum15 seconds.
Acceptability Criteria: Out of these 3 acceptable trials, 2 trials should meet the
following repeatability criteria. A maximum of 8 tests can be performed to achieve the
acceptability and repeatability criteria.
Repeatability Criteria: The two largest values for FVC should be within 150 ml.
The two largest values for FEV1 should be within 150 ml.

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13.3 Contraindications
Note: For detailed list of contraindications refer to ATS/ERS 2019 guidelines.

The spirometry test should be performed at the discretion of the Investigator
Considering the safety of the study participant.
➢ Following are the contraindications for spirometry (These are general

contraindications):
• Myocardial infarction in the last month

• Unstable angina in the last month
• Hemoptysis of unknown origin in the last month
• Eye surgery in the last month
• Diagnosed cases of thoracic, abdominal, or cerebral aneurysms
➢ Abdominal or thoracic surgery

• Pneumothorax
• Facial palsy
• Pregnant woman
➢ If the clinician wants to determine whether there is any evidence of reversible airflow
limitation, then the subject should undergo baseline function testing when not taking any
drugs prior to the test.
➢ Short-acting inhaled drugs (e.g., the beta agonist albuterol/salbutamol or the

anticholinergic agent ipratropium bromide) should not be used within 4 h of testing. Long-
acting b-agonist bronchodilators (e.g., salmeterol or formoterol) and oral therapy with
aminophylline or slow-release b-agonists should be stopped for 12 h prior to the test.
Smoking should be avoided for o1 h prior to testing and throughout the duration of the
test procedure.
➢ Tests should be performed at Investigators discretion.
Relative Contraindications: uncooperative subject or any other condition in which a

forceful maneuver can cause stress.

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15. Multi-flow calibration check/verification for spirometry test

• Perform simple calibration check/verification to determine whether the Easy on-PC
sensor operates normally. Therefore, per ATS/ERS 2019 guidelines it is
recommended to perform a multi-flow calibration verification to ensure the reliability of
the tests. The American Thoracic Society (ATS)/ERS recommends that the multi-flow
calibration verification must be performed on each day where spirometry tests are
scheduled prior to performing any tests with subjects.
• Site to perform calibration on the visit day before recording.
• The site will have to respond to the question if the calibration check was successful
before they click on the visit form.
• If the site responds “No”, they will be asked if they called IQVIA CD Helpdesk for real
time assistance and will have to enter the reason for the unsuccessful calibration.
• The site will be allowed to continue with the recording even if they respond as “No” to
the question if the calibration check was unsuccessful.
• Internally, IQVIA CD PM will pull the questionnaire report every 15 days and ask the
IQVIA CD Helpdesk to call the sites who have responded as “No” to the question if
the calibration check was unsuccessful.
• If there are any errors that you are not able to rectify through multiple re-attempts of
the verification, please contact the IQVIA CD helpdesk for next steps.
If the calibration check fails:
• The site should ask second technician to perform calibration verification.

• If the calibration check fails again, site should contact IQVIA CD helpdesk
immediately.

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14.1 Required materials for calibration verification
✓ A calibration syringe.
✓ A spirette cal check adapter.
✓ A spirette.
7. Remove the provided 3L syringe from plastic covering.

8. Remove the red dust cap from end of syringe.
9. Place ndd Spirette Cal Check Adapter in end of syringe and ensure it is firmly in
place.
10. Place the clean Spirette in Easy On-PC and secure mouthpiece under the clips of
the spirette adapter. You must ensure that this connection is firm and secure to
prevent any leaked air during the testing.
▪ We recommend that you write ‘calibration’ on the spirette and reuse for
future calibration check/verification
▪ Replace with a new syringe if you get inaccurate results or it looks worn.
▪ Store the spirette used for calibration verification in the calibration syringe
box/bag.

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11. Place the syringe on a flat surface and ensure the plunger is pressed all the way
into the syringe to begin testing.
12. Plug in the Easy on-PC to the laptop USB Port.
14.2 Calibration verification Process
Note: Site to perform calibration on the visit day before recording.
• Login to CDDP ClinSpark portal with user credentials provided by IQVIA.

• Go to data collection – subject – search the subject by device serial number.
(Beginning with SN)
• “Collect” the <Calibration form>.
• Click on Invoke device.

• A pop-up message of " An order has been created. Please use EasyOneConnect
to complete the test and then press 'ok' when EasyOneConnect is closed’ message
will display on screen.

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• The ndd Easy on-PC software will open.

• Answer Inline Filter Question
o If using filters in the trial, we recommended performing the calibration
verification with the filter in place.
• At prompt "Attach Spirette to Syringe with Adapter", insert the clean spirette into the
Easy On-PC and place the spirette mouthpiece under the Cal Check Adapter clips.

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• Do not move the syringe or Easy On-PC while the baseline is being set.
• Follow the prompts on the screen.
• The multiflow Calibration check will guide you through 3 efforts of increasing flow
rates: 0.5 l/s, 1.0 l/s and 6.0 l/s.
• Pull the plunger out all the way until you hear the audible hard stop. Try to do
this quickly and smoothly where possible.
• Push the plunger in, attempting to keep the developing line on the screen within
the orange Flow Target Range.
• Push the plunger in all the way until an audible sound when the plunger is fully
deployed in the syringe.
• At the end of the test, if a 'good effort, do next…' was determined, when you
select 'Add Trial' you will automatically be asked to perform the calibration
check at the next higher flow rate.
• If the test was failed, a prompt indicating two different types of errors will display:
o "Try again- - Flow criteria not met!" means that you did not keep the flow
rate within the orange flow target range. Please attempt the trial again
keeping within this range. Please Note that at the 6.0 L/s flow rate, it is
impossible to keep the entire line at this rate, so quickly performing the
maneuver with as much of the rate in 6.0L/s range as possible should
be the goal.

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o “Calibration result out of range – Check setup” means that the device
did not measure 3L of air within the acceptable deviation. Please check
that all connections on the syringe, device and adapter are secure. You
may even want to hold the spirette in place with your other hand as you
depress the syringe. Finally, try to keep the syringe movements as
smooth as possible.
• Selecting 'Add Trial' will allow the user to attempt the test again at the current
flow rate.
• In the case that the test is failed, continue attempting the effort at least 5 times.
New users may require some practice to get the flow rate correct.
• Single clicking on failed attempt trial number (with the line through it) will display
the problem and solution
• Three total successful efforts, one at each flow rate, will end the test and
“Calibration Check completed successfully!” will display!”

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• Click on Finish button on EasyOne Connect.

• Click on Ok on “An order has been created. Please use EasyOneConnect to
complete the test and then press 'ok' when EasyOneConnect is closed.” message.
• The form will fill with the result.

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• Click on Save and return.

• Click on View on REPDF to view the result.

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• Select Report to see the PDF of the calibration check. Failed attempts will not be
displayed if the calibration check was completed successfully.
• If calibration fails, the site should ask second technician to perform calibration
verification.
• If the calibration check fails again, request site to contact IQVIA CD helpdesk
immediately
Note: Please contact the IQVIA CD helpdesk team for any necessary equipment
replacement or supply re-order. Please do consider a turnaround of at least 2 weeks for
the additional supply to be shipped.
Closing calibration check database

1. Select Username at the bottom left-hand corner and select Logoff.
2. Close the application by selecting Exit.

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14.3 Error message for wrong device used for calibration verification
Note: If two devices are assigned to each site then both devices will be enrolled using
the serial number. Sites would be able to see both device serial numbers while selecting
it under the Subject Id details. If the Serial number selected under Subject Id details is
not the same as the device used for collecting Calibration Form, then edit check would
fire notifying the site of this error. In such case, Site should not save the form, but close it
and re-perform the Calibration using the correct device.
• If user used wrong device for calibration and invoke the device the below error
message must display.
14.4 Repeat calibration check
➢ To repeat calibration please follow the below steps:

• Go to data collection – Subject – Search the completed form.
• Click on collect on completed form.

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• Click on add repeat form.
• Make sure the below highlighted form item is selected.
• Click on add form.


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• Click on invoke device to perform calibration.

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16. Perform Trial for Spirometry Test

• Click on collect on calibration reminder form.
• Answer the Calibration reminder questionnaire form.

➢ The site will have to respond to the question if the calibration check was
successful before they click on the visit form.
• If the calibration is completed for the device select “Was daily calibration passed today”
as “Yes” and continue with the spirometry test.

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• Click on Save and Close.

• If calibration is not completed for the device, select the “Was daily calibration passed
today” as “No” and continue with the spirometry test.
Note: Internally, the PM will pull the questionnaire report every 15 days and ask the
Helpdesk to call the sites who have responded as “No” to the question if the calibration
check was not successful
• Click on save and close and continue with the spirometry test.
• Click on collect on Spirometry visit form.

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• A message will display indicating “An order has been created. Please use EasyOne
Connect to complete the test and then press 'ok' when EasyOne Connect is closed.”
Do not press “OK” and leave this message for now. You will acknowledge it when the
test is over.

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• Shortly after, the EasyOne Connect software will load in a separate window
.

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• The altitude will be preconfigured. Please check that the altitude is within +/- 300 meter
compared to the altitude provided in the envelope (together with the login) with the device.
• https://whatismyelevation.com/
Or
• https://www.freemaptools.com/elevation-finder.htm
during testing. Click on the “Confirm >>” button.

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• Answer the question regarding whether a filter is being used with the device.
• Click Ok on “Block the spirette until prompted to blast out”.
• A notification will display indicating that the device is setting the baseline. Keep the
plastic wrap from the spirette on the end until you’ve been notified to start the test.

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Alternatively, if the plastic wrap is not available, have the subject use their hand to
block the back of the spirette and to hold the device very still.
• Ask the subject to place the nose clip on their nose to perform the test.
• Tell the subject to breathe at rest and sit up straight with both feet on the floor.
• When Start test … is displayed.
• Tell the subject to take the spirette into their mouth and to seal their lips around the
spirette. The subject must not block the opening with the tongue or teeth or bite down
excessively on the spirette.
• Tell the subject to fully inhale and forcefully exhale.
• Keep motivating the subject to fully exhale all air from the lungs until the test is
ended automatically by the software. The subject should then take a deep inhale
through the spirette, and the software will end the test when the end of test criteria is
reached.
• Tell the subject to take the spirette out of the mouth and to breathe normally again.
• If the trial is acceptable, “Good effort, do next” message must display on screen.

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• If the trial is not acceptable, a yellow or red quality message is displayed

suggesting how to improve the breathing maneuver. Select the smiley face to see
details on how to improve the quality of the maneuver (Refer to Acceptability and
repeatability criteria 14.2).
• If the subject has not fully exhaled or exhaled for a long enough duration, the
system will display the message “Exhale longer until completely empty “.

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15.1 Collect visit form without doing Calibration
➢ If calibration is not performed for the device and the visit form is collected, the following
steps to be followed.
• Don’t collect calibration form.

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• Collect visit form.
• “In order to collect on this form, Calibration Reminder Form must not be Unsaved.
Please complete the required form or provide a comment as to why collection is
occurring out of order:” message must display.
• Select the Comment Option and give reason on Comment section and click on
Save.

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• Click on “Invoke Device” to perform the spirometry test.
15.2 Add trial in EasyOne Connect
Add Trial can be selected to add additional Trials or if the trial times out due to inactivity
and the trial needs to be restarted
The protocol specifies a waiting time of <xx time> between trials ‘Remove if not
applicable’. The trial recording time is indicated as seen on the screenshot below
• Choose Add Trial.
• Follow the instructions on the screen and repeat the previous breathing maneuver.
• Continue to add trials until the green “Session Complete!” message is displayed. A
maximum of 8 trials can be performed to achieve the acceptability and repeatability

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criteria.
• In the Test Information area, the quality grade for the test is displayed.
• After three successful trials “Session complete! Great job!” message must display
on screen.
Note: Maximum 8 trials can be performed to achieve 3 acceptable trials, if first three
trials are acceptable and meet the repeatability criteria then no need to perform more
trials.
• Click on Finish button

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17. Import results into CDDP ClinSpark portal

• Once the test is finished the pop-up message of "An order has been created. Please
use Easy on-PC to complete the test”, will still display on CDDP ClinSpark portal and
the EasyOne Connect software will close automatically.
• Click OK on the pop-up message to import the results from EasyOne Connect.

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• The form will auto fill with the best values from the spirometry session and a
PDF of the test results will be saved.
• Click on the Save and return button.

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• Clink on the ‘View’ hyperlink under REPDF to view the result in PDF format
• The PDF report will open.

• Report can be downloaded by clicking on download option and can be printed by
clicking on print option.

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Note: Site should not print or store the report until IQVIA CD overreading process has
occurred and the final trials have been selected for the Spirometry test’s best values.
• Close the form by clicking on close option.

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16.1 Audit trial before overreading
• Users can check the audit trial of the report by following the steps below.
➢ Click on Study → Data → search the subject → Status → Completed
➢ Click on Action → Collect

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➢ Click on Item → Action → Audit
➢ The audit record of the report must be displayed.

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16.2 Adding Additional trials to a current test

• If a subject can’t perform 3 maneuvers, the test still can be saved.
• Please follow the below steps for the same:
• Click on finish button.

• Click Ok on the pop-up message to import the results from EasyOne Connect.

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• The form will auto fill with the best values from the spirometry session and a PDF
of the test results will be saved.

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• Click on Save and return button
• To continue and perform further trials on the pending test, please follow the below
steps.
Note: you may only add additional trials on the same day that the test was initiated.
You may have to login and locate the form again:
• Click on item group→ actions→ Collect

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• Click on invoke device

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• EasyOne Connect will open.

• Confirm BTPS settings if required
• “The select subject already performed a test today. Please select “message must
display on screen.
• Clock on “Add trial” button to perform the trial.

• Confirm Filter settings. The system should remember your previous settings
• Click on ok on “Block the spirette until prompted to blast out” message.

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• Guide the subject through the maneuver, selecting “Add Trial” to perform additional
maneuvers.
• Once all additional trials have been added, Click on the finish button.

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• Click on Click Ok on the pop-up message to import the results from EasyOne
Connect.
• The fields will be populated with the updated information if the best value changed
by adding additional trials.
• Click on “Save and return” to save the current result to CDDP ClinSpark portal.
16.3 Unscheduled visit

➢ If the subject visits the clinic, which is not on a scheduled date and the test is
required to be taken then an unscheduled visit can be used.
➢ Follow the below steps for the same:

• Go to data collection- subject - select the subject to add unscheduled visit.
• Select the study event and click on Add button.

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• Select the form and click on add form.
• The form has been added message will display on screen.

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16.4 Repeat visit
To repeat the trial, follow the below steps:

• Go to data collection à select the subject
• Collect the form.
• The form must open

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• Click on Form -Action- Add repeat
• Select the form to repeat. Keep all items selected as a default.
• Click on Add form

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• The form has been added will display on screen

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18. IQVIA Overreader quality review

• Spirometry study reports will be reviewed as per the ATS/ERS 2019 spirometry
guidelines. If the trial is modified (accepted or rejected) by IQVIA CD over reader,
then an appropriate reason (trial comments for FEV1 and FVC) will be provided.
Additionally Overall feedback will be provided by IQVIA CD over-reader (The
overreader feedback, FEV1 and FVC trial comment will be available in ClinSpark)
within 24 hours of the study.
• Upon completion of overreader quality review the sites will receive an email
notification. The sites will have to login and take a printout of overeader reviewed
report and the site should use this report for EDC entry.
19. Report after overreading

To verify whether overreading is completed for the subject, follow the below steps:
• Go to study → Data → select the overreading form → select the Reviews as

reviewed → Search
• If the status is reviewed the overreading is completed for the subject.

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• Click on view to view the report after overreading.

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• The over readers comments must be displayed in the bottom of the report.
• The reason and the changes made by overreader can be seen below in CDDP
ClinSpark portal.

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• If the status is not reviewed, then overreading is not completed for the subject.

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18.1 Audit trial after overreading
• Go to study → Data → select the overreading form → select the Review as reviewed
→ Search
• Click on Action → Collect
• Click on Item Actions → Audits

• The audit trial of that report must display.

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20. Workflow for principal investigator

.
• If the PI reviews IQVIA CD overreader comments and has any further query, the PI
can reach out to IQVIA CD study PM. (Email: Parul.udeshi@quintiles.com )
• Click on collect “PI Form” in CDDP ClinSpark portal.
• Click on Action- Collect on “PI Comments”

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• Under the “PI to add Feedback” section, provide your comments

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• Click on ‘Save and Return’
• Close the form

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21. Responding to a query and associated detail
20.1 How to identify and resolve outstanding queries

✓ On the Study Dashboard screen, you will get the number of queries outstanding for
your Site ID.
✓ Either click on the VIEW MORE to go to the query list or Go to the Study Data
screen.
✓ Select Queries status as Unanswered and/or answered and/ or closed and click on
Search.
o Red? indicates query is outstanding.

o Yellow? indicates query answer is provided.
o Green? indicates query is resolved.

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➢Click on red? hyperlink to resolve the query:

✓ Item Data Details screen will open. The option to enter an answer will display under
that as shown in below picture.
✓ Click on Save. Query response will be saved in the CDDP ClinSpark portal.

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20.2 How to export the query listing

✓ Go to the Study Data screen
✓ Select Queries status as Unanswered and/or answered and/or closed and click on
Search.
✓ Click on Export Queries
✓ Query listing will be downloaded in excel format.
NOTE: If the DCF remains outstanding for 15 days, IQVIA CD will send reminders twice. If
the DCF still remains outstanding it will be sent to the clinical team for further follow up.

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22. Dashboard
21.1 Spirometry Value Trend Graph
Investigators, sponsors, and other clinicians can view the spirometry value trend graph in
the CDDP ClinSpark portal dashboard so that individual Spirometry values that are
considered clinical endpoints in the study, can be focused that allow trend tracking,
efficacy determination and clinical oversight.
• Click on Dashboard – Spirometry Trend

• Select Subject and Item
• The trend graph for the selected subject along with the Item selected must display.
• The user can pick multiple items from all numeric items associated with Spiro data
collection forms for the subject.
➢ Predicted value items are identified by their name being suffixed with
‘_predicted’ while the prefix matches the name of another item on the form.
➢ Percent predicted value items are identified by their name being prefixed with
'Percent ' while the rest of the name matches the predicted value item.
➢ Predicted values for an item should be plotted alongside the item when it is
selected, using a dotted line for predicted and solid for actual.

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➢ If the user picks items which share a single unit, the chart will show that unit on
the left axis.
➢ If the user picks items which share two units, one unit will be shown on the left
axis with the second on the right axis.

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➢ If the user picks items that share more than two units, no chart will be shown,
and it will be replaced by the message “Please pick parameters that share a
maximum of 2 distinct units
21.2 Quality Metrics Dashboard
User can view the Spirometry Quality Metrics in the CDDP Clinspark portal dashboard so
that the quality of Spirometry performed by sites is consistently reviewed during a trial. It
tells users how well the site is performing spirometry maneuvers, the quality of the data,
and if retraining of site technicians is required. This dashboard will be used for site and
study oversight by project management, over-readers, sponsors, and other operations
team members.
• Click on Dashboard --- Spirometry Quality Metrics’

• The dashboard named ‘Spirometry Quality Metrics’ must be visible for Spirometry
studies.

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• The following selection parameters shall be available for the dashboard

a. Site (List of unique Site ID associated with the site at the study level)
b. Technician (The name of the technician who performed the spirometry/DLCO/MBW
Assessment)
c. Month
• User shall be able to select one of the following:

i. FEV1
ii. FVC

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iii. FEV1 and FVC

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• The ‘acceptable’, ‘unacceptable and usable’, ‘unacceptable and unusable’ readings

shall be color coded as in the table above.
• High Quality Percentage: Percentage of all assessments with a Grade A-E out of
total number of assessments. It is a tabulation of all Grade A through Grade E Quality
Grades based on the current filter selections, then divided by total assessments based on
current filter selections.
Note: This % calculation will need to be customized on a per study basis. For example, on
one study, high quality may be Grades A-B only.

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• Low quality Percentage: Percentage of all assessments with a Grade U (2019

standards only) or Grade F out of total number of assessments. It is a tabulation of all
Grade U and F Quality Grades based on the current filter selections, then divided by total
assessments based on current filter selections.
Note: This % calculation will need to be customized on a per study basis. For
example, on one study, low quality may be Grades C, D, E, F and U.
• The low-quality percentage should tally with the ‘unacceptable and usable’ and
‘unacceptable and unusable’ columns
• Number of assessments: Grade A to F plus U


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• Any adjustment to the Spirometry Assessments during the overread process shall be
reflected when the report or dashboard is generated.
• Before overreading FEV1 =A and FVC = C

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• Dashboard also showing the same value.
• After overreading the grade is changed to FEV1 =B and FVC =B
• Dashboard also showing the same value.

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• The over reader or sponsor may want further indication of the reason for unacceptable
tests - the unacceptable percentage shall have hyperlinks displayed which when selected
shall display the underlying data in an additional table

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23. Reports for subjects enrolled on site

22.1 Study subject report
• Following Reports are available to Site Users for subjects enrolled under the site.
Please navigate to Study - Report menu to generate - Study Subject Report

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22.2 Clinical data report
• Navigate to Study - Report - Generate - Clinical Data Report

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24. Site responsibilities at close out

• Ensure all subject data is available in CDDP ClinSpark portal and reports are
saved IQVIA provisioned laptop and Spirometer should be returned to IQVIA in the
original packaging.
• Upon sponsor direction, IQVIA will send preprinted air waybill (AWB) to initiate the
recall process.

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25. Project contact information

IQVIA Contact Center (24 x 7 Multilingual)
Contact the IQVIA Contact Center for Helpdesk Toll Free Phone Numbers
Assistance with the following:
• Equipment troubleshooting
Kindly review the table below for Helpdesk Toll
• Ordering Supplies
free phone numbers
• Requesting IQVIA to raise a data
query
• Site closeout
• Request for grant/revoke access
to CDDP ClinSpark portal
Country Helpdesk Number (Toll Free)

Kenya 020 3892111 (Non-toll-free)
Peru (0800) 52864
Philippines 1800 1 441 0185
1800 8 908 6366
South Africa 080 099 1338
Uganda 0800 113209
Vietnam 1201 1155
Email
• Ordering supplies, CSSCDSupport@quintiles.com
• Any other project related queries
Fax Numbers:
2nd Dialing Option [ITFS 3rd Dialing

Country 1st Dialing Option [UIFN]
As Back Up] Option
1010-5511-
00/105-11
Add AT & T
Common Number
Philippines +800-72720030 1-800-1-114-2245 866-373-4072
South
Africa +800-72720030 080-09-82652 0-800-99-0123

Page 118 of 139
Add AT & T
Common Number
866-373-4072
3rd Dialing
Country 1st Dialing Option [ITFS] 2nd Dialing Option [AT&T] Option [US Toll
As Back Up]
0-800-50-288/0-800-70-088 +1-919-323-3710
Add AT & T Common
Peru 0800-54316 Number 866-373-4072
1-201-0288
Add AT & T Common
Vietnam 120-11108 Number 866-373-4072
Country 1st Dialing Option [US Toll]

Kenya +1-919-323-3710
Uganda +1-919-323-3710
Note:
➢ Site should provide the following information when contacting the IQVIA CD help
desk:
• Site name
• Study/Protocol ID
• Study sponsor
➢ For resupplies Site should provide the following information when contacting the
help desk:
• The product or consumable needed
• The quantity needed
• The date of the next subject visit/required delivery date
• Please do consider a turnaround of at least 2 weeks for the additional supply to be
shipped.
25. Internet Outage

• Spirometry test can’t be performed if the internet is not there when the test begins.
• But if the test is started, when there is an internet connection, and the connection is
dropped, as ndd device works offline, files must be stored in the result location. When
internet connection received, user must restart the laptop and get the test result.
• Follow the below mentioned steps for the same.

Page 119 of 139
Step1: Collect the spirometry form (Internet is available)
Step2: Click on “Invoke device”
Step 3: Perform the spirometry test when ndd software open (Internet is not there)
Note: NDD software must work without internet
Step 4: Click on “Finish” on ndd software

Step 5: Click on “ok” on the order file in CDDP ClinSpark portal

Page 120 of 139
Step6: Error message must display on CDDP ClinSpark portal
Step 7: Restore internet
Step 8: When user Clicked on “Invoke device”, the error message “Subject file has been
locked since: 16Jun2023 14:30. Please try again soon.” Must display on CDDP ClinSpark
portal.

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Step 9: Restart the laptop

Step 10: Login to CDDP ClinSpark portal
Step 11: Go to Data collection -> Subject
Step 12: Select the subject
Step 13: Collect the spirometry form again
Step 14: When user click on “Invoke Device” the message “Result file for this test is found,
should they be processed immediately? Clicking “No” will result in deletion” must display
on screen.
Step 15: Clicking on “Yes” will open ndd software

Page 122 of 139
Step 16: Click on “Add trial” and click on “Finish” button on ndd software.

Page 123 of 139
Step 17: Click “ok” on order file, the result must populate and click on “save and return”.

Page 124 of 139
26. General troubleshooting

The site should always contact IQVIA helpdesk with questions or technical issues related
to the device. Helpdesk number is listed under section ‘PROJECT CONTACT
INFORMATION’.
Problem Possible Cause Solution

When Easy on-PC is launched from CDDP
ClinSpark, the following error displays when
EasyOne Connect loads.
Easy On-PC
Device is not Secure USB adapter in USB
plugged into the Port and EasyOne Connect
USB Port on the Software will continue to
laptop. load test.
Upon ending EasyOne Connect session and
selecting OK on CDDP ClinSpark portal Prompt The Easy
“An order has been created. Please use OneConnect
EasyOneConnect to complete the test and then software was
press 'ok' when EasyOneConnect is closed” an closed before
error message displays: “Timeout awaiting any results were Invoke Device and perform
results. Please try again.” collected. testing.
Attempt to open another
Spirometry Collection Form
for a different timepoint or
subject, selecting Invoke
Device and closing the
EasyOne Connect session by
pressing Cancel. Then open
There is still an the original Spirometry Form
order file waiting that is to be collected and
to be performed select to Invoke the device
When Easy on-PC is launched from CDDP by the EasyOne again.
ClinSpark portal, the following error message Connect If you receive the same
displays: Software. message again, contact
Failed to initialize device. Please try again. IQVIA Helpdesk.
ClinSpark to If you receive this message,
When Easy on-PC is launched from CDDP download and attempt to close the form, and
ClinSpark portal, the following error message place this file open it again and invoke the
displays: each time you device again. If you receive it
Cannot find EasyOneConnect options file with perform a test. again, please
name “EasyOneConnectOptions.mdb” Either the contact IQVIA Helpdesk.

Page 125 of 139

directory cannot
be found, or the
files are not
present.
Quit the program and restart.

Prior to starting test in Easy One Connect Confirm there is If you receive the same
Software, you see the following Error: no airflow on the message again, contact
Self-test failed device. IQVIA Helpdesk.
When you start a test, you see the message The spirette is not Ensure that the triangle on
“Check spirette insertion”. correctly the spirometer is lined up with
positioned the triangle on the spirette
This could be the To resolve, do the following:

result of several • Ensure that the triangle on
issues: the spirometer is lined up
• The spirette with the triangle on the
is not spirette.
correctly • Use the spirette cal check
positioned. adapter provided with the
• You have not device.
used a ndd • Check the connections
adapter. and secure them during
• There are testing.
leaks in the • Ensure the syringe is
syringe pulled out entirely and
connection. pushed in entirely when
• The syringe performing the procedure.
was not • Remove or turn off all
pulled out or devices causing airflow in
pushed in the the room.
entire way. • Make sure you put the
• There is syringe in the same room
airflow in the as the device at least 30
room minutes prior to
• The syringe performing the validation
temperature calibration.
is colder or • Use the syringe provided
warmer than with the device by IQVIA.
the ambient
air.
Calibration validation outside of 3% as indicated • The specified
by “Calibration result out of range – Check setup” syringe
error during Calibration check. volume

Page 126 of 139

differs from
the actual
syringe
volume.
Steps to Resolve
1. Ensure that the user
pressed “Finish” on
the EasyOne Connect
Software
2. If EasyOne Connect
Results not imported: software is closed.
Timeout awaiting results” Have the user press
Issue Identification If the “OK” on the Timeout
1. Upon ending EasyOne Connect session finish error and invoke the
and selecting OK on CDDP ClinSpark button is device again
portal Prompt “An order has been not 3. If the results file is in
created. Please use EasyOneConnect to pressed the Results Directory
complete the test and then press 'ok' on ndd (C:\EasyOneConnect\
when EasyOneConnect is closed” an Easy On- XmlResults), when the
error message displays: “Timeout PC user invokes the
awaiting results. Please try again.” software device again,
after the ClinSpark will ask if
trial and the user wants to
user process the results.
pressed They should select
“ok” on yes. The results will
CDDP then import.
ClinSpark 4. If the results were not
Prompt in the XMLResults
“An order directory, but trials
has been have already been
created. recorded, when the
Please user invokes the
use device again, the
EasyOne software will prompt
Connect them if they want to
to add a trial or start a
complete new test. Always
the test. select to Add a Trial.

Page 127 of 139

5. If no data was
collected, they can
simply record the new
trials once the
EasyOne Connect
software opens.
1. Attempt to open
another Spirometry
Collection Form for a
different timepoint or
subject, selecting
Failed to Initialize Device:
Invoke Device and
closing the EasyOne
When I select “Invoke Device” I get an error
Connect session by
message indicating that the system failed to
pressing Cancel.
initialize the device.
Then open the original
Issue Identification
Spirometry Form that
• When Easy on-PC is launched from
is to be collected and
CDDP ClinSpark portal, the following
select to Invoke the
error message displays:
device again.
Failed to initialize device. Please try
There is 2. Navigate to
again.
still an C:\EasyOneConnect\X
• There is still an order file waiting to be
order file mlOrders and ensure
performed by the EasyOne Connect
waiting to there are no files in
Software.
be this directory. If so,
performe delete them out.
d by the 3. Attempt to Invoke
EasyOne device again
Connect
Software

Page 128 of 139

1. Contact the project
manager and data
manager for the study.
They will need to
upload a study
Invalid Set-up: configuration zip file
Getting an Error message of an Invalid Set-up including the MDB
when trying to Invoke the Spirometry Device configuration file and
Issue Identification blank database
• When the user attempts to invoke the through the
spirometry device, an error message Spirometry Upload
stating “Invalid Set-up. Study Dashboard.
Configuration is not available on S3: 2. All users are likely to
EOC_Study_Config_###.zip be receiving this error
until step 1 occurs.
This means that

a configuration
file for the study
has not been
uploaded for the
study

Page 129 of 139

1. This error occurs
because the Predicted
values for the subject
have not populated.
This can be caused by
the DOB being
Cannot save Spirometry Form: incorrect for the
subject, putting them
Value is Required error message displaying outside the reference
Issue Identification ranges
• After pressing “OK” on Upon ending 2. A demographic update
EasyOne Connect session and selecting is often required to
OK on CDDP ClinSpark portal Prompt resolve this issue.
“An order has been created. Please use Please ensure the
EasyOneConnect to complete the test user tries to press
and then press 'ok' when “Save and close” once
EasyOneConnect is closed” User cannot then press on “Form
save Spirometry Form Details” at the bottom
• Red highlights appear on the “_Predicted” of the screen. The
fields data will be stored in
ClinSpark with the
error
3. Escalate to Data
Management to
perform an Update on
the subject
demographic
information

Page 130 of 139
27. Appendix
Appendix A: Initial login and password reset

Note: New account creation will take 5 working days.
Initial Login
✓ Access CDDP ClinSpark portal at https://cddp.solutions.iqvia.com

✓ using the login credentials shared by IQVIA

Page 131 of 139
CDDP ClinSpark portal login page
✓ Change your password during the first login.
Note: CDDP ClinSpark portal has been optimized for Google Chrome.

Page 132 of 139
Password reset
✓ The 'Email Password Reset' link will become visible to you after you have failed login at
least one time.
✓ Click on Email Password Reset Link.
✓ Enter registered email ID. Select “I am not a robot” and click on Submit.
✓ User will receive email from CDDP ClinSpark portal

alerts <no-reply@clinspark.com> on registered email
ID. If you haven’t received the email, check your SPAM
folder.

Page 133 of 139
✓ Click on “Reset your password” tab. Reset password window

will open.
✓ Update your password and login to CDDP ClinSpark portal.

Page 134 of 139
Appendix B: Site training form
Protocol Number Site Number

Training Date
Principal Investigator Name
(DDMMMYYYY)
Kindly  the appropriate box
Training Type
Face 2 Face WebEx
I, the Principal Investigator/site staff, confirm that, the site is responsible for recording and uploading the
Spirometry data using <<enter name of device>> device for the above mentioned study, for which the site
staff are qualified by means of training, conducted by authorized IQVIA CD staff.
The following shall serve as a documentation of successful training of the device and system:
Training Agenda:
Spirometry Device Overview

▪ Indications, Warnings & Contraindications
▪ Kit components
▪ Device operations
▪ Preparing and educating the patient
▪ Calibration
System Overview (ClinSpark)
▪ Clinspark system access

▪ Proficiency test upload
▪ Spirometry data collection and upload process
▪ Spirometry query handling and resolution process
▪ System / Study Reports, as applicable
▪ Device Return Overview
▪ Helpdesk Support
Attendees:

Page 135 of 139
Appendix C: Equipment Receipt Checklist
You have received a package from ndd for the below study, please verify if you have
received all the items on the Equipment and Supplies Details list.
Project
Sponsor XXXXX Protocol XXXXXX XXXXXX
Manager
# Site Ship date: Country:
Equipment/Supplies Details:
Please check the box “verified by site” if you have received this item. For items with a
serial number, please check that the serial number on the checklist is matching with
the serial number of the item within your package.
Review the package for missing items. In case of any discrepancy, contact help desk.
Verified by Quipment Verified Received

Equipment item
1st 2nd by site quantity
Serial
☐ ☐ ☐ Easy On-PC
No.
Laptop
☐ ☐ ☐ Serial#
(+cable)
Thermohygrometer and
☐ ☐ ☐
Battery
☐ ☐ ☐ Spirettes
☐ ☐ ☐ 4G Modem
☐ ☐ ☐ Nose Clips
☐ ☐ ☐ Calibration adapter Piece
☐ ☐ ☐ Calibration Syringe
Envelope with Login data
☐ ☐ ☐
inside
Filters (may be attached to
☐ ☐ ☐
Spirettes)

Page 136 of 139
Appendix D: Consent form

Page 137 of 139
Appendix E: Proficiency report

Page 138 of 139
Appendix F: Quality grade
Form Name Grade
Spirometry High quality grades A, B
C, D, E, U,
Spirometry Low-quality grades
F
A, B, C, D,
Spirometry Grade_Acceptable
E
Spirometry Grade_UnacceptableAndUsable U
Spirometry Grade_UnacceptableAndUnusable F

Page 139 of 139
Appendix G: Study Activity Plan
SPIROMETRY Protocol Visit

Visit ID in IQVIA CDDP database
Recording description
1 Calibration Check Calibration Check
2 Baseline Spirometry Baseline
3 Week 9 Spirometry Week 9
6 Month 12 Spirometry Month 12
7 Poor Treatment Response Spirometry PTR
8 Early Termination Spirometry Early Termination
9 Unscheduled Spirometry Unscheduled


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Page 1 of 139

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

IQVIA Connected Devices Investigators Manual

Version # Effective Date Document Author

Version 01 23rd June 2023 Initial Document

Effective Date: 28April2023

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

2. List of abbreviations and definition of terms ................................................................. 6

3. Site staff training .............................................................................................................. 7

4. Training resources ........................................................................................................... 7

5. Receipt of equipment ....................................................................................................... 8

5.1 GENERAL SYSTEM DESCRIPTION ............................................................................................................................. 9

6.1 LIST OF CLEANING SOLUTION ............................................................................................................................ 10

8. Login to CDDP ClinSpark portal .................................................................................... 13

9. Technician certification process/Proficiency testing for technicians ........................ 15

9.1 ENROLLMENT FOR PROFICIENCY TESTING/CERTIFICATION ...................................................................................... 16

12. Race mapping ................................................................................................................. 39

13. Prepare for the test......................................................................................................... 40

13.1 SUBJECT COACHING....................................................................................................................................... 41

Effective Date: 28April2023

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

14.1 Required materials for calibration verification .............................................................. 49

15.1 Collect visit form without doing Calibration................................................................... 65

16.1 Audit trial before overreading ............................................................................................ 74

18. Report after overreading ................................................................................................ 88

18.1 Audit trial after overreading ................................................................................................ 93

20. Responding to a query and associated detail .............................................................. 98

20.1 HOW TO IDENTIFY AND RESOLVE OUTSTANDING QUERIES ...................................................................................... 98

21.1 Spirometry Value Trend Graph ........................................................................................ 104

22.1 Study subject report ........................................................................................................... 114

24. Project contact information ......................................................................................... 117

25. Internet Outage ............................................................................................................. 118

26. General troubleshooting .............................................................................................. 124

27. Appendix ...................................................................................................................... 130

APPENDIX A: INITIAL LOGIN AND PASSWORD RESET..................................................................................................... 130

Effective Date: 28April2023

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

APPENDIX B: SITE TRAINING FORM TO BE ADDED BY PM ............................................................................................. 134

Effective Date: 28April2023

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

As a part of the Gates-MRI-TBD06-201 trial, IQVIA Connected Devices will

Effective Date: 28April2023

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

2. List of abbreviations and definition of terms

ATPS Ambient temperature pressure saturated

ATS American Thoracic Society

Effective Date: 28April2023

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

3. Site staff training

• It is the responsibility of the investigator/designee to ensure the site staff conducting

Effective Date: 28April2023

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

Please contact CSSCDSupport@quintiles.com for any assistance

➢ Provisioned laptop pre-configured with NDD EasyOne Connect software and

Effective Date: 28April2023

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

5.1 General system description

5.2 Equipment replacement and / supply re-order

Please contact CSSCDSupport@quintiles.com for any assistance

Effective Date: 28April2023

IQVIA Connected Devices Investigators Manual – Easy on PC Spirometry

6. Cleaning & hygiene instructions

6.1 List of cleaning solution