Protocol Id Gates-MRI-TBD06-201, Visit Code Poster - Version 01 - 16th May 20231

IQVIA Connected Devices - Visit Code Poster Page 1 of 7
Demographic Data Entry Instructions & Visit Schedule for

Gates-MRI-TBD06-201
Document Version History:
Version # Effective Date Significant Changes
Version 01 16th May 2023 Initial document
The site users will be provided access to Gates-MRI-TBD06-201_ Proficiency testing database
first. Once the flat line TEST ECG is uploaded, the site users will be granted access to LIVE
database ie Gates-MRI-TBD06-201 database.
All Flat Line TEST ECGs should be recorded and uploaded in Gates-MRI-TBD06-201_
Proficiency testing database and LIVE ECGs should be recorded and uploaded in Gates-MRI-
TBD06-201 database.
Prior to ECG collection for each new subject, the subject should be enrolled in IQVIA CD
ClinSpark study portal.
Perform the following steps to enroll a new subject:

 Select the appropriate study from the dropdown on the top of the page.
 Locate and select menu option “Subject” under “Data Collection”. The “Subject Search” page
will open.
 Click ‘Enroll’
Protocol id Gates-MRI-TBD06-201, Visit Code Poster _ Version 01_ 16th May 2023
Template No.: CS_TP_CND0112 Revision 4 Reference: CS_OP_CND0010
Effective Date: 15May2023

Copyright © 2021, 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.
 “Enroll Subject” page opens which allows the site staff to enter the following subject
demographic information:
 Sex – Select Male or Female
 DOB in 01/Jul/Actual year format
 Screening number: Enter the 8-digit subject Screening number (i.e., 11010001))
 View the screenshot below for entering the subject demographic information

 Verify subject demographics and then click ‘Save’

NOTE: Prior to clicking "Save" verify the subject demographics are correct. Once subject
details are saved it cannot be edited on the ClinSpark study portal or used for any other
subject in the study. In cases of any incorrect entry, please notify the IQVIA CD helpdesk
team so that a data query (DCF) can be raised to correct the ClinSpark portal and IQVIA CD
ECG database.
 Enrolled subject will be saved, and you will be directed to the ‘Data Collection’ page.
 Below message ‘’The subject has been saved’’ appears on the screen:
 The subject is now ready for data collection across all visits (Study Events). A sample
screenshot below for reference

Visit codes (Study Events) for Gates-MRI-TBD06-201
Stage 1
(Triplicates ECGs to be recorded at each time point)
Actual Study Visit Visit Code to be selected from the Study

Event Form
Screening Day -10 to -2 ECG Screening
Week 2 ECG Week 2
Week 4 ECG Week 4
Week 9 ECG Week 9
Week 13 ECG Week 13
Week 17 ECG Week 17
Week 21 ECG Week 21
Week 26 ECG Week 26
Month 12 ECG Month 12
Early Termination Visit ECG Early Termination
Unscheduled ECG Unscheduled
Stage 2
(Triplicates ECGs to be recorded at each time point)
Actual Study Visit Visit Code to be selected from the Study

Event Form
Screening Day -10 to -2 ECG Screening
Week 2 ECG Week 2
Week 4 ECG Week 4
Week 9 ECG Week 9
Week 11 ECG Week 11

Week 13 ECG Week 13

Week 15 ECG Week 15
Week 17 ECG Week 17
Week 21 ECG Week 21
Week 26 ECG Week 26
Poor Treatment Response Visit ECG PTR
Early Termination Visit ECG Early Termination Visit
Unscheduled ECG Unscheduled
NOTE
 The ECG waveforms from ClinSpark study portal can be used for immediate subject
management by investigator.
 The complete ECG interpretation provided by the IQVIA CD Cardiologist will be available and
notifications of results will be emailed back to the site within 1 working day (excluding Sundays,
holidays or time spent resolving queries).
 The ECG report generated by IQVIA CD includes measurements and comprehensive

interpretation along with the subject demographics but DOES NOT contain the ECG waveform
itself.
 The investigator may contact study CRA/IQVIA CD if he/she disagrees with the IQVIA CD
report
 The ECG waveform printed from the ClinSpark study portal and the IQVIA CD ECG report
should be filed in the subject files.
 The investigator or medical designee must review the ECG waveform and IQVIA CD ECG
report. It is highly recommended that the investigator documents this review by signing and
dating each report.
 If there are differences in the ECG interpretation between the investigator and IQVIA CD, the
investigator’s interpretation will be considered for study eligibility criteria and safety assessment
of the subject and IQVIA CD interpretation will be considered for data analysis purposes.

 IMPORTANT: It is possible that for a few ECGs the site will receive an interim ECG report
followed by a final ECG report once the senior cardiologist has reviewed and signed off the
ECG report.
 IMPORTANT: It is possible that during the study there could be amendments to a few ECG
reports for either one of the following reasons:
 Demographic information: In the event of resolution of a DCF, either of the following

items could be amended on the ECG Report
o Screening/subject Number
o Date of Birth
o ECG Date
o ECG Time
o Gender
o Visit Code
 ECG Parameters and Interpretation: During the review of ECGs as a part of our quality
control process, it is possible that few ECGs could be amended for their parameters,
diagnosis, or overall interpretation. The amended ECG report will bear the “Amendment
report” stamp on it and shall be faxed/emailed to your site along with a covering letter. It is
the responsibility of the Principal Investigator to review the amended report to make a
clinical assessment and file the report in the relevant subject records.
 In all cases, a complete ECG interpretation will be made, and the result will be reported to site
by fax/email within the agreed turnaround time.


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IQVIA Connected Devices - Visit Code Poster Page 1 of 7

Demographic Data Entry Instructions & Visit Schedule for

Document Version History:

Version # Effective Date Significant Changes

Version 01 16th May 2023 Initial document

Perform the following steps to enroll a new subject:

Template No.: CS_TP_CND0112 Revision 4 Reference: CS_OP_CND0010

Effective Date: 15May2023

Template No.: CS_TP_CND0112 Revision 4 Reference: CS_OP_CND0010

Effective Date: 15May2023

 Verify subject demographics and then click ‘Save’

Template No.: CS_TP_CND0112 Revision 4 Reference: CS_OP_CND0010

Effective Date: 15May2023

Template No.: CS_TP_CND0112 Revision 4 Reference: CS_OP_CND0010

Effective Date: 15May2023

Visit codes (Study Events) for Gates-MRI-TBD06-201

Actual Study Visit Visit Code to be selected from the Study

Actual Study Visit Visit Code to be selected from the Study

Template No.: CS_TP_CND0112 Revision 4 Reference: CS_OP_CND0010

Effective Date: 15May2023

Week 13 ECG Week 13

 The ECG report generated by IQVIA CD includes measurements and comprehensive

Template No.: CS_TP_CND0112 Revision 4 Reference: CS_OP_CND0010

Effective Date: 15May2023

 Demographic information: In the event of resolution of a DCF, either of the following

Template No.: CS_TP_CND0112 Revision 4 Reference: CS_OP_CND0010

Effective Date: 15May2023

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