CDM Interview Q&A

Screening (folder / visit)

Demog - (eCRF / Form)

DOB
AGE
SEX
Pregnancy potential
Race
Ethnicity

ALS

eCRF specification - TD / LCDM

Rave
Architect
DEV
UAT
PROD

DYNAMIC checks

START UP SUMMARY

Management will identify the Lead CDM

Protocol
Budget details - draft (if any activity is not listed in the Budget - Out of
scope)

Team list -
Request for creating share drive folders

eCRF design
eCRF specification
Visits/folder
Forms (assessments, procedures
Fields -

Once eCRF specs are drafted - shared for internal and external
review
Kick off Meeting - to finalize the eCRF specification document
Approve the eCRF specs - signed

Create the eCRF design (Rave - as EDC - architect)

eCRF PDFs
TD will share the design for internal and external review
eCRF design kick off meeting - TD will take you through the
design of your study (Online Screen Review Meeting - OSRM)
Team - will give comments

Share the final eCRF design - signed and approved

Unique eCRF PDF 82

All Visit eCRF PDF
Annotated eCRF PDF
Edit check specification
Dynamic checks -
Continuation form
Will subject participate in next visit (yes / No)

Derivation checks
Subject enrollment form
Site number 101
Subject unique 1001
Subject ID 101-1001

Unscheduled 12-Jan-2021
Unscheduled 16-Feb-2021

eMail Alert checks

Applicable ONLY for SAE

Clinical checks
ANS: Missing data fields, comparison checks(AESTDT is
Not Empty, but AEENDT and AEONGO are EMPTY), AEOUT Is Equal
To FATAL, and Death/Study Discontinuation form is Empty.

ECS - approved and signed

Move to PROGRAMING and TEST case writing

Default checks

Range check
NC check
IsRequired check
 Future date

9343

9344

After partial Go Live I

Working on the rest of the start up activities.

88 failed - 9344

GO Live II

Programming of edit checks - Rave programmers

Test cases - DM team

500-1000 checks - Allocation - best practices - HOW ?

Form wise allocation
Experience wise allocation
Assign a range of subject to each associate
Bhi- 1001-1999
Swati - 2001-2999

Check # 1 - Date of visit should not be prior to Screening visit

DOV - 5-Mar-2021
Screening - 10-Mar-2021

Test case
Check Subject # Test case Result UAT 1
#/logic
Check 1 1001 - Dirty
data
Screening DOV = 10-Jan-2021
DOV Day1 = 9-Jan-2021 Query Pass
(Test for all visits)
expected
Screening DOV = 10-Jan-2021
DOV Day1 = 10-Jan-2021 Query not Fail
(Test for all visits)
expected
1001- Clean Screening DOV = 10-Jan-2021
DOV Day1 = 11-Jan-2021 No Q E pass
(Test for all visits)

UAT - it will start once all checks are programmed and test cases are
ready

UAT round 1

Creation of UAT PLAN - 9343

Atual UAT - testing of checks for their accuracy.

500 - test cases are ready.

100 checks to 5 candidate each -

Find list down all FAILED checks and their reasons - 88 fails

UAT REPORT

Programing team will re-work on failed checks - 88

DM team - create / check the test case of failed checks

UAT round 2 - 9344

88 checks will be tested and if we have 10 failed checks we will go to

Round 3

UAT round 3 - 9345 ALL checks are passed

Get ready for Go-Live - push 9345 version to PROD

PUSH TO PROD form -

GO-LIVE

DMP
CCG
Go-Live

Split GO live
CONDUCT activities

Data Review - Page status report

SDV
DM review
Freezing - entry locked
Hard Lock

Open query is present or not

Answered query is present or not

Query M
Report - Query Detail Report
Open
Answered
Closed
Canceled

Query Management -

Coding

SAE recon

Subject ID
AE term VBT
AE Preferred term
AE start date
AE end date
Outcome
Reason for seriousness
Grade
Relationship with drug 1
 Relationship with drug 2
Demog information - Age/DOB and Sex

Process
Create an SAE recon plan
Get the Safety file and clinical file

Identify the issue

Raise query in EDC
Based on sites response, identify the issues in safety file

SAE reconciliation log

Study ID Subject SAE Start End Issue /

iD term date date comme
nt

IVR data and recon

Vendor Recon

Vendor plan / DTA

LB (chem, hemato, Urine)

PK
PD
ECG
Serology
Serum

Subject ID
Visit name / Date / time
Collection of sample - Yes / No
Sample collection date / time
Accession number / Requisition No
PK / ECG - time points

Vendor reconciliation log

Rahul Bhimanna
predose 9:50 10:45
0 10 am 11 am
15 10:15 11:15
30

Predose (15)
0 hr
15 min
30 min
1 hr
2 hr
4
8
12
24
48
 Data transfers

Metrics
Query M
Page status M
Subject status M -
SF
Randomized
On Treatment
EW / WC
Follow up
Completer
Total

SAE status
Vendor Status
Coding details
SAS checks review
Protocol Deviation

Non-EDC edit checks / DVS / Backend checks (Programmed /

Manually) - SAS

SAS programer - output for review

50 - 100 - Mar - 90 queries (60) - Add comments

April - 130 -

Complex checks
Checks missed out in the ECS
 SAE recon checks
Lab checks
ECG checks
SAS listings

Medical Review listings

DM, MH, AE, CM, DS (SF, Drug withdrawal and study
withdrawal),
LB files
VS and PE

Meetings / MOM
Availability of team members
Agenda
MoM

PPC / Migration / change control -

Reasons - Protocol Amendment
Issues in the EDC after go live
Misfiring checks,
Updating the study design

Plan it, update your PP and timeline for same

Change control Log -

list all possible changes/updates in study design
Checks which needs to be added / inactivated
Misfiring checks, if any

Document preparation
Protocol deviation -

Types of PDs
IE creterias
Dosage and administration
Procedural PDs
Withdrawal criteria PDs
Prohibited medications

RECIST - Response Evaluation Criteria in Solid Tumors

Set of Published Guidelines that permits the assessment of
changes in the tumor
Why ? - to standardize the process of evaluation

Types of Lesions - Target Lesion

Non- Target Lesion

Measurable - longest diameter of tumor if minimum of 10 mm by CT

X-Ray - 20mm

and Non-Measurable - Longest Diameter - less than 10 MM

Target Lesion Non-Target Lesion

Complete Response (CR)
Disappearance of target lesion
Partial Response (PR) - 30%
decrease in the Sum of diameter
of target lesion
Stable disease - (SD) - No
sufficient shinkage nor sufficient
CR - Disappearance of all non
target lesion
Non-CR/ Non-PD - Persistence of
one or more NT Lesion -
Maintenance of NT Lesion
increase in the size of SoD of TL
Progressive Disease (PD) - At Progressive Disease (PD) -
least a 20% increase in the SoD Unequivocal progression of
of TL existing NT lesion

The appearance of one or more

new lesions

Evaluation of Overall Response

Target lesion Non-Target New Lesion Overall

Lesion Response
CR CR No CR
CR Non-CR/Non-PD No PR
CR Not evaluated No PR
PR Non-CR/Non-PD No PR
SD Non-CR/Non-PD No SD
PD Any No / Yes PD
Any PD Yes / No PD
Any Any Yes PD

Close Out Phase

LSLV - Last Subject Last Visit.

2-3 months

1 Apr
10 - Jun - DB lock

DB lock meeting - plan DB lock activities.

PP - for lock activities

In PP
Date for last data entry - 20 - Apr

Last Query out date - 20-May

Last Query Resolution date - 30- May

Close out activities/checklist -

All data entered

All SDV done

All SAE reconciled

All vendor data reconciled
All SAS checks reviewed
Final MR done
Coding should be completed
Protocol deviation review - completed

All queries closed

DMR completed

PI signatures (DM DE access - release the casebook for PI sig)

Freezing (Data Entry lock)

Lock
 Final extracts for data analysis - through SDTM datasets

DB lock form - sign and approved by LDM and Sponsor

Study decommissioning - Revoking of study accesses

Archival - all data is transferred in CD’s and shared with client

Study Start-up Questions:

1.What is your experience in Study Start up Activities?

ANS: Reviewing the protocol, annotated-CRF, communicating with programmers
and testing eCRFS programmed and preparing eCRF specs and DVS and
involved in preparing the test scripts for UAT.
-SOP
- Data management plan
- CRF annotation
- Database build and design / global library/CDISC,SDTM,CRT-DDS
- Edit check
- Workflow process documentation
Test cases
- User Acceptance testing
- Case report form completion guidelines document

2.Experience with eCRF spec and Edit Check specification? Explain it in detail?
ANS: eCRF spec we provide the details for building CRFs in EDC along with
annotations and conditions(dynamic checks) for getting forms in different visits
which we prepare in Date_Visit_Form Matrix, from protocol. And DVS, all the
possible checks are programmed inorder to get clean data at the data entry time
and also the different possibilities of cross functional form checks.
Edit check specification list
Identify field for edit checks
Draft ECS document

3.Experience with UAT?

ANS: Test scripts are written for checks, with both clean and dirty data, for
testing to make the data clean and maintain a UAT log for communication with
programmers.
- Preparing UST test plan
- Test cases - data entry
- Creation of UAT closure report
- UAT CAN Happen in multiple rounds

4.Have you written CCG?

ANS: Yes, for every field expected data format has been mentioned, the type and
length of the data. And explaining the options provided for Data entry(like
checkboxes, drop down)

5.If you are building a Database, are you having any timelines?
ANS: Yes, generally like for eCRFs building for an entire study we would be
given a week time in which we need to build, test and get ready for UAT. and for
edit checks around 2-3 weeks depending on the number of edit checks and also
on the number of CFs(custom functions) that need to be programmed.
ANS: YES, generally 2-3 months and it depends on the complexity of the study.

6. What do you include in DMP?

ANS: A DMP should touch on all the elements of the Data management process
lik eCRF Creation, database design and build,edit check specifications,study
database testing and release,data or paper flow,reports and metrics,query
Management, Managing lab data,coding reported terms,Handling SAEs,
Transferring data,Study database lock.
All the steps to be taken if any protocol amendments are done, and also the point
of contact for escalation in case of study issues, and also the SOPs for all the
activities done.

Study Conduct Questions:

1.When are DCFs used? And how the data will be handled after they are answered
by the sites?
ANS: DCFs are Data Clarification Forms, used generally for Paper studies for
sending queries to sites, requesting clarification of certain data(sending queries
in forms)

2.How the study metrics are generated?

ANS: Study metrics is an excel report prepared weekly/bi-weekly, depending
upon the study standards, describing, current status of the study. It gives the
picture of the study by giving the details like subject status, query status, SAE
reconciliation status, 3rd party and vendor data reconciliation status, missing
pages status. Metrics are generated by Lead CDM and reported to the sponsor
and also will be informed to the team.

3.Are SAE Reconciliation Logs generated by the SAS team?

ANS: It differs from company-company, Manual reconciliation, auto-reconciliation
are done(Internal Tools) in general. In some, SAS programs are written for
reconciliations.
4.Experience with Post Production changes(Migration)/Protocol Amendments?
ANS: During trial, if any changes have been made to protocol, those to be
implemented in study, for which DB needs to be updated. changes are discussed
with the CST team, and communicated to programmers and testing the final
output before moving into prod. And after migrating the existing subjects into the
latest CRF version or DB, Reports are taken and studied for the expected
changes(Also done before moving into PROD, for Impact analysis) .EX: Query
has been removed in the new version, so the query raised in old subjects should
not be visible now.
5.What activities are you responsible for in Study conduct?
Study conduct begins once the subject is enrolled and the trial data collection
begins. Data cleaning
● Data Review
● Query M
● Coding
● SAE recon
● IVR data and recon
● Vendor Recon
○ Data transfers
● Metrics
● Non-EDC edit checks / SAS checks (Programmed / Manually)
● Medical Review listings
● Meetings / MOM
● PPC / Migration / change control - due to Protocol Amendment
● Document preparation
● Protocol deviation

6.Have you written(involved in preparing) Manual Listing Specification? What are

the points you consider for preparing it?

7.Protocol deviation? What will you do?

It is failure to adhere to IRB approved protocol
Protocol Deviation can be Minor and Major
Minor Deviation- are administrative and do not affect patient safety/rights and
data
eg- lost original consent form
Major Deviation- any deviation that effects patient safety/rights and data integrity
eg-not obtaining informed consent
Whenever there is a protocol deviation, fill out the PD form and send it to the
sponsor and also let the CRA know about it and when applicable send the form to
IRB.
If they are repeated deviations- then we need to re-train the staff or do draft
amendments or both of them.
???Is it necessary to obtain IRB approval for every protocol amendment before
deploying the updates to the database?

8.Did you do any kind of Reconciliations?

ANS: Yes, SAE recon, Vendor Recon, Third Party Recon.

9. Why do we need Reconciliation?

ANS: To ensure the same data collected in different databases are matching.
As same data is being entered in different databases at different times, For
ensuring Data quality and completeness, reconciliation is required.

10.How will you review(manual) the data? What are the specs you use for it? Will
it be done as per Data review Plan?
ANS: As its main aspect is to maintain the quality data, its done in different
steps in different stages of the trial. It can be done through programming edit
checks during the study startup, so that at the entry time itself, data errors can be
resolved, then by system checks, next by query management process where the
raised system queries are worked on, and new queries can be raised as per the
data entered, next by SAS checks/non-EDC checks, the data review is done by
going through these SAS outputs and manually queries dazed at particular data
points, SAS checks can be used for diff types of scenarios like complex checks
and comparing EDC with Non-EDC data. And also SDV and Data review done at
field level also included in Data Review process. Data Review also includes
reviewing the study status by going through different reports like Page status
reports
(checking on Query status and DE status) or different listings . DRP includes all
the above steps which will be planned in the study start-up.
We use SAS listings report/log for manual review of data.

11.Where will we raise the queries regarding missing pages?

ANS: Missing pages are those eCRF pages, for which data entry has not been
done, their tracking is done through Page status Report, and subsequent queries
will be raised by DM to Site.

Study Close-out Questions:,

1.What activities will you do in closeout?

ANS: closeout activities check-list–
Page status report tracking(data entered, not entered, missing pages)
Query status
Final data review and coding and reconcil status
SDV
Freeze
lock
PI Signature
Database transfer
Electronic archival

General Questions:

1. Start with talking about yourself? Walk through your experience?

2. Were you the supporting data manager to lead Data Manager in your journey?
3. Talk about your Resume?
4. Current Roles in recent company? Explain? How many studies have you
handled? Which phase? What stage were those studies in?
5. Experience with Global Standards Team?
6. Experience in running meetings with CST(Clinical Study Team) and with
Vendors?
7. Experience with oncology and Cardiovascular Study?
8. Have you written DTA/DTS(Data Transfer Specification) and what do you
include in it? And when we do we prepare this document, at which stage of
trial?
Yes, DTA defines the format of files, frequency of data transfer, file naming
conventions, encryption levels, method of transfer, type of transfer(complete vs
partial), recipient test names,formats,high and low value flags or alerts.
9. What other functions/groups have you interacted with in day-to-day life as
CDM?
ANS: SAS, Statisticians, medical monitor, Safety team, PI, CRA.

10. What kind of external data did you work with?

ANS: Central lab data, IVRS.

11. How do you handle IxRS/IVRS/ePRO data?

IVRS- is used by the sites to screen subjects,to randomize subjects and to
assign investigational products
IVRS data communicate with the EDC system so there’s no need for
duplicate data entry or data reconciliation
Study managers have access to automated system reports for real time
information about the trial
The coordinator, PI,CRA have access to this data
12. Any Experience where you Work with outsource somebody with a different
company? where you maintain oversight of work?
13. What are the activities you were seeking with CRO? What were they doing for
you and what were you doing oversight on?
14. What Therapeutic Area have you worked on?
a.What are the study specific forms which you built? Or worked on?
ANS: Oncology, Immunology, Ophthalmology.

15.How many studies have you had as a Data manager?

16.Were you involved doing timeline for data management or it was given by
project manager?
17. Have you used MS-Project?
18.What do you think of Biomarker?
It is an objective measure that captures what is happening in a cell or an
organism at a given moment.

19.Did you have any Stressful Situation in your Job where you were under
Pressure to deliver?
ANS: Last minute changes to protocol before moving into production or missed
any CRFs programming or testing. Personal experience of adding an extra form
of vital signs and writing ECs for them, and UAT in stringent timelines.

20.Did you have to negotiate with timelines given to you?

21.What is your experience with CDASH?
ANS; Standards used for maintaining uniformity in the CRFs design in the form of
annotations, like Variable OID or Field OID, given basing on CDASH, used in
back-end mainly for SAS during analysis of the study output.

22.Have you Participated in a Sponsor Team Meeting?

a. Who will attend the meeting?
23.What is the timeline for building Database to Going live?
ANS: 2-3months depending upon study

24.Tell me how you organize, plan, and prioritize your work when dealing with
multiple studies which are at different stages.
25.Share an effective approach in working with a large amount of data.
26.Are you involved in preparing a safety management plan/Data Integrity
protection plan/Statistical analysis plan?
Vendor or Client Initial round of Questions:

1)Tell me about your experience or introduce yourself.

2)Explain about CRO and give me one example
3)CRO/ vendor oversight activities
4)How do you work or manage vendors?
5)How do you deal with problems from vendors during oversight?
6) How many Therapeutic areas you worked on?
7)Years of experience in oncology and other studies?
8) Tell me about Oncology and Cardio?
9) How many Phases you worked on recent Project?
10) What is your current Visa Status and on which visa status you came to US?
11) When did you came to US?
12)Bachelors and Master Years?
13)What are the EDC database you have used?
14)EDC systems worked on and for how many years?
15)Experience with study build and lock in Rave?
16)What is the reason you leave the clients?
17)How many projects you have worked as a Lead data manager
18)Would you prefer working more with CROs or Pharma Company?
19)UAT Process?
20)SAE reconciliation activities
21)Tell me about serious adverse event reconciliation
22)About edit check specifications?
23)how many database locks have you performed and describe how you do database
lock?
24)Study Set up process
25)How to you do study start-up.
26) How do you help in building the study?
27)How many study start-ups as a lead?
28)How long for initiating study start-ups?
29) Role in documents for study start-ups?
30)Who do you interact in the study team?
31)How did you manage working with your team and how did you made all the things
work from start-up
to closeout?
32)What are the steps involved in building of the study?
33)Tell me about your experience with study conduct?
34)Study closure activities
35)Do you have any hands-on experience with preparation of study data documents?
36) Tell me more about data cleaning.
37)You have mention SAS in your resume would you explain what experience you have
with SAS programming?38)Have you worked with SAS? Can you write test scripts?
39)How do you work with biostatisticians and programmers?
40)How many members did you lead or how many members are there in your team? And
what’s your
experience managing large teams.
41)Role in meetings?
42)Have you done any presentations? whether with sponsors or CRO?
43)How do you manage tight timelines?
44)How many projects did you handle?
45)Conflicts cross-functionally?
46)Microsoft project if used?
47) How do you manage global meetings or work?
48)Tell me a situation where you have to stop and think to proceed?
49)tell me the situation where you performed demanding task as lead cdm
50)tell me the situation on how you overcome with the nearby timelines
51)What are the challenges you faced with Sponsors?
52)situation when you have impressed the Sponsor with Quality of work.
53)Are you involved in creating documents and how did you meet the timelines?
54)How did you take care of that when there is complaint from sponsor for missing in
quality in review?
55)Tell me about handling conflicts internally?
56)What do you think work from home has improved your capacity, how?