Gates MRI-TBD06-201 - Investigator ECG Manual Version 01 - 16th May 20232

IQVIA Connected Devices Investigators Manual for ClinSpark RScribe
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Investigator ClinSpark RScribe Manual for the

12-Lead Resting Electrocardiograph
Protocol: Gates-MRI-TBD06-201
Document Version History:
Version # Effective Date Significant Changes
Version 01 16th May 2023 Initial Version
Table of Contents
Table of Contents............................................................................................................................2
Protocol id Gates-MRI-TBD06-201, Investigators Manual Version 01_ 16th May 2023
Template No.: CS_TP_CND0143 Revision 1 Reference: CS_OP_CND0010
Effective Date: 16Jul2021

Copyright © 2021 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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1. INTRODUCTION.......................................................................................................................4
BEFORE YOUR FIRST SUBJECT....................................................................................................................................................6

REVIEW TRAINING MATERIALS...................................................................................................................................................6
Check AM12 lead cable, the study laptop and internet connectivity...............................................................................6
Collect a test ECG............................................................................................................................................................ 6
2. CLINSPARK STUDY PORTAL................................................................................................7
STUDY DASHBOARD, STUDY DATA AND REPORT............................................................................................................................8

ENROLL NEW SUBJECT FOR DATA COLLECTION..............................................................................................................................9
SEARCH FOR EXISTING SUBJECT...............................................................................................................................................12
3. SUBJECT PREPARATION AND HOOK-UP..........................................................................13
SKIN PREPARATION...............................................................................................................................................................13
Steps for good skin preparation:...................................................................................................................................13
ELECTRODE PLACEMENT........................................................................................................................................................ 13
4. COLLECT SUBJECT ECG.....................................................................................................15
5. RECORDING REPEAT ECG..................................................................................................24
6. STUDY DATA AND ECG REVIEW........................................................................................28
STUDY DATA....................................................................................................................................................................... 28
7. OFFLINE MODE OF ECG COLLECTION (BACKUP)...........................................................30
REPEAT VISIT (OFFLINE MODE)............................................................................................................................................35

8. RECEIVING ECG REPORT FROM IQVIA CD.......................................................................36
ECG Review and Analysis...............................................................................................................................................36

ECG REPORTING.................................................................................................................................................................. 36
DATA CLARIFICATION (QUERY) PROCESS...................................................................................................................................38
CARDIAC SAFETY WEB PORTAL THROUGH IQVIA INFOSARIO.........................................................................................................39
9. ORDERING SUPPLIES AND RETURNING ECG EQUIPMENT........................................40
10. PROJECT CONTACT INFORMATION..............................................................................41
11. TROUBLESHOOTING........................................................................................................43
Wandering baseline: wavy or unstable baseline...........................................................................................................43

CLINSPARK STUDY PORTAL RELATED TROUBLESHOOTING..............................................................................................................44
12. APPENDICES.....................................................................................................................45
APPENDIX A: RESET PASSWORD IN IQVIA CLINSPARK SYSTEM.....................................................................................................46

APPENDIX B: SAMPLE ECG REPORT.........................................................................................................................................49

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APPENDIX C: SAMPLE DCF TEMPLATE......................................................................................................................................50

APPENDIX D: WEB PORTAL....................................................................................................................................................52
APPENDIX E: LIST OF ABBREVIATIONS COMMONLY USED IN ECG REPORTS....................................................................................57

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INTRODUCTION
IQVIA Connected Devices (IQVIA CD) provides centralized ECG monitoring services for
pharmaceutical clinical trials. Using our central ECG service, multi-center, international clinical
trials can benefit from complete control of the reporting format, as well as the investigators
benefit from high-precision measurements and accurate interpretation of the ECGs, facilitating
the important clinical decisions along with the ease of recording and transmitting ECGs round
the clock.
For the Gates MRI-TBD06-201 study, you will be using the IQVIA CD provided AM12 lead cable
& the study laptop installed with RScribe Lite ECG data collection software and ClinSpark Agent.
Using the ClinSpark application interface, 10-second ECGs can be digitally collected, viewed,
and automatically transferred to the IQVIA CD core lab ECG database. At IQVIA CD core lab,
the ECGs undergo thorough review and approval by Cardiologists. The ECG reports are then
emailed to the investigator site within the agreed upon timelines. To meet the stringent demands
of the regulatory authorities, a robust and systematic methodology is used during all ECG
handling processes.
This Investigator ECG Manual provides standardized instructions to site staff associated with
this study. It is important that all the staff responsible for collection, review and transmission of
ECGs, reviews this manual and becomes familiar with these instructions and processes
employed at IQVIA CD for this study.
The initial study kit will be shipped to the sites prior to Site Initiation Visit which will contain the
following:
 AM12 lead cable
 Study laptop installed with following ECG software:
1) RScribe Lite (the ECG data collection software)
2) ClinSpark Agent (the interface between the RScribe Lite and ClinSpark application)
 Laptop Charger
 Log-in credentials for the laptop (Laptop user ID will be frozen, i.e. user will not have to
enter the User ID; only password needs to be entered which will be provided
separately with laptop)
 Electrodes
 Investigators ECG Manual
 Toll free phone numbers for 24×7 multilingual IQVIA CD helpdesk support
*The Username, Password and link for accessing ClinSpark study portal will be sent separately
via email from the IQVIA CD Project Manager or representative.

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Additional electrodes can be ordered if needed during the study conduct by

following the steps in mentioned in section ORDERING SUPPLIES AND
RETURNING ECG EQUIPMENTof this manual.
We are pleased to be a part of this trial and look forward to working with you and your site.
Before your first subject

Please complete the procedures mentioned below upon receipt of your start-up kit.
Note: Please ensure to follow the procedures mentioned below prior to collecting your first
subject ECG.
 Review training materials

As the staff responsible for recording, review and transfer of ECGs to IQVIA CD, please review
this investigator manual thoroughly to understand the process for ECG collection, review and
automated transfer process via the ClinSpark study portal.
It is responsibility of the Principal Investigator to ensure the site staff conducting the study
is/are trained on ECG requisites before performing any trial activities on the IQVIA CD
ClinSpark system. IQVIA CD will not track training completion or documentation at site. This
should be documented in the Site Training Log.
NOTE:
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.
 Check AM12 lead cable, the study laptop and internet connectivity
Upon receipt of the study kit, check for any damage and verify proper connection of the AM12
lead cable to the study laptop by collecting a test ECG as mentioned below. If you have any
problem or any questions, please call the IQVIA CD helpdesk so that it may be addressed.
Please login into the laptop with the login credentials provided (with the laptop in the study kit).
Please ensure the study laptop is connected to Wi-Fi/LAN and connectivity is established.

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 Collect a test ECG

Upon completion of the ClinSpark training and review of this Investigators ECG Manual (and
before the first subject screening), site is required to record a Flat line TEST ECG and transfer
it to IQVIA CD by accessing ClinSpark study portal ie Gates-MRI-TBD06-201_Proficiency

testing. You can create a test subject as <SITE ID + 999 > and perform the test ECG data
collection by following steps in section Collect subject ECG.
NOTE: The login credentials will be shared via email to the user provided to IQVIA CD. The user
should ensure to login into the ClinSpark portal 10 days prior to their first subject visit. This will
ensure any issues/concerns can be addressed in a timely manner with the IQVIA CD helpdesk
support. Upon first login, the user will be prompted to reset the password.
If you have any problems in accessing, collecting and/or reviewing flat line TEST ECG in the
ClinSpark study portal ie Gates-MRI-TBD06-201_Proficiency testing, please bring it to IQVIA
CD helpdesk’s attention immediately by calling the toll-free number, so that it can be addressed
in a timely manner.

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2. CLINSPARK STUDY PORTAL

Once you have verified the ECG kit, confirmed the internet connectivity and reviewed the
training materials, you should login to the IQVIA CD provisioned laptop and access
ClinSpark study portal at https://iqvia.ClinSpark.com/login, using the login credential
shared by IQVIA CD.
 Please refer to email received from css_am@iqvia.com to obtain the link as well as
your first-time user credentials for IQVIA ClinSpark system
 If you haven’t received the email check your SPAM folder
 Use Google Chrome only
 Change your password during the first 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: Reset Password of this manual for detailed instructions
for changing the password. Please contact IQVIA CD helpdesk for further assistance.

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Study dashboard, study data and report

Once you login into ClinSpark study portal ie Gates-MRI-TBD06-201, you will be directed to the
study ‘Dashboard’ page. On the top of the ‘Dashboard’ page users will see a dropdown to select
the study based on participation and access.
NOTE: If multiple studies are programmed, please ensure to select the correct study
from the dropdown before proceeding with any activities on the ClinSpark study portal.
The dashboard feature allows for review of study progress and status. The dashboard will
provide overall % of ECGs completed and incomplete (i.e. not done) as shown below.
IQVIA CD has a separate ‘Data Clarification Process’ as described in Section Data Clarification
(Query) Process of the manual, thus study query details will not appear in ClinSpark study
portal.
The list of ECGs collected, pending for collection and ECG PDFs can be viewed at any given
time under ‘Study Data’ and ‘Report’ tabs.
Please refer to Section ClinSpark study data and ECG review of this manual for detailed
instructions for accessing the ‘Study Data’ and ‘Reports’ tabs.

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Enroll new subject for data collection
Prior to ECG collection for each new subject, the subject should be enrolled in 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’.
 “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

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 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

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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

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Search for existing subject

The ClinSpark study portal allows you to search for already enrolled subjects for easy access.
Once the subject is already enrolled, you will not be required to enter subject demographic
information for every ECG collection. Perform the following steps to search for already enrolled
subject.
 Click on ‘Data Collection’ – ‘Subject’
 Lists of already enrolled subjects can be seen by clicking on ‘Study Subjects’ drop down or
by typing the subject number in ‘Study Subjects’ field
 Select the already enrolled subject for data collection
NOTE: If a subject is not listed in the dropdown, it indicates that the subject is not enrolled
in the ClinSpark portal. Kindly follow the steps to add and enroll the subject outlined in
section Enroll new subject for data collection.

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3. SUBJECT PREPARATION AND HOOK-UP

Careful preparation of the subject and proper application of electrodes is the key to a good quality
ECG recording. It is important that the subject is calm, relaxed, and in supine position before the
electrodes are applied. Subject should remain supine for at least 5 minutes prior to hook-up and
should be still during the ECG recording.
Note: The recommended position for an ECG recording is the supine position. However, in
situations where the subject cannot be in supine position, ECG can be recorded in the
sitting position with usual standard placement of the electrodes.
Skin preparation
Steps for good skin preparation:
 Have subject remove all clothing and jewelry from waist up
 Always cleanse the electrode site well with an alcohol pad, dry with a gauze pad; repeat if
necessary (The attachment site should be free of any lotions, perfumes, or moisture)
 Shave hair at the site of electrode placement if necessary; the electrode should adhere
directly to the subject’s skin
 When reapplying electrodes, ensure any gel residue is removed and electrodes changed.
 Electrodes should always be kept in an air-tight container
NOTE: Good skin preparation prior to electrode attachment is important to ensure high
quality when recording the subject ECG. Poor skin-electrode contact may cause noise, or
artifact, to be included in the recording. Poor skin contact may also result in low
amplitude waves.
Electrode placement
Place the electrodes avoiding large muscle masses, to achieve better tracing quality. The
placement of electrodes should be completed as described below.
RL - On right leg (inside calf, midway between ankle and calf muscle)
LL - On left leg (inside calf, midway between ankle and calf muscle)
RA - Right arm (on the inside, halfway between wrist and elbow)

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LA - Left arm (on the inside, halfway between wrist and elbow)
V1 - 4th intercostal space, at right sternal margin

V2 - 4th intercostal space, at left sternal margin
V3 - Midway between V2 and V4
V4 - 5th intercostal space at left midclavicular line
V5 - Same transverse level as V4, at anterior axillary line
V6 - Same transverse level as V4, at left midaxillary line
Position of chest and limb leads
NOTE: Subject and electrodes should not be exposed to conducting objects, even if
grounded.

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4. COLLECT SUBJECT ECG

 Ensure the laptop is connected to Wi-Fi/LAN. Login into ClinSpark study portal Gates-MRI-
TBD06-201 , select the appropriate study, and enroll the subject or search for already
enrolled subjects as per instructions provided in Enroll new subject for data collection.
 Then attach the AM12 lead cable to the subject and connect the other end of AM12 lead
cable to USB port of IQVIA CD provided study laptop.
 Before collecting the ECG, verify the subject demographic information on ‘Data Collection’
page matches the correct subject. If incorrect, click on ‘Change Subjects’ tab on top right-
hand side of the page and ClinSpark study portal will allow you to search and/or enroll new
subject.
 From the ‘Data Collection’ page, follow the instructions below for collecting and reviewing
a 10 second ECG.

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 Go to the appropriate Study Event form (as indicated in the table below) for the visit at
which you are recording the ECG
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

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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
 Click on Collect tab against the appropriate Study Event and you will be
directed to screen ECG form page.
 ECG form page will have ECG parameters fields blank and ‘Invoke device’ tab.
 Click on ‘Invoke device’ tab and you will get following message.
 Click ‘OK’
 RScribe Lite will be launched automatically via the ClinSpark Agent and it will begin to
capture ECG and Real time ECG waveforms will appear on screen.

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Real-time ECG view and associated options:
 Allows you to view the subject demographic fields. Click on the button and subject
information screen appears:

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Note: In case if any discrepancy is noted in subject demographic information, you should
notify IQVIA CD helpdesk and should not make any changes in ClinSpark study portal at
this time. ClinSpark will not apply demographic changes made in this function across all
features and will result in mismatch of subject demographic information’ within ClinSpark
study portal.
 Captures a section of ECG readings. Wherever you will place the rectangular
marker in the ECG stream in the lower section of the ECG streaming interface, it is
where it will pull ECG data. (The rectangular marker is shown in image below).
 This plot below is the result of capturing the ECG and two new buttons appears on the
screen

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 The button with the "10" plots the ten-best consecutive PQRST waves over the
whole span of data collection (at that point in time) and generates a graph like the one
above.
 The button appears (third from the top in above image), allows you to print the
generated plot in PDF format. If you want to print the ECG waveform, you should connect
the laptop to your printer and click on print icon. The printed ECG waveform can be filed in
the study file.
 The button allows users to print a ‘Full Disclosure Form’, i.e., the entire ECG tracing
with ECG waveform and study and subject demographic details from the real time ECG
screen.
 The final button allows you to exit ‘RScribe Lite’. This button ends ECG capture.
 If you want to perform additional ECG captures after the first ECG capture, in real time
ECG view screen, you should navigate to the bottom section of the interface (the ECG
data stream) which provides a wider view of all the ECG data collected so far. Then place
rectangular marker where you want to capture ECG data and then click on the blue button
that says "Select" to generate a plot like the one seen above.

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 Once the ECG capture is completed, the most recent ECG timestamp is saved and will
have ECG data auto-populated into the ECG form. (i.e. if more than one ECG was taken,
only the last one (timestamp wise) is useable and saved through ClinSpark).
 Collected ECG will contain following ECG parameters:
 PR Interval, QRS Interval, QT Interval, QTc Interval, QTcF Interval, QTcB Interval,
Rate (Ventricular - BPM), RR Interval, P-wave Axis orientation, QRS Axis orientation,
and T-Wave Axis orientation.
 Additionally, RScribe Lite also provides automatic interpretation of the ECG data in a
variable called EGTXT, it provides the date and time of the ECG capture in variable
EGDTC, and it provides a PDF document (EGPDF) of all captured ECGs, along with
subject information which you had entered at time of enrolling the subject.
 Click ‘Save and Close’ and you will be directed to ‘Data Collection’ Page.
 To view the collected ECG Waveform, on Data Collection screen select Form status as
‘Complete’.

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 Select Form (Visit) which you want to view. Click on Collect button. A "View" button will
appear next to the field EGPDF. Click on View and ECG waveform in PDF will open.

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 Generated PDF will contain subject’s demographic information, ECG recording

date/time, ECG machine generated interval measurements and interpretation.

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5. RECORDING REPEAT ECG

For repeat the subject visit, it can be done by ‘Add Repeat’ feature from ECG form
screen.
Please perform following steps to collect and save repeat visit:

 Search the already existing subject as per instructions provided in Search for
existing subject.
 Data Collection Screen will appear, click on the ‘Status’ dropdown, and select
‘Completed’.
 Select the visit for which repeat ECG needs to be collected and then click on
and ECG form screen will open
 From ECG form screen, click on Form Actions- Add Repeat on the top right corner of
your screen.

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 After clicking on Add Repeat, the following screen will appear.
 Click on ‘Add form’ and new ECG form will appear as per screenshot below and it
will allow you to collect repeat visit
 Click on Invoke Device tab and collect & save ECG as per instructions provided in
Collect subject ECG.
 After collecting & saving the ECG, repeat ECG will reflect on Data Collection page
with status as unscheduled form.

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Automated ECG file transfer to IQVIA CD
Once the subject’s ECG is collected and successfully saved in ClinSpark study portal, the real
time automated ECG file transfer will occur through the ClinSpark study portal to IQVIA CD ECG
analysis and storage system.
Please note, the ECG file transfer is automated when you are connected to internet.
If you are not connected to the internet during ECG collection, you can still collect the ECGs
however the automated ECG file transfer to IQVIA CD secure server occurs when the study
laptop is reconnected to internet. Please refer to Section Backup process (offline mode for ECG
collection/transfer) of this manual for detailed instructions for collecting and transferring the ECG
file when there is no internet connection.

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6. STUDY DATA AND ECG REVIEW
The list of ECGs collected and transferred, pending for collection (i.e. upcoming visits) and pdf
files of recorded ECG for a selected subject can be viewed at any given time from “Study Data”.
Study data
For a selected subject/s, the Study Data will generate a list of ECGs that have been collected,
machine generated interval measurements and ECG interpretation. It also allows you to view the
pdf files with ECG waveforms.
 Click on Study – Data. Study Data page opens
 Select Epoch and Cohort (for the study there is only one Epoch and Cohort that can be
optionally selected from the dropdown)
 Enter Subject ID/s
 Click on ‘Search’
 Complete List of ECGs collected for selected Subject ID/s will appear along with ECG
machine generated parameters values and Interpretations
 By clicking View EGPDF - you will be able to view and print the ECG PDF waveform

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Please note: The ECG measurements/ interpretations generated are not the final analysis
and you will receive an IQVIACD generated ECG report with Cardiologist confirmed
measurements and interpretations. Please refer to section ECG analysis, reporting and
data clarification process for IQVIACD ECG analysis and reporting process.

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7. OFFLINE MODE OF ECG COLLECTION (BACKUP)
There may be rare circumstances when you are not able to access your internet connection. In
such cases, you can still go ahead and collect the ‘RScribe Lite ECG’ and ‘Save’ in the ClinSpark
study portal.
NOTE: IQVIA CD does not recommend this process and every possible measure should
be taken to connect to the Wi-Fi/LAN and complete the ECG recording over the ClinSpark
portal (via internet).
Please perform following steps to collect and save RScribe ECG in offline mode.
 Click on ‘Show hidden items’ at laptop taskbar to run RScribe offline mode. RScribe offline
mode can only be launched when there is no internet connection. If internet connection is
available, you will get message asking you to access ClinSpark via web application.
 Click ClinSpark Agent icon and then Right Click & select ‘RScribe Offline’ only option.
 After clicking the on ‘RScribe offline mode’ tab following screen appears which will allow
you to enter following subject information:
 Study ID
 Subject ID: Enter the 8 -digit subject ID
 Study Event: As per visit codes under section Collect subject ECG
 DOB: 01/Jul/Actual Year Format
 Sex: Male/Female
 Notes : Add notes, if any (optional)

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 Please enter the subject information and click ‘Save’. You will get following message
and then click ‘OK’.
*Here ECG test refers to ECG recording.
NOTE: If you record more than one ECG in ‘RScribe Offline’ mode at a given time or
if you had earlier recorded an ECG in ‘RScribe Offline’ mode and did not associate
the ECG with a visit (event) form in the ClinSpark portal, you will receive the
following message

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 Always Click ‘No’ in order to collect a new ECG. This will allow you to later assign the
ECG to the correct visit.
 By Clicking ‘Yes’, any newly collected ECG will replace (i.e. overwrite) a previously
collected ECG.
 RScribe flow is then initiated, RScribe will launch and real time ECG waveform will appear.
 Follow same procedures as mentioned in Real time ECG view for Collecting ECGs in
ClinSpark study portal.
 Once you exit the RScribe, the collected ECG will be saved, and following screen will
appear.
 Click ‘OK’ and the collected ECG will be saved.

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 Collected ECG will be stored as an encrypted file which cannot be tampered by anyone
ensuring the ECG data is securely saved in system during offline mode.
 Once internet connection is restored, login to ClinSpark study portal and go to ‘Data
Collection’ page.
 Enroll the Subject/Select already enrolled Subject as per instructions provided in

Section Enroll new subject for data collection of the manual.
 Click ‘Collect’ tab against the visit form for which you want to assign the ECG recorded in
offline mode. You will be directed to ECG form which has ‘Invoke device’ tab.
 Click on ‘Invoke device’ tab and you will get message stating ECG collected while in offline
mode are available. Click ‘YES’.
 System will synchronize and will allow you to acquire the ECGs which were acquired
during ‘RScribe offline’ mode.
 Select the subject ECG that needs to be acquired.
 Click on ‘Acquire’ and following message will appear.

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 Click ‘Yes’. After clicking ‘YES’, the ECG recorded in offline mode is assigned to the
selected event (visit) form.
NOTE: Once you select ‘Yes’ the action cannot be undone. Hence, please be sure to
assign the appropriate ECG recorded in offline mode to the correct form.
 The ClinSpark study portal will cross-verify the subject demographic information entered in
enrolled subject with subject demographic entered in offline mode. If any mismatch in
subject demographic is identified, then following message will appear.
 When ‘No’ is selected the ECG Acquire screen can be closed and System will display
message "Device data not acquired. Retry?"
 Click ‘OK’ and System will display message "Order not found when attempting result
search”. Click “OK”. The screen will close, and user will be brought back to the data
collection screen.
 When ‘Yes’ is selected ECG form with all ECG parameters and ECG interpretation will be
filled and be viewable. In this scenario, the ECG file transmitted to IQVIA CD will reflect the
information entered during the offline mode recording, however the IQVIA CD will consider
the enrolled ECG information in the online subject enrollment section, for further
processes.
 Complete the workflow by selecting Save and Close.

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REPEAT VISIT (Offline mode)
In rare case, if you want to repeat the subject visit for already collected and saved, please follow
the same procedures as mentioned in Section Recording Repeat ECG.
Repeat ECG will appear on Data Collection page with status as unscheduled form. Please see the
screenshot below.
Note: Ensure that accurate subject demographics are entered in offline mode. Also, take
extra precautions while selecting the subject and ECG visit so that correct ECG is
uploaded under accurate subject.

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8. RECEIVING ECG REPORT FROM IQVIA CD

When an ECG is transmitted to IQVIA CD, it automatically gets labeled as “UNCONFIRMED”.
The IQVIA CD ECG Receipt Technician will review the transmitted ECG for completeness of the
demographic information provided by site. If the demographic information is correct and
complete, the ECG is forwarded for analysis.
NOTE: Procedure for technically unacceptable ECG: If the technical quality of the
transmitted ECG is found to be unacceptable, the ECG will still be analyzed and reported
back to the site. Depending on the extent of analysis that is possible, the report will carry
the ‘Overall ECG Interpretation’ as ‘Incomplete Analysis’ or ‘Uninterpretable’.
ECG Review and Analysis

 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) as agreed with the sponsor
 Each report will be flagged, as explained in Section ECG reporting: Flagging an ECG.
 Please note that the ECG reports may take added 24 hours to be reported if the ECG is
received/analyzed on any of IQVIA CD holidays.
 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.

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 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.
ECG reporting
 Every ECG report includes the study and site information, subject demographics, ECG
recording date and time, measurements and comprehensive interpretation. The report DOES
NOT contain the ECG waveform itself.
 Each ECG report has a section of ‘Overall ECG Interpretation’ which serves to distinguish
between Normal ECGs, ECG anomalies where no further investigation is required, and ECG
anomalies where trial exclusion, further cardiovascular investigation and/or prompt action may
be necessary depending on the clinical context. If any ECG is technically unacceptable or
invalid, a suitable flag to that effect is put in the section of ‘Overall ECG Interpretation’. Please
refer to Appendix B: Sample ECG report for a sample ECG report.

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 Accordingly, either one of the following ‘flags’ will appear in the ‘Overall ECG Interpretation’
section of the ECG report:
 Normal
 Abnormal Insignificant
 Abnormal Significant
 Incomplete analysis
 Un-interpretable
 The ECG report also includes a listing of significant values/interpretations that are deemed to
be important findings (when applicable) based on Cardiologist's over read and the ‘ECG
abnormality Criteria’ for the study.
 All ECGs shall be analyzed based on the ‘ECG Abnormality Criteria’ defined in agreement
with Sponsor and considering the study protocol.
NOTE: The decision to include/exclude a subject with an ECG flagged as Abnormal lies
with the Investigator and ultimately sponsor. IQVIA CD interpretation should not
include/exclude subjects and should be regarded as an expert Cardiologist’s suggestion.
The service is designed to ASSIST the Investigator’s decision making but NOT to
REPLACE it.
Data Clarification (Query) Process

 When ECGs are received at IQVIA CD with missing or discrepant data, a ‘Data Clarification
Form’ (DCF) form is raised to the site.
 The study and subject demographic data are essential for the medical review and identification
of an ECG and therefore, the ECG analysis and reporting is kept pending until the DCF is
resolved by fax, phone or via Infosario portal. The pending ECGs are analyzed and reported
back within the agreed turnaround time after the receipt of the resolved DCF. A sample DCF
form is available in Appendix C: Sample DCF template.
 For any missing/incorrect/incomplete information on the first ECG received for a subject, a
DCF will be raised to the site.
 For missing/incorrect/incomplete information on subsequent ECGs, IQVIA CD will refer

information from first ECG.

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 Total three reminders will be sent to the site at a frequency of 3 days.
All open DCFs post the above reminders and all applicable follow-up procedure will be shared with
IQVIA Clinical team.
 Site staff can also call the IQVIA CD helpdesk to provide the resolution. The site staff must
resolve the DCF by phone or by entering the resolution on the Cardiac Safety web portal or by
providing signed and dated copy of the resolution via fax/email within 24 hours of the DCF
being raised. The DCF should be signed and dated if resolved by fax/email.
 A delay in the query resolution process will result in a delay in reporting the ECG to the site.
Cardiac Safety web portal through IQVIA Infosario
 Site can login to IQVIA CD Cardiac Safety Web portal for generating listing of ECGs, analyzed
ECG reports or provide resolution to Data Clarification query. Please refer Appendix D for
detailed steps.

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9 ORDERING SUPPLIES AND RETURNING ECG EQUIPMENT
Ordering supplies
IQVIA CD can be contacted 24x7 by phone or email to order supplies. All supplies requests are
processed immediately. Please allow 5-7 working days (depending on the location of the site) for
the supplies to reach your site after placing the request.
Ordering by phone: Call our IQVIA CD helpdesk at the number provided under the ‘Project
Contact Information’ section of this manual.
Ordering by email: Write an email to CSSCDSupport@quintiles.com
DO NOT forget to provide your protocol ID, site number and exact quantity and type of
supplies while placing the order. IQVIA CD will not be able to ship the supplies in absence
of this information.
Returning the ECG Equipment and Accessories

 Please attempt to save all the shipping/packing materials that accompanied the laptop and
ECG kit when it arrived. You can reuse it to return the equipment and its accessories at the
end of the study. If you were unable to maintain these materials, please contact the IQVIA CD
helpdesk to request packaging materials when you receive the recall notification.
 Once the study/protocol is completed and you do not need the equipment, please contact
CSSCDSupport@quintiles.com to receive detailed instructions for returning the equipment.
 Help us prevent unnecessary costs to the sponsor by returning the equipment as soon as
possible.
 Your site is not required to return unused electrodes. If you have any questions, please
contact the IQVIA CD helpdesk.

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10 PROJECT CONTACT INFORMATION
IQVIA CD helpdesk (24 x 7 Multilingual) phone:

1. Ordering Supplies
2. Requesting additional copies of ECG reports
3. Requesting IQVIA CD to raise a Data Clarification Form (DCF)
4. Any other ECG related queries/supports
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:
1. Ordering supplies, CSSCDSupport@quintiles.com
2. Any other ECG related queries
Fax:
1. Sending resolved ‘Data Clarification Forms’ Easy link fax numbers given in the
(Queries) table below
1st Dialing Option 2nd Dialing Option 3rd Dialing Option

Country
[UIFN] [ITFS As Back Up]
1010-5511-00/105-
11
Add AT & T
Philippine Common Number
s +800-72720030 1-800-1-114-2245 866-373-4072
0-800-99-0123
Add AT & T
South Common Number
Africa +800-72720030 080-09-82652 866-373-4072
3rd Dialing Option

1st Dialing Option 2nd Dialing Option
Country [US Toll As Back
[ITFS] [AT&T]
Up]

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ECG Solution
0-800-50-288/0-800-70- +1-919-323-3710
088
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
1st Dialing Option [US

Country
Toll]
Kenya +1-919-323-3710
Uganda +1-919-323-3710

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11 TROUBLESHOOTING
Wandering baseline: wavy or unstable baseline
A wandering or unstable baseline is a result of movement of the subject or the subject cable
during ECG acquisition or a result of poor skin-electrode contact. To avoid a wandering baseline,
the subject must relax during the acquisition and the cable must remain still and there should be
a very good skin-electrode contact.
Muscle tremor
This is usually caused if the subject is moving or if the muscles are tense. Please ensure subject
is relaxed before and during ECG acquisition
Lead disconnected or flat line
Flat lines may be because of a bad lead wire connection or an improper skin-electrode contact.
Make sure all lead wires are well connected and a good skin-electrode contact established.
Always check the lead fail indicator before acquiring the ECG.

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ClinSpark Study Portal related troubleshooting

 Unable to login into the ClinSpark Study Portal due to incorrect password entry:
The ClinSpark study portal allows you to set up password after you have failed to login at
least one time. Please refer to Appendix A: Reset Password of this manual for detailed
instructions on ‘Self-Service Password Reset’ in the ClinSpark study portal.
 Invoke Device Tab does not appear after clicking on Collect tab to collect ECG:
If you encounter this problem, please contact IQVIA CD helpdesk as there may be some
issue related to installation of ‘RScribe Lite’ and/or ‘ClinSpark Agent’ software on the IQVIA
CD provided study laptop.
 Unable to access the ClinSpark study portal URL link:

If you encounter this problem, please check your internet connection. If there is issue related
to your local internet connection, please refer to section Backup process (offline mode for
ECG collection/transfer) of this manual for Offline mode ECG collection/transfer.
 Unable to open/view the ECG waveforms in the ClinSpark Study Portal:

If you are unable to view or open the EGPDF waveforms, please check if you have used
Google Chrome to access the ClinSpark study portal. Full functionality of the ClinSpark
study portal can be visible only in Google Chrome™ and not on any other web browsers.
Please contact IQVIA CD helpdesk if further assistance is required.

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12 APPENDICES
 Appendix A: Reset Password in IQVIA ClinSpark system
 Appendix B: Sample ECG Report
 Appendix C: Sample DCF Report
 Appendix D: Cardiac Safety Web Portal
 Appendix E: List of Abbreviations Commonly Used in ECG Reports

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Appendix A: Reset Password in IQVIA ClinSpark system
 Access ClinSpark study portal at https://iqvia.ClinSpark.com/login, using the login

credential shared by IQVIA CD.
 Change your password during the first login.
Note: ClinSpark has been optimized for Google Chrome.
 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.

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 User will receive email from ClinSpark

Alerts <no-reply@clinspark.com> on
registered email id. If you haven’t
received the email check your SPAM
folder.
 The reset link will be active until the

time specified in the password reset
email.
 Click on “Reset your password” link in the

email. Reset password window will
open.
Update your password and login to
ClinSpark portal.

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Appendix B: Sample ECG report

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Appendix C: Sample DCF template

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Appendix D: Web portal

 IQVIA CD portal can be accessed from the link: https://infosario.quintiles.com.
 The user would be notified by an email from IQVIA CD consisting of the username and
detailed login instructions.

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ECG Solution
 For issues related to login or password reset, please refer to the ‘Need Help” link on the
login page:
 To contact the IQVIA IT helpdesk for any questions/issues related to the web portal, please
refer to the link named “Click here”:

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 From the page you can use the email and phone links to reach out to IQVIA IT team.
 Once you login, Go to Cardiac Safety Tab.

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 To help you navigate through the various topics, you can click on the Help section.

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For DCF resolution on the web portal:
 Click on More Search option

 Select Protocol ID, Site ID and click Search
 Click on Pending DCF column to enlist all outstanding DCFs for the site
 DCF can be viewed by clicking the icon
 A Site User can enter the resolution in “Please Enter Your Response here:” section
 Click on Send to submit your response
 An email confirmation appears on screen stating DCF resolution sent to IQVIA CD team
 Click OK to close the DCF
 Follow steps as above to resolve all pending DCFs

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Appendix E: List of Abbreviations Commonly Used in ECG

Reports
ABBREVIATION MEANING
RHYTHM
NSR Normal Sinus Rhythm
S.Brady Sinus Bradycardia
S.Tachy Sinus Tachycardia
A.F / A.Fib Atrial Fibrillation
A.Flut. Atrial Flutter
SVT Supraventricular Tachycardia
PSVT Paroxysmal Supraventricular Tachycardia
PAT Paroxysmal Atrial Tachycardia
VT Ventricular Tachycardia
VF Ventricular Fibrillation
SVE/APB/ AES Supraventricular Ectopic beat/ Atrial Premature Beat
PAC / APC Premature Atrial Contraction
VE/VPB/ VES Ventricular Ectopic Beat/ Ventricular Premature Beat
PVC / VPC Premature Ventricular Contraction
AXIS
LAD Left Axis Deviation
RAD Right Axis Deviation
CONDUCTION
IVCD Intraventricular Conduction Delay
LAHB Left Anterior Hemiblock
LPHB Left Posterior Hemiblock
RBBB Right Bundle Branch Block
IRBBB / ICRBBB Incomplete Right Bundle Branch Block
LBBB Left Bundle Branch Block
ILBBB / ICLBBB Incomplete Left Bundle Branch Block
1st. Deg. AVB 1st Degree Atrioventricular Block
CHB Complete Heart Block
MORPHOLOGY
LVH Left Ventricular Hypertrophy*
RVH Right Ventricular Hypertrophy
LAE Left Atrial Enlargement
RAE Right Atrial Enlargement
* Voltage Criteria (i.e., the Sokolove Criteria) for LVH: S in V1 or V2 + R in V5 or V6 ≥ 35 mm

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PRE-EXCITATION SYNDROMES
WPW Wolf Parkinson White syndrome
LGL Lown Ganong Levine syndrome
MISCELLANEOUS
M/p - Most probably
PMH - Past Medical History
+ve FHx Positive family history
CHOL^ - Hypercholesterolaemia
HTN - Hypertension
HR - Heart rate


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IQVIA Connected Devices Investigators Manual for ClinSpark RScribe

Investigator ClinSpark RScribe Manual for the

Document Version History:

Version # Effective Date Significant Changes

Version 01 16th May 2023 Initial Version

Protocol id Gates-MRI-TBD06-201, Investigators Manual Version 01_ 16th May 2023

Template No.: CS_TP_CND0143 Revision 1 Reference: CS_OP_CND0010

Effective Date: 16Jul2021

BEFORE YOUR FIRST SUBJECT....................................................................................................................................................6

2. CLINSPARK STUDY PORTAL................................................................................................7

STUDY DASHBOARD, STUDY DATA AND REPORT............................................................................................................................8

5. RECORDING REPEAT ECG..................................................................................................24

6. STUDY DATA AND ECG REVIEW........................................................................................28

REPEAT VISIT (OFFLINE MODE)............................................................................................................................................35

ECG Review and Analysis...............................................................................................................................................36

10. PROJECT CONTACT INFORMATION..............................................................................41

Wandering baseline: wavy or unstable baseline...........................................................................................................43

APPENDIX A: RESET PASSWORD IN IQVIA CLINSPARK SYSTEM.....................................................................................................46

Protocol id Gates-MRI-TBD06-201, Investigators Manual Version 01_ 16th May 2023

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APPENDIX C: SAMPLE DCF TEMPLATE......................................................................................................................................50

Protocol id Gates-MRI-TBD06-201, Investigators Manual Version 01_ 16th May 2023

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Protocol id Gates-MRI-TBD06-201, Investigators Manual Version 01_ 16th May 2023

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Additional electrodes can be ordered if needed during the study conduct by

Before your first subject

 Review training materials

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 Collect a test ECG

it to IQVIA CD by accessing ClinSpark study portal ie Gates-MRI-TBD06-201_Proficiency

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2. CLINSPARK STUDY PORTAL

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Study dashboard, study data and report

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Enroll new subject for data collection

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 Verify subject demographics and then click ‘Save’

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Search for existing subject

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