Clinical Data Review

Suggested pathways for performing Ongoing Data Review and Medical Review in SmartTrials

April 2020

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 Traditional Clinical Data
Review Process

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 Challenges continuing with a Traditional Data Review Process

Custom created listings and line listings on a per study basis need
significant programming efforts and consume time

Data is not current. Review is often conduced on stale copies of

data and listings (using offline generated reports and listings)

Lack of visualization tools/options to better detect risks or hidden

trends

Dependency on listings to get generated that consumes time

and sometimes might delay

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 Improving Data Quality and Safety
with a Continuous Data Review
Process

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Suggested Process at full adoption of SmartTrials Data Review
Data review pathways Review by AEs / Other Views (Vaccine,
Review by Lab Analytes Samples, Medication. EOS Review each Subject
available in SmartTrials Solicited Events etc)

Role Method used To Review To perform an action

• Data outliers, anomalies, and drill

• Use information to review/generate patient
down to sub-populations or
specific patient(s) profiles
• Detect risks or safety signals
Data Review/ Medical Review
contributors

• Individual patient review and re- • Mark patients as reviewed

review incremental data changes • Track patient review status to closure

Medical review contributor-SMM

• Data outliers, anomalies, by site or

Review by site country
or country • Detect risks or safety signals by site or
country

• Individual patient profiles specific to a site

Monitoring Team or country
• Review and Re-review incremental data
changes

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 Sanofi Pasteur Current Data Review
process v/s Data Review process
using Cognizant SmartTrials

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Sanofi Pasteur Data Review process – Login Page
Current way of working Using SmartTrials – Way of working

1.Login into Webportal: Login to Cognizant SmartTrials:

http://cdmportal.pasteur.aventis.com/ https://sanofival.smarttrials.cognizant.com/SSO
Enter User Name & password
Note: Accessible only through MODERN environment Note: Accessible through Internet URL to the end users

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Sanofi Pasteur Data Review process – Study Selection

Current way of working Using SmartTrials – Way of working

2. Select Project name  Study Name  Applicable folder for DRM Click on Clinical Data Review Module  Select Study  Click on ‘View
Dashboard’

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Sanofi Pasteur Data Review process – Reports Selection
Current way of working Using SmartTrials – Way of working

3. Select Project name  Study Name  Applicable folder for DRM Select the ‘Type of Review’  Click on the reports to review

Path: / DRM#07_13MAR2020 / DP_28JAN2020 / Data Review /

Concomitant medications

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Sanofi Pasteur Data Review process – Open and View Report
Current way of working Using SmartTrials – Way of working

4. Select the report for review Click the report you want to review

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Sanofi Pasteur Data Review process – Date Prompt Functionality on same screen
Current way of working Using SmartTrials – Way of working

5. All Data and Date Prompt Reports All Data and Modified/ New Data between 2 dates can be viewed on the same screen

Currently we are switching between 2 different

Folders/Listings to review All Data and Updated/New
data.

The slider can be used to view All Data or you can choose the date from which you want to
review i.e. Updated or New data without moving into different screen or report or Listing.

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Sanofi Pasteur Data Review process – Different Graphical Views in SmartTrials
Using SmartTrials – Way of working

Different Graphical Views (i.e. Bar Chart, Pie Chart, Line Chart) for different domains are available which provides better view for Analysis.

• The graphical views also allows you to select/filter data that you are interested to view.
• On selection it drills down to the details of subjects corresponding to respective selection.

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Sanofi Pasteur Data Review process – Patient Profile Graphical Visualization
Using SmartTrials – Way of working

Forms: Informed Consent, Visit, Blood Sampling, Vaccination, Adverse Events, Solicited Events, Prohibited Medication, Contraindication, Pregnancy,
End of Study and Safety Follow Up.
Color By: It will help to identify the type of data.

•
• Shape By: It will help to identify the different forms.
•

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Sanofi Pasteur Data Review process – How do you interact with Data?
2 3

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Sanofi Pasteur Data Review Process – Where will you enter the review comments?
Current way of working & For the SmartTrials Evaluation

Enter the review comments in CMTL in CeDoc Pasteur

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Benefits : Switching to Continuous Data Review

Traditional Process Continuous Data Review

Custom created listings and line listings on a Common data review package that works for
per study basis need significant programming all studies (immune to metadata changes
efforts and consume time between studies)

Data is not current. Review is often conduced Data is refreshing continuously and review is
on stale copies of data and listings (using conducted on most current version of the
offline generated reports and listings) data. Ability to view incremental data
changes. Immune to mid-study changes.

Lack of visualization tools/options to better Rich data visualization views to help detect
detect risks or hidden trends data outliers, anomalies or a potential safety
signal

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Thank You