Session 18 - A Deep Dive into Master Protocol Trial and Data Management – Experts Opinion

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Tuesday, September 15, 2020: 11:15 AM - 12:15 PM
/ CEU Credits:0.2


Abhishek Banerjee
Trial Data Manager
Tata Consultancy Services, contracted to work for Boehringer Ingelheim Pharma GmbH & Co. KG
Mithilesh Sharma
SAS Programmer
eClinical Solutions
Sonal Shrivastava
Associate Manager
Parexel International
Session Chair
Yashpalsinh Raj
Associate Data Management Lead
Parexel International


High Quality Data/Evidence is essential to make healthcare decisions. Each clinical trial is conducted to answer specific question(s) for a group of people/subpopulation. As per traditional approach to bring a medical product to the market, a series of sequential clinical trials are conducted to generate sufficient evidences. However, the major challenge is to answer multiple questions more efficiently in less time. So, it is necessary to conduct clinical trials using innovative designs.

Now a Days, many trials are conducted using Master Protocol Trial design where multiple sub studies are being part of a single protocol, without a need to develop a new protocol for every trial. There are three terms which are used for specific type of Master Protocol Trial: 1) Basket Trial Design 2) Umbrella Trial Design and 3) Platform Trial Design​

These designs are very complex in comparison of traditional clinical trials. These trials contain multiple sub studies which makes it challenging/difficult: 

  • To design the eCRF for sub studies and programming the edit checks.
  • There may be changes during the conduct phase as well where new trial arm may be added, existing arm/sub study may be modified.
  • To review and clean the data as there may be overlap of the patients in different sub studies.
  • To perform Interim Analysis because multiple drugs are being tested or multiple disease/sub-populations are involved during the trial.
  • Preparing Study Data Tabulation Model (SDTM) and Analysis Dataset Model (ADaM) for the sub studies.

This session will focus on: 

  • Understand Master Protocol Trial using different study designs (Umbrella, Basket and Platform).
  • Challenges Clinical Data Management can face during Setup, Conduct and Close Out phase. 
  • Implement Data Submission (SDTM) and Analysis (ADaM) model.   
  •  Best practices/approaches to Plan and execute Master Protocol Trial.



1. Master Protocol Design and Importance
2. Database Setup and Challenges
3. Reviewing Data, Post Production Changes and Challenges
4. Implement Data Submission (SDTM) and Analysis (ADaM) model


CDM Certification Competencies::
CRF Design,Data Base Updates,Clinical Database Design/Relational Data Bases

Target Audience:
Statistician,Data Managers,Database and SAS Programmers