Clinical Integrated Study Data and Analysis Data Reviewer's Guide

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Project Overview

The cSDRG and ADRG apply to a single study. Sponsors have used these templates when creating a reviewer’s guide for integrated Study Data and a reviewer’s guide for integrated Analysis Data. The template has to be changed in order to document the information for multiple studies. There is an opportunity to create a template for integrated Study Data and integrated Analyses Data. The project team will determine if this can be accomplished in one reviewer’s guide or if there should be two separate reviewer’s guides. Deliverables include a template, completion guidelines, and example documents.

Project Leads

Kiran Kundarapu Project Lead Merck
Satheesh Avvaru Project Lead MaxisIT/PPD
Wendy Dobson PHUSE Project Manager PHUSE

Project Members

Susheel Arkala Participant MMS Holdings
Jian Huang Participant Celgene
Janet Low Participant Merck
Vanitha Dareedy Participant Gilead
Vishnu Kollisetti Participant PPD
Sameer Saxena Participant Bayer
Imran Syed Participant Bayer
Kapila Patel Participant Syneoshealth
Mithun Ranga Participant Independent
Lokesh Usher Participant Independent
Kala Chandra Participant VitaDataScience
Sapan Patel Participant Merck
Raghava Regulla Participant Bayer
Yaling Teng Participant Amgen
Tanvi Gupta Participant PPD
Krishna Varkur Participant PPD
Srinivas Kovvuri Participant Covance
Shyamprasad Samisetti Participant Merck
Randi McFarland Participant IconPLC
Carey Smoak Participant S-Cubed
Hanne Ellehoj Participant Lundbeck
Pranab Mitra Participant Merck
Sunil Gupta Participant Industry
Anita Baniya Participant PPDI
Shitanshi Mehta Participant Industry
Swathi Kotla Participant Industry
Sandy VanPelt Participant Industry
Aurora Liao Participant Industry
Adie Bonwick Participant GSK
Aron Anton Participant PPDI
Anand Jayaraman Participant Merck
Rajeswari Veeramallu Participant PPDI
Abhilash Vasu Chimbirithy Participant Merck
Sarad Nepal Participant Merck
Charanjit Kahlon Participant Softworld Inc
Sharayu Nadkarni Participant Pfizer
Laura Schafer Participant Bayer
Ghanshyam Jangid Participant Merck
Micky Salgao-Gomez Participant Pharmastat
Ellen Asam Participant Merck
Michael Marroquin Participant Pharmastat
James Gaiser Participant Prometrika <>

Project Updates

Provide project updates in this section.
Date: Description of Update

Objectives and Timelines

List proposed project deliverables and timelines.

Kick Off Meeting September 2019
Draft Reviewer's Guide(s) Template March 2020
Draft Completion Guidelines April 2020
Draft Examples April 2020
Public Review May 2020
Publish Deliverables June 2020

Project Activities

This section can document project activities or serve as a jumping off point to other pages in the project.