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 kiran.kundarapu@merck.com
Satheesh Avvaru Project Lead MaxisIT/PPD satheesh.avvaru@ppdi.com
Wendy Dobson PHUSE Project Manager PHUSE wendy@phuse.eu

Project Members

Susheel Arkala Participant MMS Holdings sarkala@mmsholdings.com
Jian Huang Participant Celgene Jihuang@celgene.com
Janet Low Participant Merck Janet_low@merck.com
Vanitha Dareedy Participant Gilead vanitha.dareddy@gilead.com
Vishnu Kollisetti Participant PPD Vishnu.Kollisetti@ppdi.com
Sameer Saxena Participant Bayer Sameer.Saxena@bayer.com
Imran Syed Participant Bayer Imran.syed@bayer.com
Kapila Patel Participant Syneoshealth Kapila.Patel@syneoshealth.com
Mithun Ranga Participant Independent Mithunranga@gmail.com
Lokesh Usher Participant Independent usherlokesh@gmail.com
Kala Chandra Participant VitaDataScience kala@softworldinc.com
Sapan Patel Participant Merck sapan.patel@merck.com
Raghava Regulla Participant Bayer raghava.regulla@bayer.com
Yaling Teng Participant Amgen yteng@amgen.com
Tanvi Gupta Participant PPD Tanvi.Gupta@ppdi.com
Krishna Varkur Participant PPD Krishna.Varkur@PPDI.com
Srinivas Kovvuri Participant Covance Srinivas.Kovvuri@covance.com
Shyamprasad Samisetti Participant Merck shyamprasad.samisetti@merck.com
Randi McFarland Participant IconPLC Randi.McFarland@iconplc.com
Carey Smoak Participant S-Cubed cas@s-cubed.dk
Hanne Ellehoj Participant Lundbeck hanq@lundbeck.com
Pranab Mitra Participant Merck pranab.mitra@merck.com
Sunil Gupta Participant Industry guptaprogramming@gmail.com
Anita Baniya Participant PPDI Anita.Baniya@ppdi.com
Shitanshi Mehta Participant Industry Shitanshi.Mehta91@gmail.com
Swathi Kotla Participant Industry Swathi.Kotla@merck.com
Sandy VanPelt Participant Industry Sandra.VanPeltNguyen@pfizer.com
Aurora Liao Participant Industry Aurora.Liao@cytel.com
Adie Bonwick Participant GSK adrienne.m.bonwick@gsk.com
Aron Anton Participant PPDI Aron.Anton@ppdi.com
Anand Jayaraman Participant Merck anand.jayaraman1@merck.com
Rajeswari Veeramallu Participant PPDI Rajeswari.Veeramallu@ppdi.com
Abhilash Vasu Chimbirithy Participant Merck chimbirithy_abhilash@merck.com
Sarad Nepal Participant Merck Sarad.Nepal@merck.com
Charanjit Kahlon Participant Softworld Inc ckahlon@softworldinc.com
Sharayu Nadkarni Participant Pfizer sharayu.nadkarni@pfizer.com
Laura Schafer Participant Bayer laura.schafer@bayer.com
Ghanshyam Jangid Participant Merck ghanshyam.jangid@merck.com
Micky Salgao-Gomez Participant Pharmastat mgomez@pharmastat.com
Ellen Asam Participant Merck ellen_asam@merck.com
Michael Marroquin Participant Pharmastat mmarroquin@pharmastat.com
James Gaiser Participant Prometrika <jgaiser@prometrika.com>

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.