Difference between revisions of "Clinical Integrated Study Data and Analysis Data Reviewer's Guide"

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| Hanne Ellehoj || Participant || Lundbeck || hanq@lundbeck.com
| Hanne Ellehoj || Participant || Lundbeck || hanq@lundbeck.com
| Yu (Ella) Cheng || Participant || JNJ || ycheng58@its.jnj.com

Revision as of 02:33, 13 August 2019

Project Overview

The cSDRG and ADRG apply to a single study. Sponsors have used these templates when creating a reviewer’s guide for integrated SDTM and a reviewer’s guide for integrated ADaM 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 SDTM and integrated ADaM. 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

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
Madhusudhan Papasani Participant Merck madhusudhan.papasani@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 chandrakalas@yahoo.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
Yu (Ella) Cheng Participant JNJ ycheng58@its.jnj.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 July 2019
Draft Reviewer's Guide(s) Template November 2019
Public Review January 2020
Publish Deliverables February 2020

Project Activities

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