Difference between revisions of "Clinical Integrated Study Data and Analysis Data Reviewer's Guide"
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| Yu (Ella) Cheng || Participant || JNJ || ycheng58@its.jnj.com | | Yu (Ella) Cheng || Participant || JNJ || ycheng58@its.jnj.com | ||
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| + | | Pranab Mitra || Participant || Merck || pranab.mitra@merck.com | ||
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Revision as of 09:39, 15 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 |
| Pranab Mitra | Participant | Merck | pranab.mitra@merck.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.
