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Project

Scope

Scope 

The cSDRG and ADRG apply to a

single study

single study. Sponsors have used these templates when creating a reviewer's guide for integrated Study Data and 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 guide. Deliverables include a template, completion guidelines and example documents.



Project LeadsEmail

Kiran Kundarapu, Loxo Oncology

kiran

kkundarapu@loxooncology.

kundarapu@merck.

com

Satheesh Avvaru

avvarusatheesh@gmail

, Alexion AstraZeneca Rare Disease

satheesh.avvaru@alexion.com

Randi McFarland, Ephicacy

randi.mcfarland@ephicacy.com
Wendy Dobson (

Nicola Newton, PHUSE Project

Manager)

Assistant

wendy@phuse

nicky@phuse.global


Status
colourBlue
titleCurrent Status

 Q12021
  • iADRG template completed​.
  • icSDRG template in progress​.
  • Identified team members to work on example documents and completion guidelines​.
  • iADRG example document draft in progress​.
    • FDA is on board to support the project. Lisa and Nhi from FDA joined team meeting to provide input.                                      

    Q2 2024

    • Finished incorporating PHUSE CSS 2023 comments (121) into icSRDG draft template; 12 questions to present at the 2024 CSS.

    • Draft icSDRG example document on hold until template is stable. 







    Objectives & DeliverablesTimelines
    Draft Reviewers Guide(s) TemplateDec 20Draft ExamplesApr 21Draft Completion GuidelinesMay 21Public ReviewJune 21Publish final deliverableAug 21FDA ReviewPending FR NoticeProject MembersOrganisationAbhilash Vasu ChimbirithyMerckAdie BonwickGSKAnand JayaramanMerckAnita Baniya PPDIAron AntonPPDIAthenkosi NkonyeniIndustryAurora LiaoIndustryBidhya BasnetGenentechCarey SmoakS-cubedCharanjit KahlonSoftworld Christine RossinPfizerEllen AsamMerckGhanshyam JangidMerckHanne EllehojLundbeckImran SyedBayerJames GaiserPrometrikaJanet LowMerckJane LozanoEli LillyJian HuangCelgeneKala ChandraVitaDataScienceKapila PatelSyneos HealthKrishna VarkurPPDLaura SchaferBayerProject MembersOrganisationLokesh UsherIndustryMichael MarroquinPharmastatMicky Salgao-GomezPharmastatMithun RangaIndustryPranab MitraMerckRaghava RegullaBayerRajeswari VeeramalluPPDIRandi McFarlandICONSameer SaxenaBayerSandy VanPeltPfizerSapan PatelMerckSarad NepalMerckShitanshi MehtaIndustryShyamprasad Samisetti MerckSrinivas KovvuriCovanceSunil GuptaIndustrySusheel ArkalaMMS Swathi KotlaIndustryTanvi Gupta PPDVanitha DareedyGileadVishnu KollisettiPPDI

    iADRG template, completion guidelines and 2 examples

    		Q2 2023

    icSDRGproject: integrated clinical Study Data Reviewer’s Guide (icSDRG) Template, Completion Guidelines and Example 

    		Q2 2024
    Yaling TengAmgen