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Scope

Project

Scope 

The cSDRG and ADRG apply to a single studysingle 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

kiran.kundarapu@merck

, Loxo Oncology

kkundarapu@loxooncology.com

Satheesh Avvaru, Alexion AstraZeneca Rare Disease

satheesh
.avvaru@ppd
.avvaru@alexion.com

Randi McFarland, Ephicacy

randi.mcfarland@ephicacy.com
Katie Warren (

Nicola Newton, PHUSE Project Assistant

)

katie@phuse

nicky@phuse.global

Objectives & DeliverablesTimelinesFinalisation of full BDRG package (assessing/incorporating comments from public review)Apr-2022Full team including FDA limited review (CDER & CBER PHUSE BIMO team members)Apr-2022Finalisation of full BDRG package (incorporating any remaining comments from the full PHUSE BIMO team)Apr-2022Rollout: PHUSE US ConnectMay-2022


Status
colourBlue
titleCurrent Status

Q22022
  • Finalisation of full BDRG Package. 
  • Leads working on PHUSE US Connect presentation.
  • Final publication end of April 2022 to present at PHUSE US Connect.
Project 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 ChandraVita Data ScienceKapila PatelIQVIA Krishna VarkurPPDLaura SchaferBayer

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

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
Project MembersOrganisationKapil Arnand ParexelLokesh UsherIndustryMathura RamanathanLabcorpMichael MarroquinPharmaStatMicky Salgao-GomezPharmaStatMithun RangaIndustryPranab MitraMerckRaghava RegullaBayerRajeswari VeeramalluPPDIRandi McFarlandICONSameer SaxenaBayerSandy VanPelt NguyenPfizerSapan PatelMerckSarad NepalMerckShitanshi MehtaIndustryShyamprasad Samisetti MerckSrinivas KovvuriLabcorpSunil GuptaIndustrySusheel ArkalaMMS Swathi KotlaIndustryTanvi Gupta PPDVanitha DareedyGileadVishnu KollisettiPPDIYaling TengAmgenYoshiko KitagawaONO PharmaWinkle Lu Industry