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Project Scope 

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 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

)

kundarapu@loxooncology (

, Alexion

)

AstraZeneca Rare Disease

satheesh.avvaru@alexion.com
Katie Warren (

Randi McFarland, Ephicacy

randi.mcfarland@ephicacy.com

Nicola Newton, PHUSE Project Assistant

)

katie@phuse.globalObjectives & DeliverablesTimelines

iADRG template, completion guidelines and 2 examples

Q3 2022

icSDRG template, completion guidelines and an example

Q4 2022


Status
colourBlue
titleCurrent Status

Q3/4  2022Hoping to publish theiADRG by the end of Q4 2022 
  • Continue working on the icSDRG in Q1 2023  
  • Project MembersOrganisationAbhilash Vasu ChimbirithyMerckAdie BonwickGSKAdity Shelke SASAnand 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 MarroquinPharmaStatMichael Wise Apellis Micky Salgao-GomezPharmaStatMithun RangaIndustryMrudula MogallaAvance Clinical Pranab MitraTakedaPriyanka Pollarine BiogenRaghava RegullaBayerRajeswari VeeramalluPPDIRandi McFarlandEphicacySameer SaxenaBayerSandy VanPelt NguyenPfizerSapan PatelMerckSarad NepalMerckShitanshi MehtaIndustryShyamprasad Samisetti MerckSrinivas KovvuriLabcorpSunil GuptaIndustrySusheel ArkalaMMS Swathi KotlaIndustryTanvi Gupta PPDVanitha DareedyGileadVishnu KollisettiBMSYaling TengAmgenYoshiko KitagawaONO PharmaWinkle Lu Industry