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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)

kkundarapu@loxooncology.com

Satheesh Avvaru (Alexion)

satheesh.avvaru@alexion.com

Nicola Newton (PHUSE, Project Assistant)

nicky@phuse.global

Objectives & DeliverablesTimelines

iADRG template, completion guidelines and 2 examples

Q2 2023


Status
colourBlue
titleCurrent Status
Q2 2023

  • Incorporated the  PHUSE Leadership and Deliverable feedback into iADRG
  • Proof reading complete for the iADRG Documents 
  • iADRG track to be published in July 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 SchaferBayerProject MembersOrganisationKapil Arnand ParexelLokesh UsherIndustryMathura RamanathanLabcorpMichael MarroquinPharmaStatMichael Wise Apellis Micky Salgao-GomezPharmaStatMithun RangaIndustryMrudula MogallaAvance Clinical Pranab MitraTakedaPriyanka Pollarine BiogenRaghava RegullaBayerRandi McFarlandEphicacySameer SaxenaBayerSandy VanPelt NguyenPfizerSapan PatelMerckSarad NepalMerckShitanshi MehtaIndustryShyamprasad Samisetti MerckSrinivas KovvuriLabcorpSunil GuptaIndustrySusheel ArkalaMMS Swathi KotlaIndustryTanvi Gupta PPDVanitha DareedyGileadVenkata Reddy







Objectives & DeliverablesTimelines

iADRG template, completion guidelines and 2 examples

Q2 2023
Vishnu KollisettiBMSYaling TengAmgenYoshiko KitagawaONO PharmaWinkle Lu Industry