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Ask Boris about CMC and other FDA plans (Adverse event)

EMR FHIR Transport/BRIDG based repository/ FHIR transport to CDISC standards 


Ballot ItemsOther outputConnectathonWork
Jan 2019


Transcelerate:

  • Adverse event narrative
  • Clinical plan narrative

 PSS for Adverse event and clinical plan

PSS for BRIDG 6.0

PSS ECG Reaffirmation

CRN NIB

CDISC LAB NIB

BRIDG NIB


IDMP and Other resources (ask RIK)
Adverse event

May 2019

ECG Re-affirmation

BRIDG R5.3(SDTM 3.2, NBIA)

CDISC LAB IG

CRN IG

Whitepapers:

  • Site FHIR Server Setup
  • Patient confidentiality



Transcelerate:

  • Adverse event mapping
  • Clinical plan mapping
  • Identify CDISC standards
 CDMH NIB



Clinical plan

Oct 2019


Transcelerate:

  • Connectathon for adverse event and clinical plan






PSS BRIDG 2020
Jan 2020

ResearchStudy - ResearchSubject to maturity level 5




Transcelerate:

  • Real world evidence







May 2020BRIDG R6









Oct 2020











PSS BRIDG 2021
Jan 2021












May 2021BRIDG R7









Oct 2021





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