Ersa updates and nci cirb changes
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ERSA Updates and NCI-CIRB Changes. 1. ERSA Updates. Current Agenda enhancements Coming soon…October 31 st Ability to send final agenda via ERSA (rather than email) Reviewers forms incorporated electronically in ERSA http://w8versats/ersadev2/. ERSA Updates.

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ERSA Updates and NCI-CIRB Changes

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Ersa updates and nci cirb changes

ERSA Updates and NCI-CIRB Changes

1


Ersa updates

ERSA Updates

  • Current

    • Agenda enhancements

  • Coming soon…October 31st

    • Ability to send final agenda via ERSA (rather than email)

    • Reviewers forms incorporated electronically in ERSA

      http://w8versats/ersadev2/


Ersa updates1

ERSA Updates

  • Coming Soon – November and December 2013

    • New internal workflow

    • Updated applications for all projects

      • New Study

      • Amendment

      • Continuing Reviews

      • Protocol Events

    • Enhanced reporting


Nci cirb changes

NCI CIRB Changes

  • CIRB reviews Phase 3 adult clinical treatment trials and Pilot, Phase 2, and Phase 3 pediatric clinical trials

  • August 2013 - Moved to Independent Model

  • NCI –CIRB is the sole IRB of Record -responsible for both study review as well as review of local context considerations for enrolled institutions


Nci cirb changes1

NCI CIRB Changes

  • Two Key Local Responsibilities

    • Ochsner has the responsibility to report to the CIRB potential unanticipated problems or serious or continuing noncompliance. The CIRB reviews, makes a final determination, and reports to the Federal regulatory agencies, if necessary.

    • Ochsner has the responsibility of merging the CIRB-approved local boilerplate text into the CIRB-approved consent document. No further CIRB review is required because both components are already CIRB-approved.


Nci cirb changes2

NCI CIRB Changes

  • NCI CIRB studies entered into ERSA

  • Administratively acknowledged and consent posted (with NCI CIRB approval date only)


Irb education fund

IRB Education Fund

http://www.ochsner.org/lp/philanthropy/


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