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ERSA Updates and NCI-CIRB Changes

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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  1. ERSA Updates and NCI-CIRB Changes 1

  2. 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/

  3. 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

  4. 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

  5. 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.

  6. NCI CIRB Changes • NCI CIRB studies entered into ERSA • Administratively acknowledged and consent posted (with NCI CIRB approval date only)

  7. IRB Education Fund http://www.ochsner.org/lp/philanthropy/

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