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Updates to ERSA System and NCI-CIRB Changes: Important Enhancements and Responsibilities

The latest updates to ERSA include enhancements to the agenda management system, allowing users to send final agendas via ERSA instead of email. Significant changes to how projects are reviewed and authorized have been introduced, with new workflows for study applications, amendments, and continuing reviews. The NCI-CIRB has also transitioned to an independent model, assuming responsibility as the sole IRB of record for various clinical trials. Critical local responsibilities have shifted to institutions like Ochsner, including reporting compliance issues and merging approved documentation.

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Updates to ERSA System and NCI-CIRB Changes: Important Enhancements and Responsibilities

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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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