1 / 8

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.

lynda
Télécharger la présentation

ERSA Updates and NCI-CIRB Changes

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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/

More Related