More Related Content
What's hot (20)
Viewers also liked (13)
Similar to Final_ºÝºÝߣ deck template_Grace_CR process (20)
Final_ºÝºÝߣ deck template_Grace_CR process
- 1. IRB/WIRB Continuing Review Regulatory Process Improvement Grace Jama-Adan, MPH, CHES Regulatory & Compliance Specialist: Lymphoma WG
- 2. Where are we now? • Continuing Review(n): – FDA regulated review that requires IRBs to conduct review of research at intervals appropriate to degree of risk, but not less than once a year {per 21 CFR §56.108(a)(1) and 21 CFR § 56.109(f)} • Compliance with CTO SOP 8.2: – Use of OnCORE CRA Console to assist with research subject enrollment over last 6 months/year – Failure to obtain appropriate renewal prior to expiration date and patients accrued (OnCORE IRB Lapse Report Run date 10.25.2013) • Clifton Road: 28 studies since 01/01/2013 • VAMC: 6 studies since 01/01/2013
- 3. What have we done well? • 90 day IRB e-reminder to begin renewal process • 60 day announcement of impending expirations during WG meetings by Regulatory Specialist • Improved OnCORE CRA Console subject entry by CRCs/Data Managers/Research Nurses • IRB-Winship biweekly Working Group to highlight unique study submission challenges • OnCORE notification listserv to study team, IDS of continuing review renewal approval receipt
- 4. What are the challenges? • Diffusion of Trial Periodic Summary Information Among PI/CRC/Regulatory: – Summary of Withdraw Accuracy – AE/UP/Death/Deviation/Complaint Instance Matching – Publication & Conference Presentation history/plans – Thoroughness of Western IRB Investigator Reporting – Use of Emory-licensed intellectual property – External Safety Report Reviews (INDSR 90 day window of PI assessment) • Beyond Inter-CTO control: – Lag time in review at IRB (rare, but happens!) – Same-day IRB approvalïƒ IDS, ERMS entry for patient with next-day visit
- 5. What is the plan to address? • CRA Console Key Areas to Ensure are Updated: – Followup Status: Off Txt Reason OR Off Study Reason – Followup Start/Last F-U/Expired Dates – Subject Eligibility: Reason Not Eligible OR Reason Withdrawn – Consent-please notify OnCORE as soon as is possible after subject signs • Pivotal Intra-working group conversations: – Non-therapeutic protocols: Are retrospective and/or prospective reviews occurring? Does chart review/specimen collection count need to increase? – Therapeutic protocols: • Any changes to risk-benefit assessment based on study results? • Vulnerable population identification-pregnant women, prisoners • Members of study team with COI-SFI with Industry Sponsor need to be identified so regulatory specialist is aware • If Enrollment is Closed: Are any subjects completing research-related interventions? If not, study active for LTFU? Is data analysis solely expected to occur going forward? • Have there been any issues that have made enrollment difficult? • If Emory leads a multi-site: are all external site reportable events documented?
- 6. How will progress be measured?(Metrics) • OnCORE IRB Lapse Report Quarterly WG- specific Reviews • OnCORE CRA Console Monitoring of New Enrollment Information received <45 Days before Expiration for IRB submission updating • Minutes Allocation: Working Group Meeting Balanced Regulatory Discussions
Editor's Notes
- #5: WIRB form uniquely asks information about a) changes to local or state laws related to the research, b) PI perception of community attitude towards research, c) any recent deaths or serious injuries in the community outside of this study Also, WIRB will sometimes issue the renewal letter after the date of expiration, because all investigators are sent letters on same day (investigators whose sites all expire same month). Thus, OnCORE cannot be updated with approval letter until 1-3 days after approval has been attained at panel review.
- #7: CRs will be given adequate time, although amendments are also critical and timely. CR conversations are usually quickest of all, but more time needs to be taken to address questions reg specialists may have.