The NCI CIRB is monitoring the COVID-19 (coronavirus) outbreak and is working closely with NCI as new information arises. Currently, the NCI CIRB is fully functional and operating at our standard capacity. We do not anticipate any negative impacts on our procedures or timelines due to the outbreak.
This page will be used a central location for all COVID-19 related announcements that pertain to the NCI CIRB, covered clinical studies, or stakeholder responsibilities. It has been developed as a single collection point for all COVID-19 information to help the research community when addressing the outbreak of COVID-19 within the context of CIRB approved clinical trials. Please refer to this page daily to keep apprised of COVID-19 developments and announcements.
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic - Guidance for Industry, Investigators, and Institutional Review Boards (Updated July 2, 2020)
- Updated CIRB Continuing Review Application For COVID-19 Reporting (Updated June 1, 2020)
- A revised set of Frequently Asked Questions Regarding COVID-19 and the CIRB (Updated April 22, 2020) and Frequently Asked Questions Regarding Remote Consent Procedures (Updated April 22, 2020) has been developed to help the research community when addressing the outbreak of COVID-19 within the context of CIRB approved clinical trials.
- Notice: Revised Remote Consent Procedures FAQs Due to COVID-19
- OHRP Guidance on COVID-19 (updated April 8, 2020)
- Additional Guidance Regarding Reporting of Minor Deviations for Clinical Trials Supported by the NCI DCP Phase 0-2 Cancer Prevention Clinical Trials Program (updated March 27, 2020)
- Memorandum on Additional Guidance for Clinical Trial Activities Affected by the Novel Coronavirus (Updated March 23, 2020)
- Memorandum on Interim Guidance for Patients on Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP) (Updated March 13, 2020)
- Interim Guidance for Patients on Clinical Trials Supported by the NCI DCP Phase 0-2 Cancer Prevention Clinical Trials Program (Updated March 13, 2020
Additional information is available on the CTSU website. Announcements from NCI and the LPOs will be posted as they are received. Check the News & Announcements section for messages and a link to the COVID-19 Information page (login to members’ website required).
Additional information from NCI is also available on the CTEP homepage.
Updated June 1, 2020