Memos and Guidance for DCP Clinical Trials Investigators during the COVID-19 Pandemic

COVID-19 is an emerging, rapidly evolving situation. In addition to the information sources listed in the web header, the National Cancer Institute and the Division of Cancer Prevention have issued guidance for DCP investigators during the COVID-19 pandemic. Those materials are consolidated here for convenience:

NCI Central Institutional Review Board (CIRB) Guidance for the New Coronavirus: https://www.ncicirb.org/

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards

MEMORANDUMS

• COVID Minor Deviation Reporting Form (XLSX, 74.84 KB)
  Date: May 8, 2020
• Additional Guidance Regarding Reporting of Minor Deviations for Clinical Trials (PDF, 89.66 KB)  Supported by the NCI DCP Phase 0-2 Cancer Prevention Clinical Trials Program
  Date: March 27, 2020
• Guidance for Collection of Adverse Events Related to COVID-19 Infection (PDF, 41.9 KB)
  Date: March 25, 2020
• Additional Guidance for Clinical Trial Activities Affected by the Novel Coronavirus (PDF, 148.24 KB)
  Date: March 23, 2020
• Interim Guidance for Patients on Clinical Trials Supported by the NCI CTEP and NCORP (PDF, 146.64 KB)
  Date: March 13, 2020
• Interim Guidance for Patients on Clinical Trials Supported by the NCI DCP Phase 0-2 Cancer Prevention Clinical Trials Program (PDF, 83.66 KB)
  Date: March 13, 2020

Last updated: May 8, 2020