Coronavirus Guidance

DCTD CTEP and NCORP Guidances

• Interim Guidance for Clinical Trial Activities Affected by the Novel Coronavirus (3/13/20)
• Additional Guidance Regarding Alternative Procedures for Clinical Trials Supported by NCI CTEP and NCORP Affected by the Spread of the Novel Coronavirus (3/23/20)
• CTEP/NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection (3/25/20)
• New Guidance for Shipping Oral IND Agents to Clinical Trial Subjects (effective 01-JAN-2022)

These guidelines complement and support the NCI CIRB Guidance for the novel coronavirus.

FDA Guidance

• FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic

NIH Guidances

• Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (Notice Number: NOT-OD-20-87)
• Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19 (Notice Number: NOT-OD-20-86)
• NIH Website on COVID-19 Treatment Guidelines
  • COVID-19 Treatment Guidelines Panel's Statement on Therapies for High-Risk, Nonhospitalized Patients with Mild to Moderate COVID-19

Additional important guidance may be added as it becomes available.