NEW - Memorandum on Additional Guidance for Clinical Trial Activities Affected by the Novel Coronavirus
On April 10, 2023, President Biden signed the bill officially ending the COVID-19 national emergency for the United States. All allowed COVID-19 deviations and reporting requirements are now discontiunued.
The following section will be retained for archival purposes.
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Please find attached a memo providing additional guidance for clinical trials supported by CTEP and the NCORP due to concerns regarding the spread of the novel coronavirus. CTEP and the NCORP are providing additional guidance on alternative procedures that can be used for trials supported by CTEP and the NCORP to address some of the current challenges in providing care to patients in order to mitigate immediate hazards to the patients.
Please distribute this information to the appropriate staff and participating sites in your organization, as needed. Please note that this information will also be sent out by the CTSU to all participating sites in the various CTEP/NCORP trials networks, so some investigators and research staff may receive the notification twice.
In addition, the guidances from FDA and NIH (for grant related items) listed below may also be useful to you in managing cancer clinical trials patients under the current public health emergency.
- FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic
- 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)
We will continue to monitor closely the studies being conducted across all the CTEP/NCORP clinical trials network programs to see if additional accommodations can be made to help maintain continuity of care of patients on trials as much as possible in this challenging situation. Please do not hesitate to contact the Program Director for your specific trials program with any questions/concerns that may arise during this outbreak of the novel coronavirus.
Sincerely,
Meg Mooney, MD, Associate Director, CTEP
Worta McCaskill-Stevens, MD, Director, NCORP, DCP, NCI
