COVID-19 Resources

Policy Updates resulting from COVID-19

There have been recent policies released regarding on-site monitoring and remote access to the EHR on the ORQA Policies page. Please contact Shaunagh Browning if you have any question about these policies

Research Pharmacy has provided the following communications regarding shipping of drugs directly to research participants and submitting investigational product orders to the Research Pharmacy via MedConnect.

Coronavirus and Prescribing of Research Drugs

Coronavirus and Shipping of Research Drugs

Helpful Guidance and Links

• GU IRB Guidance and Update

• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (Updated June 3, 2020)

• OHRP Guidance on COVID-19 April 8, 2020

• Additional Guidance Regarding Alternative Procedures for Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program (CTEP) and NCI Community Oncology Research Program (NCORP) Affected by the Spread of the Novel Coronavirus
• Interim Guidance for Patients on Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP) March 13, 2020

• 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)

• WIRB-Copernicus Group® (WCG) Patient Resource Page

• WIRB-Copernicus Group® (WCG) Resource Center: COVID-19 and Clinical Trial Operations
• Advarra® Coronavirus Guidance: Answers to Your Urgent Questions About the Research Impact of COVID-19
• Advarra® Live Webinar Slides: The Real-World Impact of COVID-19 on Research

• CITI Program Webinar: COVID-19 and Human Research Protection Programs
• CITI Program: Coronavirus (COVID-19) Resources Page
• Notice of Information: Contributing to the Global COVID-19 Crisis Response by Allowing Some NCI-supported Projects to be Redirected to COVID-19-related Research During the Crisis
• Advarra® Restart your Research: Free eLearning to help restart studies impacted by COVID-19