Looking for answers to urgent questions about the research impact of COVID-19?
Advarra stands together with the research community during the COVID-19 crisis. We offer free resources to address the impact of COVID-19 on ongoing clinical trials.
Advarra has compiled the following list of external regulatory guidance documents and other resources to help sponsors, sites, and IRBs remain compliant during this challenging time. This summary is updated as new information becomes available. If you want to receive alerts when we update this page, sign up here for email notifications.
Topics
IRB Guidances and Other Resources Revised
September 23, 2021
- FDA: FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency (August 30, 2021)
- Health Canada: Management of Clinical Trials During the COVID-19 Pandemic: Notice to Clinical Trial Sponsors (May 6, 2021)
- FDA: Assessing COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment (October 16, 2020)
- HHS: Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (October 8, 2020)
- FDA: Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency (June 16, 2020)
- FDA: Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators (June 2, 2020)
- FDA: COVID MyStudies Application (App) (May 29, 2020)
- CITI: Coronavirus Guidance (no version date provided)
- BBK Worldwide: When and What to Submit to the IRB (April 29, 2020)
- HHS: OHRP Guidance on COVID-19 (April 8, 2020)
- OCR: Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (March 30, 2020)
- OCR: OCR Issues Bulletin on Civil Rights Laws and HIPAA Flexibilities That Apply During the COVID-19 Emergency (March 28, 2020)
- NCI: Memorandum on Additional Guidance Regarding Alternative Procedures for Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program (CTEP) and NCI Community Oncology Research Program (NCORP) (March 23, 2020)
- VA: Administrative Hold on Non-Critical, In-Person Interactions With Human Research Subjects in ORD-Funded Studies (March 17, 2020)
- HHS: Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (March 17, 2020)
- NCI: 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)
- VA: ORD Guidance on Human Subjects Protections Issues Related to COVID-19 Concerns: Implementation of Clinical Screening Procedures for VA Research Protocols and Modifying Study Procedures (March 10, 2020)
- HHS: COVID-19 & HIPAA Bulletin Limited Waiver of HIPAA Sanctions and Penalties During a Nationwide Public Health Emergency (March 2020)
- HHS and OCR: Bulletin: HIPAA Privacy and Novel Coronavirus (February 2020)
Sponsor/Site Guidances and Other Resources
June 4, 2021
US:
- FDA: Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (May 28, 2021)
- FDA: Emergency Use Authorization for Vaccines to Prevent COVID-19 (May 25, 2021)
- FDA: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations (May 5. 2021)
- FDA: Resiliency Roadmap for FDA Inspectional Oversight (May 2021)
- FDA: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring FacilitiesDuring the COVID-19 Public Health Emergency (April 14. 2021)
- FDA: Development of Abbreviated New Drug Applications During the COVID-19 Pandemic (April 5, 2021)
- FDA: COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders (March 4, 2021)
- FDA: COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry (March 4, 2021)
- FDA: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants (February 22, 2021)
- FDA: Investigational COVID-19 Convalescent Plasma Guidance for Industry (February 11, 2021)
- FDA: Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency (January 27, 2021)
- FDA: Protecting Participants in Bioequivalance Studies for Abbreviated New Drug Applications During the COVID 19 Public Health (January 15, 2021)
- FDA: Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency (December 4, 2020)
- FDA: Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency (October 28, 2020)
- FDA: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answer (October 23, 2020)
- FDA: Assessing COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment (October 16, 2020)
- FDA: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (September 10, 2020)
- FDA: Coronavirus (COVID-19) Update: FDA Prepares for Resumption of Domestic Inspections With New Risk Assessment System (July 10, 2020)
- FDA: Development and Licensure of Vaccines to Prevent COVID-19 (June 30, 2020)
- FDA: Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing (June 19, 2020)
- FDA: Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency (June 16, 2020)
- FDA: Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators (June 2, 2020)
- FDA: What are Medical Countermeasures? (June 1, 2020)
- FDA: COVID MyStudies Application (App) (May 29, 2020)
- FDA: Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (May 26, 2020)
- FDA: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (May 26, 2020)
- FDA: Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (May 21, 2020)
- FDA: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic (May 11, 2020)
- FDA: Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency (May 11, 2020)
- FDA: Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency (May 11, 2020)
- FDA: Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 6, 2020)
- FDA: Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 4, 2020)
- OCR: Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (March 30, 2020)
- FDA: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act (March 27, 2020)
- NCI: Memorandum on Additional Guidance Regarding Alternative Procedures for Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program (CTEP) and NCI Community Oncology Research Program (NCORP) (March 23, 2020)
- FDA: Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency for Industry and Health Care Professionals (March 22, 2020)
- HHS: Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (March 17, 2020)
- NCI: 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)
Canada:
- Health Canada: Management of Clinical Trials During the COVID-19 Pandemic: Notice to Clinical Trial Sponsors (September 29, 2020)
Estonia:
- Agency of Medicines: Guidance on Clinical Trial Management in the Context of COVID-19 Pandemic (April 28, 2020)
Europe:
- EMA: Human Regulatory Overview: Public Health Threats: Coronavirus Disease (COVID-19) (no version date provided)
- EMA/EC/HMA: Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic (April 28, 2020)
Italy:
- Agenzia Italiana del Farmaco: Management of Clinical Studies in Italy During the COVID-19 (Coronavirus Disease 2019) Emergency (translated from original Italian) (no version date provided)
Spain:
- AEMPS: Exceptional Measures Applicable to Clinical Trials to Manage Problems Arising From COVID-19 Emergency (translated from original Spanish) (March 16, 2020)
UK:
- MHRA: MHRA Guidance on Coronavirus (COVID-19) (updated frequently)
- MHRA: Clinical Trials Applications for Coronavirus (COVID-19) (November 9, 2020)
- MHRA: Advice for Management of Clinical Trials in Relation to Coronavirus (March 12, 2020)
