- The Duke COVID-19 Resources for Clinical Research page on the DOCR web site is the best place to find comprehensive, up-to-date information regarding COVID-19 resources for clinical researchers.
- FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency - Updated AUG 30, 2021
- The FDA established an email address for questions regarding clinical trial conduct during the COVID-19 pandemic:
Earlier Guidance Issued by the DUHS IRB Regarding COVID-19:
| March 11, 2020 | Memo sent to the DUHS research community regarding COVID-19 and research at Duke. |
| April 1, 2020 | One-Page Summary of FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. |
| April 1, 2020 | Common examples of when to submit an Amendment to the IRB, given COVID-19 considerations. |
| April 30, 2020 | The IRB's policy on "COVID-19 and Consent for Research at Duke" The purpose of this policy is to provide guidance from the DUHS IRB to Duke’s research community regarding the consent process during the COVID-19 pandemic. |
| September 8, 2020 | Updated IRB Guidance on Changes to Consent Process during the COVID-19 Pandemic This document provides further guidance from the DUHS IRB regarding the need for an Amendment when changes are made to the consent process or platform. |
| September 21, 2020 | DUHS IRB's summary of changes to the “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” that was revised on September 21, 2020. This document is not to be considered a summary of all changes to the guidance but only representative of the most relevant changes. |