October 2020
The IRB Review
A compilation of information, announcements, & updates for UK Institutional Review Board (IRB) members, research investigators, & others involved with human subject research.
FDA-Regulated Clinical Trials COVID-19 Guidance 

September 21, 2020, the FDA issued guidance for investigators and sponsors regarding the measurement and analysis of COVID-19-related symptoms in clinical trials evaluating drugs to prevent or treat COVID-19 in outpatient adult and adolescent subjects. Since daily assessment of all COVID-19 related symptoms may not be feasible or may be burdensome for subjects, the guidance provides a set of common COVID-19 related symptoms and approach to measurement. The guidance also provides recommendations on endpoint selection and efforts to minimize missing data. It recommends including information in the consent document and process to educate participants on the importance of providing follow-up data even if they choose to discontinue investigational treatment. 

The agency also updated the FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic, originally issued in March. The September update includes question and answers on a clinical trial investigator’s responsibility to review all investigational new drug application safety reports, including reports that will not result in a change to the investigator brochure, informed consent, or protocol and considerations for electronic signatures on clinical trial records, including consent documents, during the public health emergency. 
Please note: Individuals conducting human subjects research must review and comply with the requirements of the VPR’s Resumption of Research Phased Plan before initiating or resuming any in-person research.
LabArchives® Electronic Research Notebook (ERN)
Overview & Demonstration

We are currently scheduling several live webinars for the UK Research community. Please go to our Training Events & News page (click button below) to register for a session convenient for you.

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Upcoming ORI Office Hours
November 11, 2020
11:30 am - 12:30 am
December 8, 2020
1:00 pm - 2:00 pm