Blog — Clinical Pathways

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Investigator

What to Do with Unused IP Shipped to Subjects at Home? UPDATE to FDA’s COVID-19 Clinical Trial Guidance on Dec. 4th

12/17/2020

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The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on what to do with unused investigational product (IP) shipped to study participants’ homes, a more common occurrence during stay at home orders and quarantines during the pandemic. The new question with answer makes it clear that regulations for IP accountability still need to be followed, but that alternative methods to traditional disposition can be considered.

Is it Really Consent? Considerations in Consenting COVID-19 Patients to Clinical Trials

8/11/2020

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During the pandemic, it has become evident that we must continue to consent COVID-19 patients into clinical trials as we work to discover treatment options and better understand other aspects of the disease. Because of isolation restrictions, it is more cumbersome for all involved to conduct the informed consent process as we are accustomed. The investigator or delegate is likely not permitted into the isolation room to discuss the aspects of the trial with the potential subject. This leads to barriers to their ability to see important facial features communicated during a conversation.

CTTI Released New Recommendations for Investigator Qualifications

11/27/2018

The regulations require investigators to have appropriate qualifications, but how to define it is not thoroughly described. Generally, sponsors or CROs have chosen to define qualification as completing training on Good Clinical Practice (GCP). Although having a knowledge of GCP is essential, the current method of training is not effective.