Rather than wait until the end of the semester, teacher and I are offering the following opportunity to earn extra credit. We are aware of the challenges many of you are facing, and know the importance you put on achieving a high grade in your academic endeavors.

As many of you are aware, the FDA released a COVID-19 Guidance Document on 3/17/20 that not only acknowledges the challenges faced by staff, PIs and IRBs but most importantly the participants in our clinical trials. It is not common for the FDA to release a guidance document without first requesting public feedback; however, as we all know these are not normal circumstances.

For an extra 50 points, your assignment is to draft a 2-3 page paper which will describe actions that a site, sponsor, (including the monitoring plan) and IRB, if applicable may take to mitigate risks, and to ensure patient safety in the following real-life scenario.

Background: Focus on a clinical study in which non-cancer participants had blood samples taken with the goal to detect cancer. Once the participant is diagnosed with cancer, they are required to return to the clinic to have additional samples taken before they begin treatment for their cancer. Please consider this is not a treatment study but a diagnostic trial.

Review the guidance document and formulate what restrictions as a sponsor you would implement for the participants, the monitors and the monitoring plan, any restrictions a site may impose to participants, and also include the role of the IRBs, if applicable. And why you are implementing the restrictions.

As you read the Guidance document keep in mind its focus on patient safety in light of  COVID-19, and societal mandates in place, i.e., social distancing and shelter in place.

You do not have to use APA formatting; however, please include a background or introductory paragraph, describe the actions to be taken per role (sponsor, site and IRB, if applicable), and include a closing statement or paragraph.

You will be graded on organization, grammar, and evidence of how well you articulate your understanding of the Guidance and how it impacts clinical trial operations during the COVID-19 pandemic. 

The Guidance document is posted here and is also available in previous readings:

• Please read the attached FDA Guidance for COVID-19. (published 17Mar20, without public input and amended on 27Mar20)https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic (Links to an external site.).

• Additional information is included: https://sites.veeva.com/blog/going-digital-with-remote-monitoring-key-considerations/