You’ll imagine that you are the leader of a unit. You’ll need to write an email to your team that gives them directions about the new procedures for remote monitoring.Read question #14 in the FDA guidance(p.23).
- “I am a study monitor and am unable to conduct onsite monitoring visits due to the COVID-19 public health emergency. May I remotely perform the site monitoring visit? What recommendations does the FDA have for how I can remotely perform source document review?”
- Using a “9” concern for results and a “9” concern for people approach, draft a concise email to your team of clinical trial monitors that explains their next steps. Don’t worry if you aren’t a clinical trial expert. You can see this is a BIG change in operations, and as a leader, you must provide direction and comfort to your group. You need to help them adjust their practices and transition from onsite monitoring to remote monitoring. To complicate matters, you not only have to comply with your institutional structures and policies, but you also have to fully comply with the regulatory requirements that govern clinical trials.
- In this email to your team, outline how you are going to change from onsite monitoring to remote monitoring. The email is less about the technical requirements and more about your behavior as a leader. Remember, it’s what you do and say that will help comfort, guide, and unify your approach in these challenging and uncertain times.
- Length: 1-2 pages.
- Use APA (7th edition) for the citations.You must submit a Word document.
Requirements: 2 pages
