Do you have a monitoring policy and process for your clinical trial site?

If not, you need to write one.

Often, monitoring visits are extremely inefficient interactions. The CRA arrives and things are not ready for them. The study coordinator is interrupted throughout the day with requests for documents or with questions.

Different study types or therapeutic areas may require different approaches, but it is worth everyone’s time to have a written policy that is shared with the CRA prior to the start of the study.

Clearly outline your process for scheduling monitoring visits including the process for notifying of a cancellation. Document the steps that will be taken when the monitor arrives and checks in. Ensure that your internal processes are set up to have everything that the CRA will need, and all issues have been addressed from previous visits prior to this visit.

Schedule a specific time of day towards the end of the visit to review corrections and answer questions. Unless there is an emergency, there shouldn’t be interruptions throughout the day.

Message to both CRAs and sites – share your preferred processes for monitoring visits. We can all learn from each other.

What could make a monitoring visit more efficient for you?