Clinical Research Agenda Sample

CRA Sample Agenda

On the first visit to a clinical trial site, the CRA should prepare the site by sending an agenda for the visit. In this way, the site is able to prepare by having all relevant information accessible for inspection. An agenda should be prepared as such:

To: The Chief Investigator

On December 10, 2015 I will be visiting your site to conduct an audit and monitoring of activities. I have provided you with an agenda of the activities I desire to accomplish during this visit. The following agenda outline these activities.

The Auditing

1. Auditing trial related activities and documents

2. Auditing current participant information and documents

3. Auditing trial related activities to ensure that they were conducted properly and recorded accurately. This will be done in accordance with:

• Protocol
• Sponsor’s SOPs
• GCP
• All applicable regulatory requirements (Center for Cancer Research National Cancer Institute, 2015).

Monitoring

1. Monitoring will be performed in order to ensure that the study is conducted, recorded and reported in accordance with:

• Protocol,
• SOPs,
• GCPs,
• All applicable regulatory requirements (Center for Cancer Research National Cancer Institute, 2015).

2. Monitoring will be performed in order to determine that protocols follow the data saety and monitoring process plan of the site

3. Monitoring will include the progress and documentation of the trial for reporting to sponsor and or IRB (Center for Cancer Research National Cancer Institute, 2015).

As an initiation visit, I am seeking to gather information for compliance and look forward to approval of the site. I will bring with me forms for reporting such as the logs for monitoring and signatures as well as a copy of the monitoring plan. I will need access to the drug, binders, test tubes, regulatory binder, etc.

I would like to thank you and your staff in advance for making my visit as efficient and easy as possible. I am sure that this will be the start of a good working relationship.

References

Center for Cancer Research National Cancer Institute. (2015). Monitoring and Auditing of Clinical Trials. Retrieved from Center for Cancer Research National Cancer Institute: https://ccrod.cancer.gov/confluence/download/attachments/71041052/Monitoring_auditing.pdf

Photo by National Cancer Institute on Unsplash