Step 3: Monitoring a Cancer Prevention Clinical Trial
Monitoring Visits
At least once a year, all lead organizations receive a monitoring visit by a Westat clinical research associate. Interim visits can be scheduled as well, particularly if the site is experiencing rapid accrual or protocol deficiencies. The visits usually take 2 or 3 days and are scheduled about 6 weeks in advance.
Site requirements at the time of the visit are:
- Site monitoring sign-in log
- PID logbook
- Case report forms notebooks
- Binders with copies of signed informed consents for all participants
- Source documentation such as clinic charts, shadow files, and hospital charts
- Regulatory documents
- Appointment to meet with site pharmacist if audit is to be performed
- Quiet, well lit area for monitor's uses each day
DCP's Study Site Monitoring Manual, Section 9 (pdf, 38kb), describes the three kinds of site visits conducted by NCI's contractor, Westat Clinical Research Associates.
The purpose, scheduling, requirements, conduct, and follow up activities are discussed for:
- Initiation visits
- Annual or interim visits
- Closeout visit
Site initiation visits are discussed in Step 2, Start-up Activities. The closeout visit is discussed in Step 5, Final Report and Site Visit.
