Low Compliance Risk
Your study is likely to be short in duration, modest in size and have a stable set of core staff. You probably have a well organized Trial Master File, did a neat job during study start-up and site activation and made scant use of spreadsheets during study conduct. You are also likely to have an excellent project management team - a fortunate situation that is difficult to reproduce for every study.
Areas for improvement are likely to be:
- Removed dependency on email for critical elements of study communication.
- Demonstrating that sites always accessed the latest versions of documents and forms.
- Consistency between what is in site ISFs and your Trial Master File.