Manage study documentation
- As it is often unpredictable when your project will be audited, it is best to manage your project’s documentation as if you might be monitored or inspected at any time.
- The Partners QI Program’s Regulatory Binder is an excellent tool to support you in properly organizing your regulatory documentation. Be sure to keep paper as well as an electronic copies of all IRB-related documents.
- Detailed guidance about properly organizing subject files may be found in the following online training.
- Have all regulatory and subject-related information properly documented and remember: if it isn’t documented, it didn’t happen.
▪ Clinical Research Program Spotlight Series: Developing a Peer to Peer Auditing Program
▪ Good Clinical Practice in Research at an Academic Research Institution
▪ IRB and QI Roundtables