The Study Binder is often the first item reviewed during audits and inspections. The Study Binder is an important component in the conduct of a trial and can be divided into one or more binders if needed; however, it is important to know where all documents are located. The binder should contain all study-specific and essential documents, filed in a manner to allow easy access and evaluation of the conduct of a trial.
Tips for organizing the binder:
- Create tabs for each sections
- File documents into study binder as soon as they are received
- Documents should be grouped by type, for example: Protocol and Amendments, REB approval/Correspondences, Informed Consent Form, Qualifications of Staff, Study Medication, etc.
- Place most recent version of a document at the front of each section