Regulatory Binder
Principal Investigator Responsibilities require the PI create, maintains and properly storage of a study file or regulatory binder that contains the required study documents as outline in the GCP SOP 1103 (and associated Guidance documents) entitled "Regulatory files and Subject Records".
The Regulatory Binder will help PIs and research staff, identify, maintain and organize study documents and correspondence in one central location.
- The binder dividers will assist you in creating a binder for each study.
- The guidance documents will assist you as you create the binder,