The Human Research Protection Program provides these templates and tools to promote increased adherence with Federal, State, and Institution Policy. Baystate voluntarily applies the International Conference on Harmonization (“ICH”) Good Clinical Practices (“GCP”) Guidelines (sometimes referred to as “ICH-GCP” or E6) to the extent they are compatible with FDA and DHHS regulations.
Creating your regulatory folder/binder:
Create tabs for each section listed above and place the appropriate documents in each corresponding section in a binder. Be sure to label the outside of the binder (cover and spine) with the protocol number, PI name, and study site. Use multiple or master binders to maintain documentation if necessary.
All Baystate Health System human subject research studies are subject to routine audits by the Human Research Protection Program and may also be reviewed by external entities such as the study sponsor or government agencies.
Often sponsors will provide a regulatory binder. When a sponsor provides a binder it may be lacking one or more of the sections identified in this document. The investigator is responsible for ensuring all sections identified in this document not provided by the sponsor are added to the binder.