1. Send a list of subject IDs and indicate the status if they are screen failures, in screening phase or randomized/enrolled. Do not include subject names or other PHI at this time.
2. Ensure there will be available space to review study documents during the study review (quiet, private, access to electrical outlets).
3. Have all study and subject documents, binders, and files available at time of review.
4. Study material should be maintained in a clear and organized manner, preferably in chronological order. Documents can be provided in hard copy or electronically. Whether a study document is electronic or paper, the reviewer must have access, ensure they exist and are reliable and stored safely.
5. A designated member of the research team that is knowledgeable in all aspects of the project must be available to answer questions and retrieve files during the entire site visit.