Site Signature Log - Delegation of Authority Log (MS Excel, 47K or screen-readable PDF, 294K) A record of all study personnel and their specific responsibilities, signatures, and dates of involvement during the conduct of a clinical research study.
Note to File Template (MS Word, 20K) - Used by clinical site staff to document protocol deviations or other discrepancies identified during the conduct of the clinical research study, and plans for resolution/prevention.
Sample Visit Flow and Schedule (MS Word, 25K) – the visit schedule tracks an individual subject/participant’s progress through the study and helps to ensure that visits take place during the protocol-specified timeframe. The visit flow provides an overview of the activities that take place at each study visit, and may be customized for each study site.
Study Drug/Investigational Product Tracker (MS Excel, 12K) - Used to track study drug/investigational product disposition and accountability by the clinical research site. For multi-site studies under an investigational new drug (IND) application, this tracker could be used by coordinating centers to track the overall distribution of investigational product.
Study Drug/Investigational Product Compliance Log (MS Word, 30K) - Used to track study drug/investigational product disposition and accountability for each individual subject/participant. This form may be used to track protocol adherence via amount dispensed and returned and is designed to be used in conjunction with the Study Drug/Investigational Product Tracker. May also be used to track amount destroyed.