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Study Forms

Administrative Forms

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.

Study-Wide Forms

Adverse Events Form (MS Word, 38K or screen-readable PDF, 68K)

Prior and Concomitant Med (MS Word, 34K or screen-readable PDF, 58K)

Protocol Deviations Core form (MS Word, 46K or screen-readable PDF, 80K)

Serious Adverse Events Form (MS Word, 31K or screen-readable PDF, 769K)

Study Completion (MS Word, 32K or screen-readable PDF, 56K)

Baseline Visit Forms

Visit Checklist (MS Word, 34K or screen-readable PDF, 53K)

Inclusion Exclusion Core Form (MS Word, 29K or screen-readable PDF, 184K)

Demographics Form (MS Word, 32K or screen-readable PDF, 661K)

Medical History (MS Word, 50K or screen-readable PDF, 87K)

Medical History Conventional (MS Word, 54K or screen-readable PDF,184 K)

Vital Signs (MS Word, 33K or screen-readable PDF, 101K)

Physical Exam (MS Word, 73K or screen-readable PDF, 193K)

Randomization and Enrollment Form (MS Word, 32K or screen-readable PDF, 806K)