An official website of the United States governmentForms and Logs
An A to Z repository of forms, logs, and checklists to inform clinical study start-up and conduct.
Adverse Event Forms [24KB Word file]
Baseline Visit Checklist [32KB Word file]
Delegation of Authority Log [1.1MB Word file]
Demographics Form [33KB Word file]
Documentation of Informed Consent Summary Sheet & Template [1MB Word file]
Essential Regulatory Docs Guidance and Binder Tabs [4.5MB Word file]
FDA Document History Log [1MB Word file]
Guidelines for Developing a Manual of Operations and Procedures (MOP) [170KB Word file]
Inclusion/Exclusion Criteria Sample Checklist [34KB Word file]
Independent Monitoring Committee Report Sample Document [314KB Word template]
Informed Consent Checklist [35KB Word file]
Investigational Product Accountability Log: Subject Record [1MB Word file]
Investigational Product Accountability Log: Stock Record[1MB Word file]
Medical History (a) Form [36KB Word file]
Medical History (b) Form [37KB Word file]
Monitoring Visit Log [1MB Word file]
NCCIH Document History Log [1MB Word file]
Note to File Form [29KB Word file]
On Study Visit Checklist [35KB Word file]
Physical Exam Sample Form [42KB Word file]
Protocol Amendment Summary of Changes Checklist [1MB Word file]
Prior & Concomitant Medications Form [24KB Word file]
Protocol Deviation Tracking Log [1MB Word file]
Quality Management Subject Review Tool [1.1MB Word file]
Quality Management Study-wide Review Tool [1.1MB Word file]
Randomization & Enrollment Sample Form [36KB Word file]
Regulatory Binder Checklist [1.1MB Word file]
Serious Adverse Events Form [1MB Word file]
Site Screening & Enrollment Log [1MB Word file]
Specimen Tracking Log [1MB Word file]
Study Completion Form [33KB Word file]
Training Log [1MB Word file]
Unanticipated Problem (UP) Form [1MB Word file]
Version Control Guidelines [543KB PDF]
Vital Signs Sample Form [34KB Word file]