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Forms 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]

Public reporting burden for this collection of information is estimated to average 1 minute per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0648). Do not return the completed form to this address.