Sample case report form clinical trials

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NIH Policy and Guidance. Study Accrual and Retention Plan Template. If NCCIH requires that study investigators submit a final protocol document , the protocol must be submitted to the NCCIH Program Director prior to study implementation using one of the protocol templates listed below. Clinicalstudies use a series of case report forms to collect data in a consistent manner. The forms below are commonly used in clinical studies and can be customized to meet the needs of the specific clinical study.

Investigators may need to create additional forms to capture all data elements required in the clinical study. Sample form to record participant-specific adverse events. It should be modified to match the protocol and DSMP. Demographics [33KB Word file ]. May be modified to meet individual study needs. Provides a framework for documenting the consent discussion and process with a potential study participant. May be modified to suit the needs of the clinical research study.

Sample checklist that is used to ensure that participants meet eligibility criteria. Must be modified to meet individual study needs. Medical History a [36KB Word file ]. Medical History b [37KB Word file ]. Physical Exam [42KB Word file ]. Randomization and Enrollment [36KB Word file ].

Sample form to record that a participant was randomized. Note: this form is not intended to capture randomization assignment. Sample form to record a serious adverse event. May be modified to meet individual study needs or IRB requirements.

Study Completion [33KB Word file ]. Checklist which may be used to ensure that all assessments scheduled to be done at the baseline visit have been completed. Checklist which may be used to ensure that all assessments scheduled to be done at on-study visits have been completed. Vital Signs [34KB Word file ]. Sample form to record participant vital sign information. Provides instructions for consistent study procedure implementation and data collection across participants and clinical sites.

Provides instruction on how to number draft and final documents. Version control should be used for clinical research documents, including the protocol, consent document, case report forms, and Manual of Procedures. Supports the documentation of changes from one institutional review board IRB -approved version of a protocol to the next.