A research team’s deliberate and planned review of their own study documents and processes to verify protocol adherence and compliance to policy and regulations is known as a Self-Assessment. Conducting this internal self-assessment review of study procedures and documentation is a recommended best practice and supports participant safety and rights protection as well as increasing data integrity and reliability. Self-assessments can be done at any time point during the study or used to prepare for quality assurance visits from a monitor or auditor. The extent and nature of the self-assessment review should be planned for a specific study. When developing the plan, the research team should consider factors such as study complexity, risk level, and enrollment pace.
These tools are available to assist the research team with conducting Self-Assessments in a deliberate and planned manner. All Self-Assessments should be documented and these tools provide a systematic documentation process. Research teams are encouraged to develop their own tools if there are other study-specific procedures that could benefit from Self-Assessments. Keep these completed Self-assessment forms as documentation of on-going oversight of your monitoring of the conduct of the study.
The Overview and Instructions provides general information on what self-assessments are, their value and place for data integrity and participant safety. Research teams are recommended to start with this document to understand best practices.
The Review Plan form is designed to document the overall plan for self-assessments for the study as a whole. This form also functions as a log documenting completed self-assessments and should be updated as necessary to meet the needs of a specific study.
The Informed Consent tool is designed to be a starting point on consent documentation and process self-assessment and should be updated as necessary to meet the needs of a specific study. Best practice is to review all informed consents.
The Participant Eligibility tool is designed to be a starting point on eligibility criteria review and documentation self-assessment and should be updated as necessary to meet the needs of a specific study. Best practice is to review eligibility criteria for all participants but each participant reviewed should have their own form.
The Protocol Adherence tool is designed to be a starting point on protocol adherence self-assessment and should be updated as necessary to meet the needs of a specific study. Depending on the length of an individual’s study participation and other factors, including risk, and complexity of study design, it might make sense to review participants early and often in their enrollment. For other studies, it might make sense to review adherence when a participant has completed data collection.It is at the research team’s discretion the number of participants to review for protocol adherence but each participant reviewed should have their own form.