Our self-assessment series is designed to support clinical research personnel in conducting compliant and high-quality research. These tools are designed to help you proactively identify strengths and areas for improvement at any stage of your study, whether you’re just starting, in the midst of your research, or preparing for monitoring visits or audits.

By regularly utilizing these self-assessments, research teams can enhance quality, maintain compliance with regulatory standards, and contribute to the overall success and integrity of their studies. Choose the self-assessment tool(s) that best fits your needs from the list below:

Data Integrity Self-Assessment

This self-assessment aids investigators and designated study team members in evaluating the Data Integrity of the study. It helps to verify that the data is in compliance with the protocol and may assist in identifying areas of improvement.

Clinical Trial Regulatory Document Self-Assessment

This self-assessment helps investigators and study teams evaluate regulatory documents throughout the clinical trial process. It aims to keep regulatory documentation complete, accurate, and up-to-date. The Clinical Trials Quality Assurance team will incorporate this tool into routine audits to promote ongoing compliance and adherence to regulatory standards at every stage.

Informed Consent Self-Assessment

This self-assessment guides investigators and designated study team members in evaluating the IRB-approved informed consent process. It helps maintain ethical standards and regulatory compliance during the consent process.

Participant Eligibility Self-Assessment

This self-assessment assists investigators and designated study team members in evaluating the IRB-approved eligibility screening process. It supports consistent application and documentation of participant selection criteria.

Qualifications and Documentation Self-Assessment

This self-assessment aids investigators and designated study team members in evaluating qualifications and delegation documentation. It helps verify that team members are appropriately qualified and that their roles and responsibilities are clearly documented.

The self-assessments are provided in a fillable PDF format, allowing users to enter information electronically using Adobe Acrobat Reader. Alternatively, you can print a copy of the form and fill it out by hand.

IMPORTANT: For full functionality of the form, use the latest version of Adobe Acrobat Reader and avoid completing the form online within your web browser using an alternate PDF viewer. Before starting the assessment, save the form to a UNC drive without opening the file online within your web browser. Click here for download tips. Once you have saved the form, locate the saved form and right-click to open with Adobe Acrobat Reader. Follow the instructions at the top of the form to complete the assessment.