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Key Elements

Stratification Guide

FAQs

Clinical Research Forms

I. Informed Consent

                 A. Is the correct, up-to-date consent form, including all amendments and risk assessments, appropriately signed and witnessed by each participant?

                 B. When participants are contacted, do they agree that the consent process adequately prepared them for what their participation actually entailed?

II.  Confidentiality

                 A. Are there appropriate measures in place to ensure the confidentiality of research data?

                                  1. Paper records

                                  2. Computer

III.  Safety Monitoring/Adverse Events

                 A. What safety monitoring is performed?

                 B. How is performance of safety monitoring documented?

                 C. When safety issues are identified, how are they addressed?

                                  1. When adverse events are identified, are they reported appropriately?

IV.  Withdrawal/Accrual Statistics

                 A. How many (what fraction of) participants have withdrawn from the study?

                 B. Are the reasons for withdrawals recorded?

                 C. Do these reasons suggest any issues with the consent process or safety                  monitoring?

                 D. Are accrual goals being met?

V. Experimental Design

                 A. Is eligibility (inclusion/exclusion criteria) of each participant documented?

                 B. Was the specified intervention/observation performed?

                 C. Were the specified outcome measures recorded?

 

 

Key Elements for Monitoring Adherence to Human Subjects Research Protocols

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