Certified Clinical Research Associate (CCRA) Practice Exam 2026 – Complete Preparation Guide

Question: 1 / 400

Which of the following is a requirement for investigators regarding study records?

Share them publicly after the trial

Retain them for specified periods

Retaining study records for specified periods is a fundamental requirement for investigators in clinical research. This ensures that there is an adequate archive of all essential study documentation, including protocols, case reports, informed consent forms, and any correspondence related to the trial. The retention period is often dictated by regulatory agencies, sponsor requirements, and institutional policies, typically lasting several years after the study's completion. This archival practice serves multiple purposes: it facilitates audits and inspections, allows for the verification of data integrity, and ensures the availability of information for potential future analyses or investigations.

Other options, such as sharing records publicly after the trial, while beneficial for transparency, do not capture the core regulatory requirement. Similarly, updating records periodically is not a mandated frequency, nor is sending them directly to the FDA part of the standard protocol for conducting studies. The focus remains on the retention and proper organization of records, which ultimately upholds the integrity of the research and protects the rights of participants.

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Send them directly to the FDA

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