SOCRA Study Guide 2026

The Principal Investigator is responsible for ensuring all adverse events (AEs) are properly documented in the source records and reported to the sponsor. The specific timelines and methods for reporting both serious and non-serious AEs are dictated by the clinical trial protocol. Investigators report SAEs to the sponsor, not directly to the FDA.

Obtaining consent after procedures begin violates the fundamental GCP principle of informed consent prior to any trial-related activities and constitutes a serious violation.

The acronym ALCOA-C (or ALCOA+) refers to the standards for high-quality data. It stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. 'Complete' means that the data includes all pertinent observations for that subject, without missing information.

ICH E6(R2) and 21 CFR Part 312 place primary responsibility on the sponsor to conduct adequate monitoring to ensure data quality and subject protection.

FDA Form 483 is issued by an FDA investigator at the conclusion of a facility inspection and documents conditions or practices observed that may constitute violations of applicable regulations. The recipient is expected to respond with a corrective action plan.

According to FDA regulations (21 CFR 56.107), an Institutional Review Board (IRB) must have at least five members. This minimum number ensures a diverse range of expertise and perspectives are present during the review of research protocols. A larger, diverse committee helps to provide a thorough and unbiased ethical and scientific review of studies involving human subjects.