SOCRA CCRP Practice Exam

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What three components of AE documentation should CRAs monitor?

Ensure AEs are recorded in study files and medical record
Make sure financial documents are in order
Check the temperature of the storage units
Monitor the number of participants regularly attending the study

The correct answer is: Ensure AEs are recorded in study files and medical record

CRAs should monitor the documentation of adverse events (AEs) in the study files and medical records. This ensures that any AEs reported by participants are accurately recorded and tracked. Options B and C are incorrect as they do not pertain to AEs or documentation, and Option D is incorrect as it does not specifically pertain to AE documentation. It is important for CRAs to closely monitor AE documentation as it helps to ensure participant safety and adherence to regulatory guidelines.