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How are adverse events (AEs) documented?

  1. In a separate AEs journal

  2. Internally, within the research team only

  3. In AE CRF for sponsor or other study collection mechanism and in medical record

  4. On social media for transparency

The correct answer is: In AE CRF for sponsor or other study collection mechanism and in medical record

Adverse events (AEs) are documented for record-keeping and reporting purposes. Option A, a separate AEs journal, may not be accessible to all parties involved in the study and may not be consistently updated. Option B, documenting AEs within the research team only, does not allow for reporting to the sponsor or other parties. Option D, on social media, is not a reliable or official means of documenting AEs. Therefore, documenting AEs in AE CRF for the sponsor or other study collection mechanism and in the medical record is the most comprehensive and accurate approach for reporting and record-keeping.