For participants discontinuing participation in a study because of a serious adverse event (SAE) or pregnancy, which of the following are correct? A. There should be an attempt to... For participants discontinuing participation in a study because of a serious adverse event (SAE) or pregnancy, which of the following are correct? A. There should be an attempt to follow up the outcome of the pregnancy to term in cases of women discontinuing because of pregnancy. B. There should be an attempt to complete any final evaluations required by the study protocol. C. There should be an attempt to perform other medical evaluations to try to determine the cause of the serious adverse event (SAE) and its possible relationship to the study intervention. D. The serious adverse event (SAE) should be marked as resolved on the date of discontinued participation since the participant may not be evaluated again in the future. E. A, B, and C only F. All of the above are correct. Read more

Understand the Problem

The question is asking which statements regarding the procedure for participants discontinuing a study due to serious adverse events or pregnancy are correct. It is looking for a reliable understanding of protocol adherence in clinical studies.

More Information

Following up on a pregnancy outcome and completing final and additional evaluations are key to understanding the full impact of the intervention or event. The SAE should not be marked as resolved merely because participation has ended, as this might overlook further necessary observations.

Tips

A common mistake is assuming an SAE is resolved upon discontinuation, ignoring the need to investigate its cause further.

Sources

• Answers to - Class Ace - classace.io