SOCRA CCRP Practice Exam

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What is the purpose of MEDWATCH Form 3500?

For healthcare professionals to apply for drug trials
For volunteers to sign up for clinical trials
To report adverse events found in clinical care by healthcare professionals
For FDA notification of new drug formulations

The correct answer is: To report adverse events found in clinical care by healthcare professionals

MEDWATCH Form 3500 is used to report adverse events found during clinical care. This form is not used for healthcare professionals to apply for drug trials (option A) or for volunteers to sign up for clinical trials (option B). Additionally, this form is not used for FDA notification of new drug formulations (option D), as there is a separate process for drug approval and notification. It is specifically designed for healthcare professionals to report any adverse events or reactions related to drugs or medical devices.