Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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Prepare for the ACRP Certified Professional Exam with our comprehensive quiz. Elevate your clinical research skills with targeted flashcards and multiple-choice questions. Enhance your readiness with detailed explanations and insights for improved performance!

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Which of the following is NOT a recommendation that can be made by a Data and Safety Monitoring Board?

  1. Continue the trial

  2. Modify the trial

  3. Stop the trial

  4. Initiate marketing of the drug

The correct answer is: Initiate marketing of the drug

The recommendation to initiate marketing of the drug is not within the purview of a Data and Safety Monitoring Board (DSMB). The primary role of a DSMB is to evaluate the data collected during a clinical trial to ensure the safety and well-being of participants, and to monitor the trial's integrity. Their recommendations typically focus on whether to continue the trial, modify aspects of it for safety or effectiveness reasons, or stop it altogether if significant safety concerns arise. The actions taken by a DSMB are strictly related to the conduct of the trial, not to the commercialization or marketing of the product being studied. Marketing decisions are made after the completion of a trial and are typically in the hands of regulatory authorities and the sponsors of the drug development process. Therefore, initiating marketing is outside the scope of what a DSMB can recommend.