Which party is NOT typically involved in the drug approval process?

Study for the Certified Clinical Research Coordinator exam. Engage with flashcards and multiple choice questions, complete with hints and explanations. Prepare for your exam day!

The marketing manager is typically not involved in the drug approval process. The drug approval process primarily involves entities focused on the safety and efficacy of a drug, as well as ensuring regulatory compliance. The sponsor, which is usually a pharmaceutical company, is responsible for initiating and funding the clinical trials and is heavily involved in the submission of data to regulatory bodies. The researcher conducts the clinical trials to gather data on the drug's performance and side effects. The Institutional Review Board (IRB) is critical in reviewing and overseeing studies to protect the rights and welfare of study participants.

In contrast, the role of a marketing manager is more aligned with post-approval activities, such as promoting the drug and strategizing on its market entry after it has received regulatory approval. Therefore, while the marketing manager plays a vital role in the overall lifecycle of a drug, they are not part of the formal drug approval process itself.

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