Good Clinical Practice (GCP) Practice Exam

Question: 1 / 400

What is the purpose of a Contract Research Organization (CRO)?

To self-fund clinical trials

To recruit participants for clinical trials only

To perform trial-related duties on behalf of the sponsor

The primary purpose of a Contract Research Organization (CRO) is to perform trial-related duties on behalf of the sponsor. This encompasses a wide range of services that support clinical research, including study design, data management, regulatory affairs, site management, and coordinate logistics. By outsourcing these responsibilities to a CRO, sponsors can leverage the specialized expertise and resources of the organization, ensuring that trials are conducted efficiently and in compliance with regulatory requirements.

CROs play a crucial role in the clinical development process because they provide the necessary infrastructure and knowledge required to navigate the complexities of clinical trials. This allows sponsors, often pharmaceutical or biotech companies, to focus on their core activities such as drug discovery and development without being bogged down by the operational aspects of conducting a trial.

Other potential options, such as self-funding clinical trials or solely recruiting participants, do not encompass the full scope of what a CRO does. Additionally, while CROs may offer some guidance related to regulatory and compliance matters, providing legal advice is not their main function and typically falls within the domain of legal professionals.

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To provide legal advice to sponsors

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