ICH Good Clinical Practice (GCP) For Certified Clinical Research Coordinator (CCRC) Practice Exam

Before initiating the clinical trial(s), what should the sponsor submit to the appropriate authority(ies)?

Required application(s) for review, acceptance, and/or permission to begin the trial, dated and identifiable A general verbal notice to regulatory authorities The final results after completion The subject consent forms

Correct Answer:

Required application(s) for review, acceptance, and/or permission to begin the trial, dated and identifiable

Explanation:

Regulatory authorization must be obtained before starting a trial. The sponsor submits the required written applications for review, acceptance, and permission to begin the study, and these submissions must be dated and identifiable so authorities can track and approve the trial. Verbal notices aren’t sufficient, final results aren’t available until after completion, and while consent forms are essential documents, they aren’t the formal submission used to grant permission to initiate the trial.

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