SOCRA CCRP Practice Exam

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Which of the following is a guideline provided by ICH GCP for maintaining essential study documents?

Discard unwanted documents periodically
Maintain documents as required by regulations
Limit document access to principal investigators only
Use digital formats only to avoid paper waste

The correct answer is: Maintain documents as required by regulations

ICH GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice) is an international guideline for the conduct of clinical trials. It is important to maintain essential study documents in adherence to this guideline for the accuracy and integrity of the clinical trial. Option A is incorrect because discarding unwanted documents could lead to important information being lost. Option C is incorrect as limiting document access to only the principal investigators could hinder the oversight and review of the trial. Option D is incorrect because the use of digital formats alone is not recommended as it may pose potential risks to the integrity and security of the documents. Therefore, Option B is the correct answer as it aligns with the guideline to maintain necessary documents in accordance with regulations in order to ensure the reliability of the trial.