SOCRA CCRP Practice Exam

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What does ICH GCP 5.1.1 dictate regarding SOPs?

  1. All staff must be trained annually

  2. Investigators are responsible for creating SOPs

  3. Sponsors are responsible for implementing and maintaining QA/QC systems with written SOPs

  4. Regulatory authorities must approve all SOPs

The correct answer is: Sponsors are responsible for implementing and maintaining QA/QC systems with written SOPs

ICH GCP 5.1.1 states that sponsors are responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs). This means that sponsors are responsible for creating and maintaining SOPs, not just investigators. Additionally, SOPs should be regularly reviewed and updated as necessary. Option A is incorrect because it applies only to staff training, not SOPs. Option D is incorrect because regulatory authorities do not need to approve SOPs, but they may review them during an inspection.

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