Which of the following is NOT a requirement for essential documents in ICH E6?

Which of the following is NOT a requirement for essential documents in ICH E6?

• A. Documentation of participant consent
• B. Store documents in a digital format only
• C. Records of the trial’s protocol amendments
• D. Access logs for source documents

Answer: (B)

The focus of this question is on identifying which option does not align with the requirements for essential documents as outlined in ICH E6. Essential documents are critical for demonstrating compliance with Good Clinical Practice (GCP) and for the integrity and quality of clinical trial data. The correct answer indicates that storing documents in a digital format only is not a requirement. ICH E6 recognizes both paper and electronic formats for documentation, allowing for flexibility based on the needs of the study and the infrastructure of the sponsoring organization or site. What is essential is that these documents be stored in a manner that ensures their integrity and availability, rather than mandating a specific storage format. On the other hand, the other options listed — documentation of participant consent, records of the trial’s protocol amendments, and access logs for source documents — are all critical components of essential documents. They play important roles in ensuring participant rights and safety, maintaining trial integrity, and facilitating regulatory compliance.

The focus of this question is on identifying which option does not align with the requirements for essential documents as outlined in ICH E6. Essential documents are critical for demonstrating compliance with Good Clinical Practice (GCP) and for the integrity and quality of clinical trial data.

The correct answer indicates that storing documents in a digital format only is not a requirement. ICH E6 recognizes both paper and electronic formats for documentation, allowing for flexibility based on the needs of the study and the infrastructure of the sponsoring organization or site. What is essential is that these documents be stored in a manner that ensures their integrity and availability, rather than mandating a specific storage format.

On the other hand, the other options listed — documentation of participant consent, records of the trial’s protocol amendments, and access logs for source documents — are all critical components of essential documents. They play important roles in ensuring participant rights and safety, maintaining trial integrity, and facilitating regulatory compliance.