What are “Essential Documents” according to ICH E6?

What are “Essential Documents” according to ICH E6?

• A. Documents that only the sponsor must retain
• B. Documents required solely for market approval
• C. Documents allowing evaluation of study conduct and data quality
• D. Documents concerning financial arrangements with investigators

Answer: (C)

Essential documents, as defined by ICH E6, serve a critical role in the clinical trial process. They provide the necessary information that enables the assessment of both the conduct of a clinical study and the quality of the data generated. Essential documents encompass a range of materials, including protocols, informed consent forms, case report forms, and records of the investigators' qualifications. Together, these documents ensure that trials are conducted in compliance with applicable regulatory requirements and good clinical practice (GCP) standards. By focusing on their pivotal role in evaluating study conduct and data integrity, these documents help maintain the validity and reliability of the trial outcomes. Their proper management and retention are vital for regulatory inspection and for establishing the authenticity of the clinical findings.

Essential documents, as defined by ICH E6, serve a critical role in the clinical trial process. They provide the necessary information that enables the assessment of both the conduct of a clinical study and the quality of the data generated. Essential documents encompass a range of materials, including protocols, informed consent forms, case report forms, and records of the investigators' qualifications. Together, these documents ensure that trials are conducted in compliance with applicable regulatory requirements and good clinical practice (GCP) standards.

By focusing on their pivotal role in evaluating study conduct and data integrity, these documents help maintain the validity and reliability of the trial outcomes. Their proper management and retention are vital for regulatory inspection and for establishing the authenticity of the clinical findings.