What types of records must be kept by the sponsor as stipulated in ICH E6?

What types of records must be kept by the sponsor as stipulated in ICH E6?

• A. Only financial records of the trial.
• B. Records related to study design, protocols, and participant safety.
• C. Communications with regulatory authorities.
• D. Only completed data collection forms.

Answer: (B)

The information mandated by ICH E6 highlights the critical importance of maintaining comprehensive records that encompass various aspects of clinical trials, specifically focusing on study design, protocols, and participant safety. This approach ensures that all relevant information related to the conduct of the trial is available for review and evaluation, which is essential for compliance with regulatory standards and for verifying the integrity and quality of the trial data. Records related to study design include protocols that outline the methodology and objectives of the study, detailing how the trial will be conducted. This foundational documentation is crucial for guiding the trial and ensuring that it operates within its planned framework. Additionally, records that ensure participant safety are vital as they track any adverse events, informed consent documents, and safety monitoring protocols, thereby prioritizing the well-being of participants throughout the trial. Other options focus on narrower aspects of record-keeping that do not capture the full scope of what is required by ICH E6. Financial records, communications with regulatory authorities, or only completed data collection forms do not collectively encompass the comprehensive requirement for maintaining study-related documentation. ICH E6 emphasizes a holistic approach to record-keeping, aligned with good clinical practice, reinforcing the notion that meticulous documentation supports the ethical and scientific integrity of clinical research.

The information mandated by ICH E6 highlights the critical importance of maintaining comprehensive records that encompass various aspects of clinical trials, specifically focusing on study design, protocols, and participant safety. This approach ensures that all relevant information related to the conduct of the trial is available for review and evaluation, which is essential for compliance with regulatory standards and for verifying the integrity and quality of the trial data.

Records related to study design include protocols that outline the methodology and objectives of the study, detailing how the trial will be conducted. This foundational documentation is crucial for guiding the trial and ensuring that it operates within its planned framework. Additionally, records that ensure participant safety are vital as they track any adverse events, informed consent documents, and safety monitoring protocols, thereby prioritizing the well-being of participants throughout the trial.

Other options focus on narrower aspects of record-keeping that do not capture the full scope of what is required by ICH E6. Financial records, communications with regulatory authorities, or only completed data collection forms do not collectively encompass the comprehensive requirement for maintaining study-related documentation. ICH E6 emphasizes a holistic approach to record-keeping, aligned with good clinical practice, reinforcing the notion that meticulous documentation supports the ethical and scientific integrity of clinical research.