From the Guidelines
The correct answer is A. TRUE. According to Good Clinical Practice (GCP) guidelines, every aspect of a research study must be thoroughly documented to ensure data integrity and usefulness, as supported by the American Society of Clinical Oncology statement on minimum standards and exemplary attributes of clinical trial sites 1. This comprehensive documentation requirement is fundamental to GCP compliance and serves multiple critical purposes, including:
- Creating an audit trail that allows for verification of study procedures
- Protecting research participants
- Ensuring scientific validity
- Facilitating regulatory oversight Without complete documentation, data collected during research may be considered unreliable or unusable for regulatory submissions. The principle of "what is not documented is considered not done" is central to GCP, emphasizing that documentation is not merely administrative but essential to the scientific and ethical validity of research, as implied by the importance of meeting minimum criteria for quality clinical trials 1. Proper documentation includes everything from protocol development and ethics committee approvals to informed consent processes, adverse event reporting, and data collection methods.
From the Research
GCP Certification
- The statement "every aspect of a research study must be documented in compliance with GCP guidelines in order to obtain useful data" is related to Good Clinical Practice (GCP) principles.
- GCP guidelines emphasize the importance of accurate and complete documentation of all aspects of a research study to ensure the quality and integrity of the data collected.
- According to GCP principles, documentation is essential for verifying the conduct of the study, the data collected, and the results obtained.
- The provided studies do not directly address the question of GCP certification, but they demonstrate the importance of proper documentation and adherence to guidelines in research studies 2, 3, 4, 5, 6.
- Based on the general principles of GCP, it can be inferred that proper documentation is crucial for obtaining useful data in research studies.
Answer to the Question
- The correct answer is: A. TRUE
- This answer is based on the general principles of GCP, which emphasize the importance of documentation and adherence to guidelines in research studies.
- The provided studies do not directly address the question, but they support the importance of proper documentation and adherence to guidelines in research studies 2, 3, 4, 5, 6.