59- Data Integrity, Informed Consent, and Recordkeeping in cGCP (S22E5)
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59- Data Integrity, Informed Consent, and Recordkeeping in cGCP (S22E5)
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このコンテンツについて
This episode explores the fundamental principles of data integrity and its importance in ensuring trial trustworthiness. It delves into the critical role of informed consent, which is the ethics and heart of clinical research, emphasizing the need for willingly and knowingly involved people in these trials. Finally, it explores the best practices in recordkeeping for clinical trials.
Finally, the use of key terms like audit trails and source data verification, is discussed, and the practical processes that support reliable, ethical, and compliant clinical research operations. This episode also explores the regulations and how they impact what is happening on the ground. Also considered is the role of regulatory agencies and how they are a part of the overall process.