Drug Evaluation Committee Declaration of Data Integrity - Our Declaration" to ensure the reliability of clinical trials and clinical studies
Clinical Evaluation Subcommittee
To ensure the reliability of clinical trials and clinical studies of pharmaceuticals and other products, companies and industry organizations have been making various efforts, such as reviewing operational procedures and providing education and training.
In order to ensure the reliability of clinical trials, it is important to maintain data integrity (completeness, consistency, and accuracy of data), and even a partial loss of data integrity can lead to a betrayal of the precious wishes of patients who cooperate in clinical trials. In order to maintain data integrity, we believe that it is important for all people involved in clinical trials and clinical studies to respect each other in their respective roles and work together.
Therefore, the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association, in collaboration with the Japan SMO Association and the Japan CRO Association, has formulated the "Data Integrity Declaration - Our Declaration" in order to reaffirm the importance of ensuring reliability among all parties involved in clinical trials and clinical studies.
We ask that all parties involved in clinical trials and trials reaffirm the importance of data integrity, and that they remember this Declaration in their daily activities.
Data Integrity Declaration - Our Declaration
- We understand and respect the position and role of all people involved in clinical trials, including patients who cooperate with us, and we will work together to ensure data integrity (completeness, consistency, and accuracy of data).
- We will never forget the precious intentions of patients who cooperate with us, and we will never, under any circumstances, act in a manner that would betray those intentions.
- We will link all the data we receive from cooperating patients while maintaining the "accuracy" of the data for the benefit of future patients.
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