Knowledge Base

How to respect the privacy of subjects in clinical trials?

9 January 2024
2 min read

In order to protect the privacy of the subjects, the names of the subjects participating in the clinical trial should not be filled in the trial related documents, especially the documents to be submitted to the sponsor, and only the initials should be used. When the subject's name or other identity information (such as the hospital) is recorded in the subject enrollment form and the informed consent form, these documents should be kept by the investigator. Once enrolled in the trial, the subject will be assigned a unique trial number, which will be filled in all relevant trial documents as the subject's code, and this number also determines the trial treatment allocation received by the subject. The researcher has the responsibility to protect the subject's privacy. Therefore, the sponsor will only receive the trial documents with the subject number. The declaration of Helsinki clarifies the rights and interests of subjects participating in clinical trials. The GCP was formulated according to the declaration of Helsinki, and the national law also stated that the ethics committee must approve the implementation of the trial, and informed consent should be obtained before the subjects were enrolled. Before enrolling the subjects, the possible benefits and risks of the subjects should be considered. After being unconditionally informed of the details of the trial and study medication, the subjects should voluntarily make the choice of whether to participate in the trial. No matter whether they participate or not, their decision should not affect the researcher's treatment in the future. Moreover, during the trial, the subject can unconditionally withdraw from the trial at any time without providing any reason.

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