A Manual to Facilitate Clinical Data Collection from the Doctors in Other Hospitals Whom Subjects Consult for Serious Adverse Events during Clinical Trials

Abstract

It is mandatory to report any serious adverse event (SAE) that occurs during a clinical trial. When subjects consult doctors in other hospitals for SAE, clinical information must be shared not only for the patient’s care but also for SAE reporting and to adhere to the treatment protocol. However, the procedure to obtain clinical information from other hospitals has not been standardized. In this study, we compiled a manual taking into consideration the protection of the patient’s privacy in reference to the privacy protection guidelines and the GCP regulations. The treatment of SAE itself is within the general practice and out side of the treatment protocol. Therefore, an informed consent for the sharing of clinical information is not necessarily required. On the other hand, the reporting of SAE must be performed under the protocol and the GCP regulations. Therefore, an informed consent is considered necessary according to the Clinical Research Ethics Guideline. We consulted a jurist and a government authority in terms of the necessity of informed consent. They both commented that the informed consent is basically necessary but the exemption rules can be applied in the cases of conduct according to the law and the public health. Considering these comments, we compiled a manual that includes the acquisition of the informed consent for sharing clinical information between doctors at the time of participation and to inform the patient of the exchange of clinical information at the occurrence of SAE. This manual and the templates for the letters to doctors in other hospitals have been made public on our web site.