What should be contained, according to the ICH, the medical history of a patient who participates in a clinical trial.
What should be contained, according to the ICH, the medical history of a patient who participates in a clinical trial. Spain, March 2012.- medical history of a patient in a clinical trial should be more complete than a follow-up of a patient in routine clinical practice. The visit in which a patient is included in a clinical trial must include at least the following information which for example would be; included in the clinical trial patient: title ” with code protocol code. The patient is informed on the study, gives its consent _ / _ / _ day and delivered copy of the same. He is assigned the following number of patient: — —- and was randomized to the Group — — — — (control/treatment), with the following number of randomización — — — — —-. There is a first visit, called the visit of selection in which the patient signed informed consent in the majority of clinical trials. It is included on the basis of the information available until his signing, when it meets most of the verifiable selection criteria at that time. Once the patient has given consent, should be done all the tests described in the Protocol to verify that the patient meets all the criteria for inclusion and none of of exclusion is often a window of 15 to 30 days in which is expected...
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