Drug Evaluation Committee 2013-27 Recording method at the time of oral consent and contents of the explanation document

GCP Article 54, Paragraph 1, Guidance 1 states, "When information is obtained that may influence the subject's or surrogate's decision to continue participating in the clinical trial, (omitted) in this case, the fact that the subject or surrogate has been informed of this information should be recorded in writing. Is it sufficient to record the information in the electronic medical record? For example, is it acceptable to state in the electronic medical record that the information was explained orally and that oral consent was obtained?

In terms of the contents to be described in the consent document, Article 51, Paragraph 1, Guidance 1 of the GCP states "(6) Availability of other treatment methods and significant anticipated benefits and risks associated with such treatment methods". If "other treatment options are available," how should the risks be described?

We believe that there is no problem if the electronic medical record includes the date and content of the explanation, as well as a statement that the patient's intention to continue participation in the clinical trial has been confirmed.

As stipulated in Article 51, Paragraph 1, Guidance 1 (6) of the GCP, the explanatory document must state "the existence of other treatment methods and the significant benefits and risks anticipated with respect to such treatment methods. For example, in the case of drug therapy, information on side effects, etc., as described in the drug's package insert, should be included.