Drug Evaluation Committee Date of start of use of the revised version of the 2017-73 Explanatory Document
Related classification: Obtaining consent
Date of first publication: February 2018
Question
What is the timing of re-consent?
The explanatory document for subjects has now been revised and approved by the Clinical Trial Review Committee. At our hospital, a written notice of the results of the clinical trial review and a written notice of the decision to give instructions to the head of the medical institution (hereafter, "the results notice") is issued on the following day and sent to the sponsor (or CRO) on the day after that. In this case, the subject came to our hospital the day after the Clinical Trial Review Committee meeting, and since we had not yet received the revised explanatory document printed by the CRO, we printed the revised version ourselves, explained it to the subject, obtained his/her consent, and obtained his/her signature.
However, we were informed by the CRO that we should not re-consent from the subjects until the CRO received and confirmed the result notification. I had not received that explanation beforehand. I was surprised because I usually take re-consent without delay when a subject comes to the hospital after approval by the Clinical Trial Review Committee. I was told that even if the results were notified the next day, oral consent was the only way to obtain consent, but that is what the CRO's regulations stipulate. Two such CROs followed.
Verbal consent was already obtained when we were notified of the revisions and is documented in the medical record. Nonetheless, do they take oral consent again at the time of the visit after the approval of the revisions? Does the decision of the Clinical Trial Review Committee's approval take effect only after the written notification of results is received by the CRO?
If the CRO changes during the course of the study, and the next CRO does not have such a rule, won't the next CRO be pointed out for not taking re-consent immediately this time?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If new important information is obtained that affects the subject's consent, the investigator must promptly revise the explanatory document and obtain approval from the Clinical Trial Review Committee. In addition, the investigator or sub-investigator must explain again using the revised explanatory document and obtain the subject's consent in writing (GCP Article 54, Paragraph 2/3, Guidance 1).
Thus, it is the investigator's responsibility to revise the explanatory document and obtain written consent again. Therefore, when the approval by the investigational review committee and the head of the institution is confirmed and the revised explanatory document becomes available, the investigator must promptly use the document to explain to the subject and obtain consent in writing. In this case, there is no need to wait for confirmation of the sponsor's result notification. However, it is important to discuss the details of the revised explanatory document with the sponsor in advance.