Drug Evaluation Committee 2011-40 Necessity of reconfirmation after consent is obtained
Related classification: Obtaining consent
Date of first publication: Apr. 2012
Question
We have received the following requests from several sponsors (some sponsors have not requested the following responses).
- If the interval between obtaining consent and the start of study drug administration exceeds 28 days, the consent should be reconfirmed and recorded.
- If the interval between obtaining consent and Visit 1 (start of observation period) exceeds 28 days, reconfirm consent and keep a record.
- If the interval between obtaining consent and Visit 1 (start of observation period) exceeds 1 month, re-consent in writing.
In a previous GCP on-site inspection by the authorities, the investigator asked the following question: "There is an interval between the acquisition of consent and the start of the clinical trial. (The following questions were asked by each sponsor.) The following questions were clarified by each sponsor. Since we could not obtain a clear answer to the following question from each sponsor, we would be grateful for your opinion.
- Why limit the recording of reconfirmation of consent to before the start of the trial (why not request a record of reconfirmation of continued consent after the start of the trial)?
- Why doesn't the authority's GCP field investigator mention reconfirmation of continued consent after the start of the clinical trial?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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The explanatory document to the subject will state that the subject may withdraw from the clinical trial at any time, and consent will be obtained with the subject's understanding. Since this document is delivered to the subject, it is assumed that the subject understands that he/she can withdraw from the clinical trial at any time. Therefore, it is not necessary to confirm the subject's intention to continue participation in the clinical trial unless information that may affect the subject's intention to continue is obtained.
In addition, even if there is a gap between the acquisition of written consent and the actual start of the clinical trial, it is generally not necessary to obtain written consent again simply because there is a gap.
However, if the period between obtaining consent and participating in a clinical trial is very long and there is a possibility that the patient's intention to participate in the clinical trial has changed, reconfirmation of the patient's intention to participate is not necessarily required. The sponsor and investigator should discuss and decide whether reconfirmation is necessary or not and how to record the reconfirmation.
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We do not know the intention of the GCP inspector of the authorities, so we will refrain from answering this question.