Drug Evaluation Committee 2010-45 Correction method for erroneous information in the consent form by subjects
Related classification: Obtaining consent
Date of first publication: February 2011
Question
In a clinical trial involving infants and young children, we corrected an error in the subject's (guardian's) entry in the consent form with a double-line correction, and the sponsor requested us to obtain the subject's (guardian's) signature or name and seal.
The reason was that consent is the most important item in GCP, and the sponsor wanted to make it clear that the error had been corrected. However, we believe that this is an excessive response, since the consent is not invalid without the signature or name and seal for the error, and there is no legal basis for it.
When we asked other sponsors for their opinions, some said, "It is desirable to obtain a signature or a seal if possible," and others said, "If the circumstances of the error are known, a signature or a seal is not necessary. We would appreciate it if you could tell us what the JPMA's view is on this matter.
JPMA's Opinion
GCP does not specify how to correct errors in the consent document.
The consent document is an important document that certifies that the subject voluntarily participated in the clinical trial. Although we do not know from your question what kind of mistake was made, if the correction is made in such a way that the credibility of the subject's own (or a surrogate's) consent is questioned (i.e., if it cannot be made clear to a third party that the correction was not falsification), then we would suggest that you correct the mistake in the consent document. In this case, the signature (or name and seal) of the person who made the amendment to the consent document is considered necessary.