Drug Evaluation Committee 2018-04 Re-performing Screening Inspections
Related classification: Obtaining consent
Date of first publication: June 2018
Question
Please explain what to do when a test prescribed for the screening phase does not meet the selection criteria for the usual prescribed tests and the test may be rerun, but the explanation document to the subject does not clearly state that the test may be rerun.
In the case that the subject should have originally been eligible for the test, but the test did not meet the criteria on the day of the retest due to a highly variable test, or the test method was unique to the clinical trial and the data was not properly obtained, making it difficult to properly evaluate the test, and a new retest is performed, etc., please explain what to do if there is a high likelihood that the subject will originally be retested and the test will be performed again. If there is a high possibility of re-testing and the protocol clearly states that re-testing will be conducted, but there is no mention of re-testing in the explanatory document, would it be a problem to re-test?
Since we have not obtained consent from the subject for the retest because it is not mentioned in the explanatory document, our plan is to explain the retest to the subject in advance and obtain verbal consent, and then enter a note to that effect in the medical record before retesting. Is this correct?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The explanatory document should describe the "method of the clinical trial" and "anticipated clinical benefits and risks or inconveniences" (GCP Article 51, Paragraph 1, Guidance 1).
In the case of your question, it is assumed from the beginning that there is a high possibility that retests will be performed for the tests stipulated in the screening phase, and the study protocol also clearly states that retests will be performed. We recommend that you discuss the revision of the explanatory document with the investigator and sponsor.
If there is no mention of retesting in the explanatory document and retesting is to be conducted, this is a special case, and we believe it is necessary to discuss and decide how to obtain and record the subject's consent with the sponsor.