Drug Evaluation Committee 2016-54 Time of commencement of subject recruitment operations
Related classification: subject recruitment
Date of first publication: February 2017
Question
Matters currently planned
At the start of a clinical trial, we plan to enter into a contract with a company that provides subject recruitment services (hereinafter referred to as "subject recruitment company") in order to promote the inclusion of cases and conduct subject recruitment. At that time, we are planning to conclude a comprehensive outsourcing agreement in advance between the medical institution, the SMO, and the subject recruitment company. Then, when the clinical trial is actually conducted, we plan to conclude a separate outsourcing agreement for each clinical trial.
The clinical trial review committee will review the recruitment of test subjects, and if the results are approved, we plan to actually use the subject recruitment company to recruit the test subjects.
Question
Which of the following would be appropriate for a subject recruitment company to actually recruit potential subjects for the study?
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(1)After concluding a clinical trial agreement
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(2)After the date of approval by the Clinical Trial Review Committee and notification by the Chairperson of the implementing medical institution on the Notification of Clinical Trial Review Results
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(3)After the conclusion of the contract of commissioning between the site ⇔ SMO ⇔ subject recruitment company for each clinical trial.
- *(Contract of each trial with the subject recruitment company is concluded after the clinical trial protocol is agreed upon (prior to the review by the Clinical Trial Review Committee).
- *Actual subject enrollment is done after the clinical trial agreement is signed.
There are cases where it takes some time after the review by the Clinical Trial Review Committee to conclude a clinical trial agreement, and we would like to be able to recruit potential test subjects as soon as possible, but there are opinions that it would be appropriate to start operations related to the clinical trial after the conclusion of the clinical trial agreement. We would very much like to hear the Japan Pharmaceutical Manufacturers Association's opinion on this matter.
JPMA's Opinion
The procedure for recruiting subjects is a matter for review by the Clinical Trial Review Committee (GCP Article 32, Paragraph 1, Item 2). Therefore, we believe that the recruitment of test subjects should start after the date of the approval by the Clinical Trial Review Committee and the notification of the decision of the instructions by the Chairperson of the implementing medical institution.
Whether or not this work should start after the conclusion of the clinical trial agreement with the sponsor is to be determined by the implementing medical institution in light of the actual recruitment work.