Drug Evaluation Committee 2007-32 Relationship between Clinical Trial Duration, Contract Signing Date and Drug Delivery Date
Related classification: clinical trial contracting procedures
Date of first publication: August 2008
Question
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1.Does the clinical trial period stipulated in the protocol refer to the GCP period related to the handling of subjects? Or can we leave it to the sponsor's opinion? If there is a definition for the duration of a clinical trial, we would appreciate it if you could explain it to us.
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2.If the situation is as follows, when can the original contract (clinical trial agreement) be signed and the investigational new drug be delivered?
- (1)The IRB approved the initial discussion on January 31, 2008.
- (2)(2) The Director of the site where the clinical trial is being conducted issued a notice of approval on February 1, 2008.
- (3)(3) The study period in the study protocol agreed with the investigator is from March 1, 2008 to March 31, 2009.
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Normally, we believe that we can enter into a contract anytime after IRB approval and notification of the Director's decision to issue an order.
We believe that the delivery of the investigational new drug can also be made after the conclusion of the contract, but we are not sure for the reasons stated above.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding your question 1, please refer to the opinion ( question no. 2007-16 ) on "Recall of case report forms and investigational new drugs after the contract period" published in the "Questions and Opinions on Clinical Trials 119" on the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ).
Regarding your question 2, "Conclusion of a clinical trial agreement," an agreement can be concluded after the date of notification of the decision to issue instructions by the head of the investigational site. There is no problem even if it is before the period of the clinical trial as stipulated in the clinical trial protocol. Furthermore, as to your question, the investigator's agreed period of the clinical trial is "March 1, 2008 to March 31, 2009," so the "period of the clinical trial" that should be stated in the clinical trial agreement is within that agreed period. Even if the date of the agreement is before March 1, 2008, the start date of the clinical trial period to be stated in the agreement will be after March 1.
Regarding the delivery of investigational new drug, Article 11 of the GCP stipulates that "a person who requests a clinical trial must not deliver the investigational new drug to the site before the conclusion of the contract for the clinical trial. Therefore, the investigational new drug can be delivered after the date of conclusion of the contract.
Thus, if the date of conclusion of the clinical trial contract is different from the date of commencement of the clinical trial period as stated in the clinical trial contract, the investigator must be very careful not to explain the clinical trial to patients or perform other clinical trial activities prior to the commencement of the clinical trial period. In order to prevent such mistakes, it is recommended that the date of contract conclusion and the start date of the clinical trial period be close to each other.