Drug Evaluation Committee 2014-28 Time of Designation and Contracting of Temporary CRC as a Clinical Research Collaborator (Part 2)
Related classification: clinical trial contracting procedures
First published: November 2014
Revised publication date: March 2021
Question
This time, as our hospital only accepts temporary CRC, we signed the contract for each clinical trial after the approval of the clinical trial contract by the investigational review board ("IRB"), and it was pointed out to us that the contract of services agreement (hospital-SMO) should originally be signed before the initial IRB approval.
When I asked why, he explained that generally, when SMO support enters a hospital for the first time, the basic contract is signed first, followed by the IRB, and then the contract for each individual clinical trial.
In question No. 2005-01, it is stated that the items to be discussed at the IRB regarding dispatch (appropriateness of accepting a dispatched CRC, eligibility of the SMO dispatching the CRC, eligibility of the dispatched CRC, etc.) are not mandatory items required by GCP, but our hospital also discusses these issues, including CRC acceptance, at the IRB, However, the IRB deliberates on these issues, including the acceptance of CRC at our hospital.
Since the IRB is also deliberating on SMO acceptance, we feel that contracting should be done after IRB approval. The hospital's contracting officer is also of the opinion that it is not appropriate to contract for a clinical trial that has not been approved by the IRB, and we are having trouble with the timing of the contract for the outsourced temporary CRC.
There was a clinical trial in which the contract of entrustment of dispatched CRC was a condition for conducting the clinical trial, so please tell me why the contract is required before IRB approval.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regardless of the type of contract, such as the existence of a basic contract between the SMO and the implementing institution, as long as the contract is concluded before the dispatched CRC starts the relevant work, the timing of the conclusion of the contract can be either before or after IRB approval.
Therefore, if your hospital determines that IRB deliberation is necessary to accept a CRC or SMO, there is no problem with concluding a contract after IRB approval.
In addition, Article 39-2 Guidance 1 of the GCP states that "the site shall ensure that the contractor meets the requirements to be able to perform the entrusted clinical trial work, and shall take measures to ensure the reliability of the clinical trial work performed and the data generated. However, GCP does not require the IRB to deliberate on SMO services such as CRC dispatch, etc. Therefore, it is recommended that the IRB fully consider whether the deliberation on SMO acceptance is necessary from the viewpoint of subject protection and the scientific nature of the clinical trial.
Reason for revision of opinion
The guidance citation has been added in accordance with the revision of the GCP guidance (July 5, 2028, Pharmaceutical Affairs Bureau of Japan, No. 0705, No. 3).