Drug Evaluation Committee 2023-33 Preparation of Monitoring Report
Related classification: Other
Date of first publication: Mar 2024
Question
Regarding the preparation of monitoring reports, Article 22, Paragraph 2 of the GCP states, "Monitors shall submit to the sponsor a monitoring report describing the following items each time they conduct monitoring on-site at the site or communicate with the site. （The following items are omitted hereafter.On the other hand, when we look at how the sponsors of various clinical trials keep records, it differs from sponsor to sponsor,
In the Uniform Form, the documents themselves are stored in the Trial Master File, so they become the record of transfers, and there is no need to prepare a separate monitoring report .
If there is an e-mail or a letter of transmittal when materials are sent, it is stored in the TMF and becomes a record of transmittal, making it unnecessary to prepare a separate monitoring report .
If important correspondence or comments are received via e-mail, the e-mails can be stored in the TMF as a record of the discussions and the process, so there is no need to prepare a separate monitoring report.
There are many cases where clinical trials are conducted under such rules.
However, the detailed scope and operation of these rules can be agreed upon by each sponsor in the monitoring plan and other procedure manuals, and not necessarily all monitoring activities as stipulated in Article 21, Paragraph 1, Item 9 of the GCP. Is it correct to understand that a monitoring report is not necessarily required for all monitoring activities as stipulated in Article 21, Paragraph 1, Item 9 of the GCP (if the history, etc. can be read separately, it can be substituted)? Also, in that case, we would like to know if there are any points to keep in mind when deciding the rules and operation on the sponsor's side.
Recently, monitoring based on risk and making it more balanced have become necessary for clinical trials as a whole, and we would like to organize our thinking when considering the clinical trial plan.
Pharmaceutical Association of Japan (PAK) Opinion
Article 22, Paragraph 2 of the GCP states that "Monitors shall submit to the sponsor a monitoring report describing the following items each time they conduct monitoring at the site or communicate with the site. Therefore, a monitoring report must be prepared in cases where this applies.On the other hand, "monitoring" is defined in Article 22 of GCP Article 2 as follows
The term "monitoring" as used in this Ministerial Ordinance means the monitoring of the progress of a clinical trial or post-marketing clinical trial and whether the clinical trial or post-marketing clinical trial is being conducted in accordance with this Ministerial Ordinance and the clinical trial protocol or post-marketing clinical trial plan, in order to ensure that the clinical trial or post-marketing clinical trial is properly conducted. (2) "Monitoring report" means an investigation conducted by the person who requested the clinical trial or the post-marketing clinical trial to the medical institution regarding the progress of the clinical trial or the post-marketing clinical trial and whether the clinical trial or the post-marketing clinical trial is being conducted in accordance with this Ministerial Ordinance and the clinical trial plan or post-marketing clinical trial protocol.
Therefore, the judgment and criteria as to whether a monitoring report needs to be prepared or whether other methods, such as keeping a uniform form, letter of transmittal and e-mail, are acceptable, should be determined by checking the definition of monitoring and considering whether each method is suitable as a record-keeping method and whether it meets regulatory requirements. It is necessary to determine whether each method is appropriate for record keeping and whether it meets regulatory requirements. In addition, when determining the rules and operations, it is necessary to clearly stipulate the rules and operations in standard documents such as standard operating procedures and monitoring plans to ensure that each method is suitable for record keeping.