Drug Evaluation Committee 2023-33 Preparation of Monitoring Reports
Related Category: Other
Initial Publication Date: March 2024
Question
Regarding the preparation of monitoring reports, Article 22, Paragraph 2 of the GCP states: “When conducting monitoring, if a monitor performs the monitoring on-site at an Investigator Site or communicates with the Site, the monitor must submit a monitoring report to the sponsor on each occasion, containing the following items.(Omitted below).”On the other hand, when examining how sponsors of various clinical trials maintain their records, it varies from sponsor to sponsor:
・For standardized forms, since the document itself is stored in the Trial Master File (TMF), it serves as a record of the exchange, and it is not necessary to prepare a separate monitoring report.
・If there are emails or cover letters accompanying the submission of documents, storing them in the TMF serves as a record of the exchange, eliminating the need to prepare a separate monitoring report
・ If important communications with the site or opinions are received via email, storing those emails serves as a record of the background and discussions, eliminating the need to prepare a separate monitoring report
There are many examples of clinical trials being conducted under such rules.
Although GCP stipulates that a monitoring report must be prepared each time contact is made with the Investigator Site, the specific scope and operational details may be determined by the sponsor in the monitoring plan or other procedural documents, andit is not necessarily required to prepare a monitoring report for all monitoring activities as specified in GCP Article 21, Paragraph 1, Item 9 (provided that the background and circumstances can be inferred from other sources, which may serve as a substitute). Is this understanding correct?Furthermore, in such cases, if there are any points or considerations the sponsor should keep in mind when establishing rules and operational procedures, we would appreciate your guidance.
Recently, as part of the overall trend in clinical trials, risk-based monitoring and prioritization have become necessary; therefore, we would like to clarify our approach when reviewing the clinical trial protocol.
JPMA Opinion
Article 22, Paragraph 2 of GCP states: “When conducting monitoring, if a monitor performs the monitoring on-site at an Investigator Site or communicates with the Site, the monitor must submit a monitoring report to the sponsor on each occasion, detailing the matters listed below.” Therefore, if this applies, a monitoring report must be prepared.On the other hand, “monitoring” is defined in Article 2, Paragraph 22 of the GCP as follows:
“In this Ministerial Ordinance, ‘monitoring’ means, in order to ensure that a clinical trial or a post-marketing clinical trial is being conducted properly,the sponsor of a clinical trial or post-marketing clinical trial conducts an investigation of the Investigator Site regarding the progress of the clinical trial or post-marketing clinical trial and whether it is being conducted in accordance with this Ministerial Ordinance and the clinical trial protocol or post-marketing clinical trial protocol.”
Therefore, when determining whether it is necessary to prepare a monitoring report or whether other methods—such as retaining standardized forms, cover letters, and emails—are sufficient, the decision must be made by reviewing the definition of “monitoring” and considering whether each method is appropriate for maintaining records and meets regulatory requirements.Furthermore, when establishing rules and operational procedures, we believe it is necessary to clearly stipulate in standard operating procedures (SOPs), monitoring plans, and other reference documents whether each method is suitable as a record.