Drug Evaluation Committee 2016-35 Record of Deviations from the Clinical Trial Protocol
Related classification: Deviation
Date of first publication: October 2016
Question
Currently, our hospital has a record of deviations (deviations other than emergency risk avoidance; hereinafter referred to as "deviations"). We are currently discussing how to keep deviation records (deviations other than emergency risk avoidance, hereinafter referred to as "deviations") at our hospital. Currently, we record deviations as follows.
- Record the source material at the origin (e.g., in the test slip or test results if it is related to clinical testing, in the investigational drug management chart if it is related to investigational drug management, or in the medical record if it is attributed to the subject).
- Subsequently, it is also documented in the status report and the termination report.
(1) Whether or not the source document should be recorded in the source document
If we record deviations at the source, as is the current method, they are recorded in different places, and it is difficult to see at a glance which deviations occurred during the trial. I am not sure what to think. Please let us know your opinion.
(2) Whether or not the person recording the source documents should be the person recording the source documents
Under GCP, the investigator is either a principal investigator or a sub-investigator.
- The corresponding CRC writes the information, and the investigator or subinvestigator signs and dates the document as confirmation.
- If it is related to investigational drug administration, the investigational drug manager records it.
- If it is related to investigational drug administration, it should be written by the investigational drug administrator and signed and dated by the investigator.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 46 Guidance 2 states that "The investigator or sub-investigator must keep a record of all deviations from the study protocol, regardless of the reason. (1) The record of deviations must be kept in the following manner
(1) There are no rules regarding the format of the record of deviations. Even if the record is in different places, if all deviations and their reasons can be confirmed from the source documents, there is no need to make a new record. However, if the details of deviations cannot be read from the source documents, a new record must be created after discussing the matter with the investigator.
(2) In principle, source documents should be prepared by the person who performed the relevant work, so it is appropriate that the record of deviations should also be prepared by the person who performed the work that caused the deviation. For records prepared by an appropriate person, the investigator's signature and date of confirmation are not required. However, it is important that such deviations are promptly reported to the investigator. If the investigator created the deviation record as a clerical support to the investigator or sub-investigator, an acknowledgement signature and date by the investigator or other relevant person are required.