Drug Evaluation Committee 2005-15 Provision of Clinical Trial Protocols in Electronic Media, Transmission of Clinical Laboratory Data, etc.
Related classification: Other
Date of first publication: Mar. 2007
Question
We are currently considering how to handle clinical trial operations when electronic clinical records are adopted.
We would appreciate your response as follows.
(1) Provision of protocols in electronic media
Is it possible to provide protocols in electronic media (Word or PDF format) for reference in the electronic medical record?
(2) Regarding the provision of SGML files
Will you continue to do so in the future?
(3) Regarding the support of filmless systems
Even at filmless facilities, are films ever specified for provision to the sponsor?
Currently, we have a mixture of various formats such as CD-R, MO, film, etc. Is there a direction to unify them into one format?
(4) About the handling of test data at contract laboratories for clinical laboratory measurement
We would like to be able to receive data electronically and treat it as source documents by importing it into the electronic medical record.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
(1) Provision of protocols in electronic media
As stated in Article 10, Paragraph 2 of the GCP, documents to be submitted to the head of the site are allowed to be submitted by electromagnetic means, and the investigational protocol can also be provided, but it is necessary to meet the requirements for the system, etc. as stated in the same paragraph and Paragraph 3.
(2) Regarding the provision of SGML files
Currently, only a very small number of implementing medical institutions are required to submit SGML. Considering the time and cost required to create SGML, it is not efficient, and we would like the current situation to be reconsidered, if possible.
(3) Regarding the support of filmless systems
Although we do not have a grasp of the current situation, we believe that there are cases where we currently ask for provision of the data on film, even if it has been made filmless, depending on the purpose of the request for provision and the environment in which the data will be referenced. The medium of provision may vary depending on the target disease and purpose of the clinical trial, but if the environment for computerization is sufficiently prepared in the future, we believe that it will be possible to respond to the request with a filmless system.
(4) About the handling of test data at contract laboratories for clinical laboratory measurement
It is still possible to provide clinical laboratory data electronically, but system validation will be required. In addition, we may ask about the electronic medical record system during monitoring and audits when the system is converted to electronic medical records, so we would appreciate your cooperation.