Drug Evaluation Committee 2012-38 Establishment of a procedure manual for omitting signatures and seals for clinical trial procedures
Related classification: Clinical trial contract procedures
Date of first publication: December 2012
Question
Questions regarding the "JPMA Clinical Evaluation Subcommittee, Electronic Standard for Medical Information Expert Committee's Discussion Results and Basic Policies" dated May 22, 2012.
Regarding the basic policy "1. seal", a sponsor (a pharmaceutical company) has asked us to prepare the procedure manual, etc., as described in the attached sheet.
We have received an inquiry from a sponsor (pharmaceutical company) that they cannot make a contract unless the procedure manuals, etc., are in place. The hospital believes that verification of alteration by a method other than affixing a seal is possible by checking it against the original at the time of SDV. Is it mandatory to prepare a procedure manual, etc.?
JPMA's Opinion
The JPMA's basic policy on documentation mentioned in your question includes the following Explanation.
A document can be interpreted as an original if it is processed and stored in accordance with the prescribed procedures (which indicate the roles of the head of the site, investigator or other person responsible for preparation of the document, and the work flow of the investigator or other person supporting the work, such as the secretariat of the clinical trial). If necessary, it is possible to confirm whether or not there is any alteration by comparing multiple stored documents.
Also, as stated in Q&A 3-1 of the document, as a precondition for omitting signatures and seals on individual documents, it is necessary to show by a process or other means that the documents were properly prepared and that they have not been altered and that this can be verified even without signatures and seals. As an example of this process, the attached procedure is provided. It is important to specify "when," "who (whose responsibility)," and "what (which form)" should be prepared at your hospital, which is a prerequisite for omitting the seal. Therefore, we believe that it is necessary to show the process in some document such as a procedure manual.