Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 69

A good way to begin this portion of the discussion on communication is to recall ICH E6(R2) Principle 2.10 which reads: All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.

Citing this principle makes sense here because recording, storing, and reporting on the large number of communications which will take place as part of the clinical trial scheme calls for training, a commitment to the record keeping fundamentals embodied in ALCOA [3] and a willingness on the part of staff to take the time to create a record. ICH E6(R2) does not use the terminology ALCOA but at section 4.9.0 states that source data should be attributable, legible, contemporaneous, original, accurate, and complete.

Earlier we noted the ways in which communication will occur with the regulatory authority. Meetings will generally involve a relatively small number of people and there will be a person appointed to act as the executive secretary or notetaker. During the course of a trial however there may be numerous times when a member(s) of the trial team will interact with a member(s) of the regulatory authority on a topic specific to their role on the trial team. It will be essential that those communications are recorded and made part of the TMF as well as being shared with all parties who need to know. It should not be assumed that every sponsor will have an SOP describing the process of documenting communications via phone (or otherwise) with representatives of a regulatory authority. Such procedures will usually be accompanied by a blank form to be used for documenting the specific of the call, meeting, etc. In times past, such records were made in pen and ink on three part carbonless forms which accommodated distributing the record, archiving it, and maintaining a personal copy. The blank form provided the user with places to record the basic elements of a communication such as names, titles, times, contact numbers, and substance of the communication. E‐mail or a memo to the files would likely be used today but the parameters are the same. In order for the record, whether made in writing or electronically, to be in conformance with GCP, it must be legible, contemporaneous, original, complete, accurate, and clear as to who the author is. There is nothing more problematic than having an inspector from a regulatory authority, who is reviewing records of adverse experiences, find one with the word YIKES written across it in red ink! Try explaining that entry. The record must also be permanent so that any additions, changes or versions are clearly identified. In the case of meeting with or communicating with a regulatory authority it is sometimes appropriate to share the record of meeting with them. Doing so does not mean they consider it the only record or the “official” one but at least they will know you created a record and its content. This type of record keeping guidance and explanation will be mentioned in several places in the text and it is appropriate to do so because it is a fundamental requirement of applying GCP principles.