Clinical trials and site File Management: how to decide when communication is relevant and when it is not.
I came across a clinical trials guidance document written by the GCP Records Managers Association to help researchers decide what communication is considered relevant (and therefore should be keep in the site file) and what communication is not. This document was intended to supplement ICH GCP section 8.3.1 entitled ‘relevant communications other than site visits’.
|RELEVANT COMMUNICATIONS OTHER THAN SITE VISITS– letters- meeting notes- notes of telephone calls
|To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting
The document first defines communication as a letter, email, telephone contact, fax or meeting minutes. It goes without saying that some ‘communication’ documents are GCP documents in their own rights such as an Ethics Approval letter which would not be filed in the ‘Correspondence’ section but the ‘Regulatory Approval’ section of the site file.
As a general rule all communication should be business-like, and contain no personal information. It should be professional, courteous, not “chatty” and only discuss study matters and only one study per email.
What is Relevant Communication?
1- Communications that document agreements or significant discussion regarding: trial administration, protocol violations, trial conduct and adverse event reporting.
2- When deciding whether an email message should be filed, the context as well as the content should be considered. Emails that should be filed may pertain to substantial discussions, information distributed to groups of people expected to take action or to comply with instructions or to raise their awareness of a critical situation and finally agreements to proceed.
3- Emails that might provide evidence of the reason for a particular course of action should also be kept and filed. This should include all emails discussing the decision making process not just the final decision. An example may be around including a patient in a study when the inclusion/exclusion criteria are not 100% clear.
4- Other areas where it would be important to keep a documentation trail are when there is no SOP or policy to support a decision or a process followed.
5- *IMPORTANT* To ensure legal admissibility, preserve provenance and integrity and to capture header metadata, email messages should be saved in their native format i.e. MS Outlook as a .msg file. This holds true for both the initial email and for each subsequent receipt and response. The reason for this is that when using “Reply” or “Forward” functions header information is embedded into the response as alterable text and may therefore be changed.
What is Non-Relevant Communication?
1- This may include communication related to a decision captured elsewhere in a formal document held in the site file i.e. minutes from a teleconference where a decision was made.
2- Ephemeral communication should not be kept. Ephemeral documents are defined as documents of trivial nature and therefore not business critical or only of short term value i.e. an email invitation to a meeting. These types of documents have little or no value as a record of compliance.
Location of Relevant Communications within the Site File
1- There are three ways communication could be filed in the site file:
- Communication is filed according to subject to which is relates i.e. if the emails are about an adverse event, then it would be filed under ‘Safety Reporting’.
- All communication is filed in one dedicated section often called ‘Correspondence’.
- Or a hybrid system where subject related communications are filed in their related category and all other communication is filed in the separate ‘Correspondence’ section.
2- When using systems two or three listed above, it is recommended that you subdivide the general communication section by ‘Internal Communication’, ‘Third Party Communication’ and where relevant ‘Sponsor Communication’.
3- Subdivision simply enhances the ease of retrieval and prevents the MHRA inspector from waiting :).
I hope this helps you to better understand what to keep, what not to keep and the importance of professionalism when communicating via emails about clinical trials. In summary one should be able to re-create the entire life of a trial with the site file and Case Report Forms. Let’s face it, we hope we never have to do it…but just in case Mr Poirot needs to investigate, we might as well be as kind to him as possible.
What special tricks or rules do you have for keeping complete and orderly records for your study?
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