R.E.S.P.E.C.T. for the Site Master File for Clinical Research

Posted on by Kelly Gleason in Research

Our poor site master file for clinical research often gets neglected, we plan to spend Thursday afternoon filing and sorting but despite our best intentions, an SAE comes up, there are queries to be answered or more information is needed to complete a protocol amendment. We also often think that we are doing right by the patient focusing our attention on what is important to the patient and they have never even heard of a site file!

Site Master Files in the spotlight

Site Master Files in the spotlight

However, when the MHRA come to visit or you are chosen as a site for audit, this is the exact document that will give the overall impression of how well you are running your study and looking after participants. In other words, your site file is a direct reflection of your work standard…and that suddenly puts that poor neglected site file in the spotlight.

So here are a few common findings from MHRA inspections and external audits to help you keep your site file looking its best every day of the week:

1) Index your sites files correctly. There is no one right way of doing this, but it is important that you have a system and that you stick to it. Often a table of contents and dividers are provided, as with many industry sponsored studies, however, if you need to make your own sections and dividers here is a guide to help you get started:

Section 1: Contacts
Section 2: Protocol
Section 3: PIS, Consent Forms, GP letters
Section 4: Randomisation
Section 5: Pharmacovigilance
Section 7: CRFs, Monitoring and Audit
Section 8: Pathology and Histopathology
Section 9: Trial Initiation, Sponsorship, CVs, Agreements, Staff training
Section 10: Ethics, MHRA, R&D
Section 11: Correspondence

2) Version control is another common problem when someone unfamiliar with the study tries to put together the history of the study. It is good to have a ‘History Sheet’ in your protocol sections which simply lists each version of the protocol and the date the new version was approved.

Protocol History Sheet

If you file you protocols with the most current version on top and stamp all superseded versions with a ‘Superseded’ stamp, this will help anyone trying to put together the full picture of the study.


3) Another common finding is incomplete delegation logs with missing CVs and GCP certificates (and yes I can feel your frustration on this one!). It is not pleasant to spend your time chasing signatures, signed CVs and being the GCP training police…so is there a system that can be adopted in your area to help with this? For example, could these be kept in a separate file for your department and one person be made responsible for making sure all CVs and GCP certificates are current and up to date? Could this information be uploaded in a database that will flag when a researcher needs to update their CV or GCP training? If this can be delegated and centralised, a simple file note in every site file pointing to where CVs and GCP certificates are kept, how they are collected and kept current could help ease the burden of keeping on top of delegation logs, CVs and GCP certificates.

4) Enrolment and recruitment logs are another area where inspectors and auditors struggle. Keeping good records of enrolment and recruitment alongside your consent forms is important for many reasons. Patient Information Sheets (PIS) must be stapled together with the consent form when filing proof of consent in your site file. You want to demonstrate what information each patient received when they signed their consent form. Stapling these two documents together allows you to demonstrate the correct version on the PIS and consent form were used with each patient.

5) And finally, do not over stuff you folders, when they are full, get a new folder, label it appropriately and start to file papers in the new folder. We must remember that the state of your site file gives inspectors and auditors a first impression of how we are managing a study and taking care of participants. However, it is not just about first impressions, if inspectors struggle to leaf through files, if they cannot easily turn pages, read individual documents or if documents fall out while the try to read a section of the site file…well, you get the picture.

Full and messy files

Be proud of your site file and how it is kept, schedule time each week to attend to filing and any updates required to keep your site file in top shape.

If it is a reflection of all your hard work…doesn’t it deserve a little R.E.S.P.E.C.T?


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