Site file documents
Here you will find all of the documents required for the study site file, as well as other core BSRBR-RA study documents.
It is the responsibility of each centre to keep their site file fully up-to-date. All consent forms and CVs for research team members must also be stored in the site file.
Previous versions of all site file documents should be stored and marked as superseded, unless your centre registered for the BSRBR-RA after the document version was introduced. For simplicity, the table below only contains the latest documents required in the site file. Please contact us if you have any queries regarding superseded versions of any site file documentation.
Site file structure
This table contains the latest documents for the site file. Items marked with a* would be local to each individual Trust. These forms are in Microsoft Word format where appropriate to enable your centre to prepare them locally.
|Original MREC approval letter||N/A||01/12/2000|
|SSI form including signature page(s)*
Trust approval letter*
|Substantial amendment 1 and approval||N/A||21/05/2003|
Substantial amendment 2 and approval
|Substantial amendment 25 and approval||N/A||24/08/2017|
|Substantial amendment 26 / REC approval / HRA approval||N/A||12/10/2018|
|Substantial amendment 27 / REC approval / HRA approval||N/A||24/12/2018|
|Substantial amendment 28 / REC approval / HRA approval||N/A||19/05/2021|
|Substantial amendment 29 / REC approval / HRA approval||N/A||22/09/2022|
|Sponsor confirmation of insurance letter||N/A||15/03/2012|
|BSRBR-RA Stakeholder Responsibilities||1||05/12/2018|
|Patient Transparency Information Sheet||1||18/05/2018|
Copies of consent forms (another copy to be kept in the patient notes)*
CV of Principal Investigator and other staff working on the study*