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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Previous versions of all site file documents should be stored and marked as superseded, unless your centre registered for the BSRBR-RA after the document version was introduced.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 Please contact us if you have any queries regarding superseded versions of any site file documentation.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 awould be local to each individual Trust. These forms are in Microsoft Word format where appropriate to enable your centre to prepare them locally.

Section 1: Protocols

DetailsVersionDate

Main Study Protocol

 N/A 06/10/2003
Tocilizumab sub-study protocol  1.1 17/01/2011
Certolizumab sub-study protocol  3 15/11/2010

Section 2: Regulatory and other essential documents

DetailsVersionDate

Main NHS MREC application

N/A 26/07/2000
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

N/A 27/11/2003

Substantial amendment 3 and approval

N/A 13/12/2004

Substantial amendment 4 and approval 

N/A 10/04/2006

Substantial amendment 5 and approval 

N/A 12/06/2006

Substantial amendment 6 and approval

N/A 30/01/2007

Substantial amendment 7 and approval

N/A 14/03/2007

Substantial amendment 8 and approval

N/A 11/05/2007

Substantial amendment 9 and approval

N/A 21/09/2007

Substantial amendment 10 and approval

N/A 06/05/2008

Substantial amendment 11 and approval

N/A 21/07/2008

Substantial amendment 12 and approval

N/A 04/09/2009

Substantial amendment 13 and approval

N/A 04/08/2010

Substantial amendment 14 and approval

N/A 10/09/2010

Substantial amendment 15 and approval

N/A 20/12/2010

Substantial amendment 16 and approval

N/A 30/06/2011

Substantial amendment 17 and approval

N/A 22/11/2011

Substantial amendment 18 and approval

N/A 13/06/2012

Substantial amendment 19 and approval

N/A 12/09/2014

Section 4: Patient master file

DetailsVersionDate

Patient Screening Log

1 06/01/2015

Copies of consent forms (another copy to be kept in the patient notes)*

   

Section 5: Study team documentation

DetailsVersionDate

Delegation log

   

CV of Principal Investigator and other staff working on the study*

   

Section 7: Correspondence and additional forms

DetailsVersionDate

BSRBR-RA contact information

   

Correspondence

Any other relevant study material