Site File Documents

Here are all of the documents required for the study site file, as well as other core BADBIR study documents.

It is the responsibility of each centre to keep their site file fully up-to-date. All original consent forms and CVs for research team members must also be stored in the site file.

Previous version of all site file documents must be stored and marked as superseded, unless your centre registered for BADBIR before the document version was introduced. For simplicity, the table below only contains the latest documents required in the site file. See our Superseded Documents page for a full list of previous versions of our documentation.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. We usually prepare these documents for new centres, but the forms are in Microsoft Word format to enable your centre to prepare these documents if you'd prefer.

Section Details Version Date
Contents Contents page 20 01/08/2022
Section 1: Protocol Protocol 20 01/08/2022
Section 2: PIL Participants over 16 years of age:
Patient Information Sheet
(Word version)* 		5.3 01/08/2022
Patient Consent Form
(Word version)* 		5.3 01/08/2022
Patient Invitation Letter* 2 01/06/2020
Patient Portal Invitation Letter
(Word version)* 		1 01/08/2022
Participants under 16 years of age:
Patient Assent Form
(Word version)* 		5.3 01/08/2022
Participant Consent Form (parent or guardian)
(Word version)* 		5.3 01/08/2022
Participant Information Sheet (for children)* 2.2 01/08/2022
Participant Information Sheet (for young children)* 2.2 01/08/2022
Participant Information Sheet (for very young children)* 2.2 01/08/2022
Section 3: Regulatory and other essential documents Main NHS MREC Application Form (including CI & Sponsor signatures)
Main NHS REC Approval Letter 14/03/2007
SSI Form including signature page(s)*
Trust Approval Letter*
Amendment 1 and approval* 1 12/03/2008
Amendment 2 and approval* 2 15/01/2008
Amendment 3 and approval* 3 12/09/2008
Amendment 4 and approval* 4 30/11/2009
Amendment 5 and approval* 5 05/05/2011
Amendment 6 and approval* 6 16/02/2012
Amendment 7 and approval* 7 28/12/2012
Amendment 8 and approval* 8 28/09/2015
Amendment 9 and approval* 9 13/01/2016
Amendment 10 / REC Approval* / HRA Approval 10 11/09/2017
Amendment 11 / REC Approval* / HRA Approval 11 31/08/2018
Amendment 12 / REC Approval* / HRA Approval 12 26/08/2020
Non-substantial amendment, July 2021 / HRA Acknowledgement 12 15/07/2021
Amendment 13 / REC Approval* / HRA Approval 13 19/01/2023
Sponsor Letter 12/07/2007
Section 4: Finance and Contracts BADBIR Centre Agreement (including dated 1st page and signature page)*
Amendment to Centre Agreement (if applicable)*
Appendix 4 - Stakeholder Responsibilities 2 06/01/2009
BADBIR arrangements to receive study payments form
Section 5: SOPs Waist measurement standard operating procedure 04/05/2010
Section 6: Enrolment log Enrolment Log
Original consent forms for patients recruited to BADBIR
Section 7: Study team documentation Delegation Log - please note this is stored electronically for each centre within the BADBIR database - more information
CV of Principal Investigator*
CVs of all Investigators (here's a template)
Section 8: Pathology Laboratory ranges
Section 9: Monitoring Monitoring Form
Audit Reports*
Section 10: Correspondence and additional forms BADBIR Contact Information
Correspondences
Any other relevant study material