BADBIR / R&D / Site file documents

Site file documents

Access 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Previous version of all site file documents must be stored and marked as superseded, unless your centre registered for BADBIR before the document version was introduced.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 See our Superseded Documents page for a full list of previous versions of our documentation.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.

Contents

Details Version Date
Contents page 20 01/08/2022

Section 1: Protocol

Details Version Date
Protocol 21 26/09/2024

Section 2: PIL

Details Version Date
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) * 2 26/09/2024
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

Details Version Date
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 01/08/2022
Amendment 14 / REC Approval / HRA Approval* 14 26/09/2024
Sponsor Letter 12/07/2007

Section 4: Finance and Contracts

Details Version Date
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

Details Version Date
Waist measurement standard operating procedure 04/05/2010

Section 6: Enrolment log

Details Version Date
Enrolment Log
Original consent forms for patients recruited to BADBIR

Section 7: Study team documentation

Details Version Date
Delegation Log – please note this is stored electronically for each centre within the BADBIR database – more information in News section
CV of Principal Investigator*
CVs of all Investigators (CV Guidance Template)

Section 8: Pathology

Details Version Date
Laboratory ranges

Section 9: Monitoring

Details Version Date
Monitoring Form
Audit Reports*

Section 10: Correspondence and additional forms

Details Version Date
BADBIR Contact Information
Correspondences
Any other relevant study material