BADBIR Site File
This page details all the documentation required for a completed BADBIR site file. The items marked with a * would be local to each individual Trust so please contact the BADBIR office for your localised version.
It is the responsibility of each centre to keep their site file fully up-to-date. In addition to the complete documentation there is also a requirement to store all original consent forms and CVs for all research team members.
The contents page for the site file can be downloaded here
| Section |
Documents |
| Section 1: Protocol | Protocol V13 (14/05/2009) - inc. Chief Investigator signature on p.1 Click here
Previous versions of the protocol should be marked as superceded |
| Section 2: PIL | Patient Information Sheet V4 (14/05/2009) Click here*
Patient Consent Form V4 (14/05/2009) *Click here
Patient Information Letter V1 (25/02/2011) *Click here
Previous versions of the information sheet and consent form should be marked as superceded |
| Section 3: Regulatory & Other Essential Documents | Main NHS MREC Application Form (inc. CI and Sponsor signature) Click here
Main NHS REC Approval Letter Click here
SSI form including signature page(s)*
Trust approval letter*
Notice of Substantial Amendment 1 Click here and Approval Click here
Notice of Substantial Amendment 2 Click here and Approval(s*) Click here
Notice of Substantial Amendment 3 Click here and Approval(s*) Click here
Notice of Substantial Amendment 4 Click here and Approval(s*) Click here
Notice of Substantial Amendment 5 Click here and Approval(s*) Click here
Notice of Substantial Amendment 6 Click here and Approval(s*) Click here
Sponsor Letter Click here
|
| Section 4: Finance and Contracts | BADBIR Centre Agreement (inc. date 1st page and signature page)*
Amendment to Centre Agreement (if applicable)*
Appendix 4 - Stakeholders Responsibilities Click here
BADBIR Arrangements to Receive Study Payments' Form Click here
|
| Section 5: SOPs | Waist Measurement Standard Operating Procedure Click here
|
| Section 6: Enrolment Log | Enrolment Log Click here
Original Consent Forms for patients recruited to BADBIR
|
| Section 7: Study Team Documentation | Delegation Log Click here
CV of Principal Investigator*
CVs of all Investigators (template available here)
Team Addition Forms for staff not listed on original SSI form (blank form available here)
|
| Section 8: Pathology | No documentation available at present
|
| Section 9: Monitoring | Monitoring Form Click here
Audit Reports*
|
| Section 10: Correspondence & Additional Forms | BADBIR Contact Sheet Click here
Correspondences
Any other relevant study material
|