Chief Investigator: Prof Andrew Bradbury

MREC number: 15/NS/0070

BASIL-3 Version control Document – keep at front of Site File

THE MOST UP-TO-DATE VERSION OF EACH DOCUMENT MUST BE PLACED UPPERMOST IN THE FILE – Retain all earlier versions for audit purposes and mark: ‘Superseded by Version (No) on (date)’ to avoid accidental use of wrong version.

protocol

VERSION No. / DATE / DATE APPROVED BY ETHICS / DATE APPROVED BY R&D /HRA / DATE IMPLEMENTED / COMMENTS e.g. date new version sent to co-investigator or to participating sites, acknowledgement of receipt, etc
1.0 / 10th August 2015 / 26 AUG 2015
2.0 / 22nd Jan 2016 / 16 Feb 2016 / 10 Mar 2016 / 13 Apr 2016
3.0 / 22 Jun 2017 / 10 Aug 2017 / 15 Sep 2017 / 15 Sep 2017 / Implemented 11 Sep 2017 in the devolved nations

PARTICIPANT INFORMATION SHEET

VERSION No. / DATE / DATE APPROVED BY ETHICS / DATE APPROVED BY R&D / DATE IMPLEMENTED / COMMENTS e.g. date new version sent to co-investigator or to participating sites, acknowledgement of receipt, etc
1.0 / 14 August 2015 / 26 AUG 2015

PARTICIPANT CONSENT FORM

VERSION No. / DATE / DATE APPROVED BY ETHICS / DATE APPROVED BY R&D / DATE IMPLEMENTED / COMMENTS e.g. date new version sent to co-investigator or to participating sites, acknowledgement of receipt, etc
1.1 / 14 August 2015 / 26 AUG 2015

GP INFORMATION SHEET

VERSION No. / DATE / DATE APPROVED BY ETHICS / DATE APPROVED BY R&D / DATE IMPLEMENTED / COMMENTS e.g. date new version sent to co-investigator or to participating sites, acknowledgement of receipt, etc
0.2 / 14 August 2015 / 26 AUG 2015
1.0 / 22nd Jan 2016 / 16 Feb 2016 / 10 Mar 2016 / 13 Apr 2016

Validated Questionnaire: Patient Completed Booklet

VERSION No. / DATE / DATE APPROVED BY ETHICS / DATE APPROVED BY R&D / DATE IMPLEMENTED / COMMENTS e.g. date new version sent to co-investigator or to participating sites, acknowledgement of receipt, etc
1.0 / 25 Jun 2015 / 26 AUG 2015
1.1 / 02 Mar 2016 / 24 Jun 2016 / 24 Jun 2016
2.0 / 22 Jun 2017 / 10 Aug 2017 / 15 Sep 2017 / 15 Sep 2017 / Implemented 11 Sep 2017 in the devolved nations

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