Welcome to the DARLO-C study reference page. On this page, you will find links to a selection of the current study documents including reference materials, logs and training.
When documents are updated, you will receive email notification that the updated version is available for download at the study reference page. If you require paper copies printed please contact the Clinical Project Coordinator on darlo-c@kirby.unsw.edu.au.
Some items on this page are password protected for confidentiality reasons, please access using the password provided to you from your Clinical Project Coordinator.
Study documents:
- Protocol, version 3.0, dated 31 January 2017
- Elbasvir/grazoprevir product information, dated 16 January 2017
- VHCRP manual of operations – DARLO-C study-specific supplement, version 1.0, dated 20 April 2017
- VHCRP local laboratory manual – DARLO-C study-specific supplement, version 1.0, dated 20 April 2017
- Finger-stick xpert HCV point of care test manual, version 1.0, dated 28 March 2017
- Finger-stick xpert HCV point of care flow chart, version 1.0, dated 28 March 2017
- Finger-stick xpert HCV point of care maintenance log, version 1.0, dated 28 March 2017
- Instructions for android tablets, version 1.0, dated 23 March 2017
Study tools:
- Site signature and study responsibilities log, version 1.0, 26 October 2016
- Site staff training log, version 1.0, dated 26 October 2016
- Master participant enrolment log, version 1.0, dated 24 October 2016
- Monitoring visit log, version 1.0, dated 25 October 2016
- Patient reimbursement tracking log, version 1.0, dated 6 March 2017
- Source proforma, version 2.0, dated 28 March 2017
- Eligibility criteria checklist, version 2.0, dated 28 March 2017
- Concomitant medications log, version 1.0, dated 18 January 2017
- Site research specimen collection log, version 1.0, 18 January 2017
- Protocol exemption form, version 1.0, dated 25 October 2016
- Investigator site file – file note template, version 1.0, dated 26 October 2016
- DARLO-C SAE form, version 3.0, dated 11 January 2017
- MSD SAE fax cover sheet reporting
Questionnaires:
- Behavioural questionnaire for screening visit, version 3.0, dated 30 January 2017
- Behavioural questionnaire for follow-up visits, version 2.0, dated 17 November 2016
- EQ-5D questionnaire, version 1.0, dated 13 January 2015
- Adherence questionnaire, version 1.0, dated 13 October 2016
Please open documents in Internet Explorer or Google Chrome (some formatting issues are noted with Firefox). If you require Word versions of any of the documents, please contact the project coordinator.