Welcome to SMART-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 smartc@kirby.unsw.edu.au.
Some items on this page are password protected for confidentiality reasons, please access using the password provided to you by your Clinical Project Coordinator.
Study documents
- Investigator’s Brochure for Glecaprevir/Pibrentasvir, Edition 2, dated 6 September 2016
- Investigator’s Brochure for Glecaprevir/Pibrentasvir, Edition 3, dated 29 August 2017
- Investigator’s Brochure for Glecaprevir/Pibrentasvir – Addendum 1, Edition 2, dated November 2016
- VHCRP Manual of Operations, version 1.0, dated 20 April 2017
- VHCRP Manual of Operations – SMART-C Study Specific Supplement, version 1.0, dated 15 August 2017
- Protocol, version 2.0, dated 14 June 2017
Approved for the United Kingdom only
- Protocol, version 2.0, 21 July 2017
Study tools & logs
- Site Signature and Study Responsibilities Log, version 1.0, dated 19 July 2017
- Site Staff Training Log, version 1.0, dated 15 June 2017
- Master Participant Enrolment Log, version 1.0, dated 15 June 2017
- Source Proforma, version 3.0, dated 7 March 2017
- Eligibility Criteria Checklist, version 1.0, dated 12 July 2017
- Concomitant Medication Log, version 1.0, dated 12 July 2017
- Adverse Events Log, version 1.0, dated 12 July 2017
- Site Research Specimen Collection Log, version 1.0, 20 June 2017
- Participant Reimbursement Log, version 1.0, dated 15 June 2017
- Monitoring Log, version 1.0, dated 15 June 2017
- Protocol Exemption Form, version 1.0, dated 15 June 2017
- SAE Form, version 2.0, dated 2 August 2017
- SAE Version (eVersion), version 2.0, dated 2 August 2017
- Investigator Site File – File Note Template, version 1.0, dated 22 May 2017
- Product Complaint Form, version 1.0, dated 6 September 2017
- Pregnancy Report Form, version 1.0, dated 6 September 2017
Questionnaires
Approved for ALL study sites.
- Practitioner Acceptability Questionnaire for Pre-Screening, version 1.0, dated 31 May 2017
- Practitioner Acceptability Questionnaire for Post-Treatment, version 1.0, dated 31 May 2017
NOTE: Please refer to your ethics approval documentation for the approved version numbers of the documents to be used or contact your project coordinator.
English (For Australia, New Zealand, United States, United Kingdom and Canada)
- EQ-5D-3L, 31 May 2017
- Participant Satisfaction Questionnaire for Screening, version 1.0, dated 31 May 2017
- Participant Satisfaction Questionnaire for SVR12, version 2.0, dated 4 April 2018
- Phone-Based Visit Questionnaire, version 1.0, dated 31 May 2017
- Phone-Based Visit Questionnaire, version 2.0, dated 4 August 2017 (Australia, New Zealand, United Kingdom and St Joseph Healthcare Hamilton, Canada only)
French Canadian (For Quebec and Montreal)
- EQ‐5D‐3L, 7 July 2017
- Participant Satisfaction Questionnaire for Screening, version 1.0, dated 31 May 2017
- Participant Satisfaction Questionnaire for SVR12, version 2.0, dated 4 April 2018
French (For France)
- EQ-5D-3L_French, dated 7 July 2017
- Participant Satisfaction Questionnaire for Screening_French, version 1.0, dated 31 May 2017
- Participant Satisfaction Questionnaire for SVR12_French, version 2.0, dated 4 April 2018
- Phone-Based Visit Questionnaire_French, version 2.0, dated 4 August 2017
German (For Switzerland and Germany)
- EQ-5D-3L_German, dated 7 July 2017
- Participant Satisfaction Questionnaire for Screening_German, version 1.0, dated 31 May 2017
- Participant Satisfaction Questionnaire for SVR12_German, version 2.0, dated 4 April 2018
- Phone-Based Visit Questionnaire_German, version 2.0, dated 4 August 2017
Laboratory
- VHCRP Local Laboratory Manual, version 1.0, dated 20 April 2017
- VHCRP Local Laboratory Manual – SMART-C Study Specific Supplement, version 1.0, dated 17 August 2017
- LabKey Training Video (Please access using the Training link below)
Pharmacy
- VHCRP Pharmacy Manual, version 1.0, dated 27 April 2017
- VHCRP Pharmacy Manual – SMART-C Study Specific Supplement, version 1.0, dated 9 August 2017
- Pharmacy Signature and Study Responsibilities Log, version 1.0, dated 14 June 2017
- Master IP Accountability Log, version 1.0, dated 15 June 2017
- Pharmacy Master Participant Log, version 1.0, 15 June 2017
- Internal Quality Assurance Review, version 1.0, 9 January 2017
- IP Storage Temperature Deviation Notification Form, version 2.0, dated 9 August 2017
GCP training
- ICH Harmonised Guideline - Integrated Addendum to ICH E6(R2): Guideline for Good Clinical Practice
- GCP Training Video (Please access using the Training link below)
eCRF training
- OpenClinica Manual, version 2.0, 22 June 2012
- OpenClinica Training Video (Please access using the Training link below)
*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 on smartc@kirby.unsw.edu.au.