Links to the current Protocol and Patient Documents are provided below. If there has been a recent amendment to the trial, please ensure you have R&D approval before using these documents.
Other documents (e.g. Case Report Forms, Serious Adverse Event Form, Guidelines, Patient Questionnaires, Amendments, etc.) can be found by clicking on the other menu items below. If you cannot find what you are looking for, please contact the CompARE Trial Office.
- Protocol [.pdf]
- Trial Synopsis [.pdf]
Patient Documents
- Patient Information Sheet E [.pdf]
- Patient Summary Sheet [.pdf]
- Informed Consent Form A [.pdf]
- Informed Consent Form D [.pdf]
- Informed Consent Form CompARE Collect [.pdf]
- GP Letter [.pdf]
- Release of Medical Information Form [.pdf]
Guidelines
- Pharmacy Manual [.pdf]
- SAE Form Completion Guidelines [.pdf]
- Blood and Oral Fluid Sample collection guidelines [.pdf]
- Tissue sample collection guidelines [.pdf]
CRF & eRDC Guidelines:
- CRF Completion Guidelines [.pdf]
- CRF Timeline Guidelines [.pdf]
- eRDC User Manual [.pdf]
- eRDC User Tips - CRF Management [.pdf]
- eRDC User Tips - Navigating [.pdf]
- eCRF Guidelines - Completing the Treatment Toxicity Form (for Arms 1 & 3) [.pdf]
- eCRF Guidelines - Completing the Arm 5 Toxicity Form [.pdf]
Other Trial Documents
- Quality of Life Questionnaires:
- Baseline Questionnaire Pack [.pdf]
- Arm 1, 4 & 5 End of Concomitant Chemoradiotherapy Questionnaire Pack [.pdf]
- Arm 3 End of Dose Escalated Questionnaire Pack [.pdf]
- Arm 4 End of Surgery Questionnaire Pack [.pdf]
- Arm 5 End of Induction Durvalumab Questionnaire Pack [.pdf]
- Arm 5 End of Adjuvant Durvalumab Questionnaire Pack [.pdf]
- Follow-up 3 & 6 Months Questionnaire Pack [.pdf]
- Follow-up 12 & 18 Months Questionnaire Pack [.pdf]
- Summary of Product Characteristics:
- Carboplatin 10mg [.pdf]
- Cisplatin 1mg [.pdf]
Amendments
Below is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.
- Amendment 14, 14-Aug-2018 [opens new page]
- Amendment 03, 07-Dec-2015 [opens new page]
- Amendment 02, 12-Oct-2015 [opens new page]
- Amendment 01, 15-Jul-2015 [opens new page]
Version Control Lists
The version numbers and dates of all documents used for the trial are captured on a Document Version Control List. Links to the Document Version Control Lists used in this trial are below, in reverse date order.
- Version Control List V36 - Investigator Site File [.pdf]
- Version Control List V15 - Pharmacy File [.pdf]