Links to the current protocol, Patient Information Sheet, Informed Consent Form 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. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the ROMAZA Trial Office.
- Protocol [.pdf]
- Trial Summary [.pdf]
Patient Documents
- Patient Information Sheet [.docx]
- Informed Consent Form [.docx]
- GP Letter [.pdf]
- Release of Medical Information Form [.docx]
- Patient Screening and Enrolment log [.pdf]
- Patient Identification Log [.pdf]
Version Control Lists
The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Version Control Lists used in this trial are below in reverse date order.
- Version Control Checklist - Investigator Site Folder [.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.
Guidelines
- CRF Completion Guidelines [.pdf]
- SAE Form Completion Guidelines [.pdf]
Other Trial Documents