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 CLARITY Trial Office.
- Protocol [.pdf]
- Trial Summary [.pdf]
Patient Documents
- Patient Information Sheet v4.0a [.docx]
- Informed Consent Form v1.0 [.docx]
- GP Letter [.docx]
- Release of Medical Information Form [.docx]
- Patient diary weeks 1-8 [.pdf]
- Patient diary weeks 9-15 [.pdf]
- Patient diary months 4-26 [.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 Investigator Site File Version Control Lists used in this trial are below in reverse date order.
- CLARITY ISF VC Checklist v4.0_02-Sep-2016 [.pdf]
- CLARITY ISF VC Checklist v3.0_12-Jul-2016 [.pdf]
- CLARITY ISF VC Checklist v2.0_27-Apr-2016 [.pdf]
- CLARITY ISF VC Checklist v1.0_09-Mar-2016 [.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
- SAE Form Completion Guidelines [.pdf]
- Informed Consent Guidelines [.pdf]
- Sample Collection Guidelines [.pdf]
Other Trial Documents
- CLARITY FAQ [.pdf] (coming soon)