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 Bubble Trial Office.
- Protocol v3.0 [.pdf]
- Patient Information Sheet and Consent Form v3.0 [.docx]
- Release of Medical Information Form v1.0 [.docx]
- GP Letter v2.0 [.docx]
- Patient Cards v1.0 [.pdf]
- Patient Diary v2.0 [.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.
- Investigator Site Version Control List v7.0 [.pdf]
- Investigator Site Version Control List v6.0 [.pdf]
- Investigator Site Version Control List v5.0 [.pdf]
- Investigator Site Version Control List v4.0 [.pdf]
- Investigator Site Version Control List v3.0 [.pdf]
- Investigator Site Version Control List v2.0 [.pdf]
- Investigator Site Version Control List v1.0 [.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]
- Sample Collection Guidlines [.pdf]
- Self Rating Mood Scale Booklet v1.0 [.pdf]
Other Trial Documents
- Quality of Life Questionnaire [.pdf]
- PI Protocol Signature sheet [.pdf]