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 PAZ02 Trial Office.
- Trial protocol [.pdf]
- Patient Information Sheet [.pdf]
- Informed Consent Form [.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.
- Document Version Control V7.0 [.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.
- Amendment 1
- Amendment 2
- Amendment 3
- Amendment 4
- Amendment 5
- Amendment 6
- Amendment 7
- Amendment 8
- Amendment 9
- Amendment 10
- Amendment 11
- Amendment 12
- Amendment 13
- Amendment 14
- Amendment 15
- Amendment 16
- Amendment 17
Case Report Form
- CRF version control checklist v9.0 [.pdf]
- Eligibility Checklist v2.1 [.pdf]
- Registration form v2.1 [.pdf]
- Baseline form v5.1 [.pdf]
- Treatment Forms
- Week 2 v7.1 [.pdf]
- Week 4 v7.1 [.pdf]
- Week 6 v7.1 [.pdf]
- Week 8 v7.1 [.pdf]
- 4 Weekly v7.1 (Week 12 onwards treatment form) [.pdf]
- End of Treatment Form v7.1 [.pdf]
- 3 Monthly Follow Up Form v7.1 [.pdf]
- Death Form v1.1 [.pdf]
- Deviation Form v2.1 [.pdf]
- Withdrawal Form v3.1 [.pdf]
- Pregnancy Notification Form v1.1 [.pdf]
- Disease Progression Form v5.1 [.pdf]
- SAE Form v1.1 [.pdf]
- SAE Fax Cover Sheet v3.1 [.pdf]
Guidelines
- CRF Completion Guidelines v1.0 [.pdf]
- SAE Form Completion Guidelines v1.0 [.pdf]
Other Trial Documents
- Pharmacy Manual v2.0 [.pdf]
- SmPC Pazopanib dated 06-Aug-2015 [.pdf]