Study Documents

Links to the current protocol, patient documents, and all other study related documents are provided below. Please contact the BRAIN MATRIX Study Office if you cannot find the document you are looking for. 

If there has been a recent amendment to the study please ensure that you have obtained R&D approval before using the updated versions of these documents. 

All documents require a username and password login to access - please contact the Study Office if you require these. 

Changes of Staff

If there are any changes to the staff working on this study, please complete the relevant Staff Registration Form below. Please also ensure that the Site Signature and Delegation Log (SS&DL) is updated, and return both documents to the BRAIN MATRIX Study Office. 

Study Documents

Study Protocol Documents

Patient Documents

Please note: all PIS & ICFs, and the GP Letter, should be localised using hospital headed paper.

Sample Collection

Imaging

Other Study Specific Guidance

Data Collection

Pharmacovigilance

Version Control Lists

The version numbers and dates of all documents used for the study are captured on the Investigator Site File Version Control List:

  • Investigator Site File Version Control List

Regulatory & Amendments

Regulatory Approvals

Amendments

Below are links to all of the substantial amendments made to this study. The folders contain all of the relevant amended documentation and approval letters.  Please ensure that you have local R&D approval (if applicable) before using the latest versions of these documents.

Currently no amendments have been made.