Trial documents

Links to the trial’s current forms and documents are provided below. For any documentation that can not be found on this page, please contact the CATALYST Trial Office.

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

Some of the documents on this page are large files. If you are having issues viewing the documents in your web browser, please right click and ‘Save link as…’ to read them in a PDF viewer such as Adobe Reader.

Trial documents

Trial Protocol and supplementary documents

Patient Documents (English)

Patient Information Sheets & Informed Consent Forms

Please note: all PIS & ICFs should be localised using hospital headed paper.

GP Letters

Please note: all GP Letters should be localised using hospital headed paper.

Other Patient Documents

Patient Documents (Translated)

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



Hindi *

Pashto *




Romanian *



* Please note: The most recent versions of the Information Sheets and Informed Consent Forms are not available in this language. Older versions can NOT be used in substitute. We apologise for any inconvenience.


Investigator's Brochures (IBs) and Summaries of Product Characteristics (SPCs)

The latest Summary of Product Characteristics provided to the CATALYST Trial Office are available below. Please ensure the latest versions are available in both the Investigator Site File and Pharmacy File. Whilst all the latest Investigator’s Brochures and Summary of Product Characteristics are provided to sites immediately for their reference, these will be submitted yearly to the MHRA by substantial amendment on the DSUR deadline in May. Please contact the Trial Office if you require copies of the latest Investigator's Brochures.

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on the Investigator Site File or Pharmacy File Version Control Lists.

Links to these and other Version Control Lists used in this trial are below.

Sample Collection


Pharmacy Documents

Change of Staff

If there are any changes to the staff working on this trial, 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 CATALYST Trial Office (via email). Site specific versions of the SS&DL are available from the CATALYST Trial Office.

Amended documents

Below are links to all of the substantial amendments made to this trial. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

Substantial Amendment Number 1 14_May_2020

Substantial Amendment Number 2 22_May_2020

Substantial Amendment Number 3 5_Jun_2020

Substantial Amendment Number 4 8_Jun_2020

Substantial Amendment Number 5 11_Jun_2020

Substantial Amendment Number 6 18_Jun_2020

Substantial Amendment Number 7 08_Oct_2020