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.
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.
* 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.
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.