麻豆精选

Trial Protocol and supplementary documents

•  [1.18MB PDF]
•  [252Kb PDF]

Patient Documents (English)

Patient Information Sheets & Informed Consent Forms

•  [198Kb PDF]
•  [167Kb PDF]
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•  [133Kb PDF]
•  [137Kb PDF]
•  [136Kb PDF]

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

GP Letters

• [106Kb PDF]

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

Other Patient Documents

• [111Kb PDF]
• [116Kb PDF]
• [172Kb PDF]

Patient Documents (Translated)

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

Bengali

•  [59Kb DOC]
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French

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Hindi *

•  [700Kb DOC]
•  [55Kb DOC]
•  [27Kb DOC]

Pashto *

• [677Kb DOC]
• [54Kb DOC]
•  [27Kb DOC]

Polish

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Portuguese

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• [21Kb DOC]

Punjabi

• [57Kb DOC]
• [51Kb DOC]
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• [677Kb DOC]
• [55Kb DOC]
• [28Kb DOC]

Romanian *

• [700Kb DOC]
• [51Kb DOC]
• [23Kb DOC]

Urdu

• [54Kb DOC]
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• [48Kb DOC]
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• [25Kb DOC]

Welsh

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• [57Kb DOC]
• [27Kb DOC]

* 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.

Pharmacovigilance

• [766Kb PDF]
• [325Kb PDF]

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.

• Arm 2: [242Kb PDF]
• Arm 3: Namilumab: Investigator Brochure: Please contact the CATALYST Trial Office
• Arm 4: [215Kb PDF]

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.

•  [28Kb DOC]
•  [23Kb DOC]

Sample Collection

• [273Kb PDF]

Guidelines

• [2.70Mb PDF]

Pharmacy Documents

•  [449Kb PDF]
• [573Kb PDF]
• [470Kb PDF]
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• [244Kb PDF]
• [914Kb PDF]

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.

• [621Kb PDF]
• [553Kb PDF]
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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

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• [249Kb PDF]
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Substantial Amendment Number 2 22_May_2020

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Substantial Amendment Number 3 5_Jun_2020

• [51Kb PDF]
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• [310Kb PDF]

Substantial Amendment Number 4 8_Jun_2020

• [46Kb PDF]
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Substantial Amendment Number 5 11_Jun_2020

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Substantial Amendment Number 6 18_Jun_2020

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Substantial Amendment Number 7 08_Oct_2020

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