Links to the current protocol, patient information sheet, informed consent form are provided below. If there has been a recent amendment to the study 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 etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the ANICCA-Class II study office.
- Protocol v6.0 24-Aug-2021 [PDF 1.53Mb]
- Protocol Signature Page [PDF 53Kb]
- Study Summary v2.0 04-Jun-2020 [PDF 687Kb]
- Patient Information Sheet Screening v4.0 30-mar-2020 [PDF 194Kb]
- Patient Information Sheet Main Trial v6.0 18-May-2020 [PDF 1.07Mb]
- Informed Consent Form Screening v3.0 30-Mar-2020[PDF 42Kb]
- Informed Consent Form Main Trial v3.0 30-Mar-2020[PDF 70Kb]
- GP Letter v2.0 18-May-2020 [PDF 52Kb]
- Release of Medical Information Form v4.0 30-Mar-2020[PDF 72Kb]
Version Control Lists
The version numbers and dates of all documents currently used for the study are captured on a document version control lists below:
- ISF Main Documents Version Control List [PDF 293Kb]
- PSF Main Documents Version Control List [PDF 257Kb]
Case Report Form
Links to the current CRF are provided below.
- Adverse Event Form [PDF 694Kb]
- Concomitant Medication Log [PDF 451Kb]
- Death Form [PDF 488Kb]
- Deviation Form [PDF 422Kb]
- Eligibility checklist [PDF 143Kb]
- End of treatment Form [PDF 108Kb]
- Follow Up Form [PDF 240Kb]
- Laboratory Tests Form [PDF 716Kb]
- Medical History Form [PDF 524Kb]
- MS status and Class II expression results Form [PDF 641Kb]
- Pregnancy Notification Form [PDF 386Kb]
- Previous Cancer treatment Form [PDF 241Kb]
- Response Evaluation Form Baseline [PDF 137KB]
- Response Evaluation Form [PDF 584Kb]
- Safety Follow up Visit Form [PDF 700Kb]
- Screening Biopsy Form [PDF 115Kb]
- Screening Form [PDF 718Kb]
- Screening Registration Form [588Kb]
- Treatment Discontinuation Form [PDF 680Kb]
- Treatment Form [PDF 460Kb]
- Trial entry Form [PDF 476Kb]
- Withdrawl Form [PDF 327Kb]
Pharmacy Documents
- Pharmacy Manual[PDF 1.19Mb]
- Nivolumab Investigator Brochure V18 [PDF 12.98Mb]
- Nivolumab SmPC [PDF 1.20Mb ]
- Nivolumab Patient Drug Accountability Log [PDF 62Kb]
- Nivolumab Master Drug Accountability Log [PDF 62Kb]
- Drug Order Form [PDF 129Kb ]
- Temperature Deviation Form [PDF 87Kb]
Guidelines
- CRF Guidelines [PDF 307Kb]
- Nivolumab Patient Accountability Log Instructions [PDF 45Kb ]
- Nivolumab Master Accountability Log Instructions [PDF 47Kb]
- SAE Form Completion Guide [PDF 98Kb]
Other Study Documents