CLARITY

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. 

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Delegation Log [.pdf]

Links to the current protocol, Patient Information Sheet, Informed Consent Form are provided below. If there has been a recent amendment to the trial 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, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the CLARITY Trial Office.

• Protocol [.pdf]
• Trial Summary [.pdf]

Patient Documents

• Patient Information Sheet v4.0a [.docx]
• Informed Consent Form v1.0 [.docx] 
• GP Letter  [.docx]
• Release of Medical Information Form [.docx]
• Patient diary weeks 1-8 [.pdf]
• Patient diary weeks 9-15 [.pdf]
• Patient diary months 4-26 [.pdf]

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Investigator Site File Version Control Lists used in this trial are below in reverse date order.

• CLARITY ISF VC Checklist v4.0_02-Sep-2016 [.pdf]
• CLARITY ISF VC Checklist v3.0_12-Jul-2016 [.pdf]
• CLARITY ISF VC Checklist v2.0_27-Apr-2016 [.pdf]
• CLARITY ISF VC Checklist v1.0_09-Mar-2016 [.pdf]

Amendments

Below is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• Summary of Amendments [.pdf] 
• CLARITY Amendments (opens new page)

 Guidelines

• SAE Form Completion Guidelines  [.pdf]
• Informed Consent Guidelines [.pdf]
• Sample Collection Guidelines [.pdf]

Other Trial Documents

• CLARITY FAQ [.pdf] (coming soon)

Case Report Form

Please note that CLARITY has an electronic remote data capture system (eRDC) that will be used instead of a paper CRF.  For further information please contact the CLARITY trial office.

• Entire CRF [.zip]

• Screening Form [.pdf]
• Registration Form[.pdf]
• Eligibility Form [.pdf]
• Treatment Form Day 0 [.pdf]
• Treatment Form Weeks 1-8 [.pdf]
• Treatment Form Weeks 9-15  [.pdf]
• Treatment Form Months 4-26 [.pdf]
• Concomitant Medication Form  [.pdf]
• Adverse Events Form  [.pdf]
• Treatment Discontinuation Form [.pdf]
• Disease Response Form [pdf.]
• Withdrawal Form  [.pdf]
• Notification of Death Form  [.pdf]
• Deviation Form  [.pdf]
• Follow Up Form  [.pdf]
• Pregnancy Notification Form [.pdf]
• SAE Form (electronic)  [.pdf] right click and select 'save link as...' to download

• SAE Fax Cover [.pdf]

Tools

• eRDC Guidelines [.pdf] 

Pharmacy Documents

• Pharmacy Manual [.pdf]
• Ibrutinib order form [.pdf]
• Venetoclax order form [.pdf]
• Ibrutinib SPC (opens a new window)
• Venetoclax SPC (not yet available)

Pharmacy File Version Control Checklists

• CLARITY PF VC Checklist v4.0_09-Jun-2016 [.pdf]
• CLARITY PF VC Checklist v3.0_27-Apr-2016 [.pdf]
• CLARITY PF VC Checklist v2.0_22-Apr-2016 [.pdf]
• CLARITY PF VC Checklist v1.0_09-Mar-2016 [.pdf]

To date there are no publications available for this trial.  

CLARITY News

Trial Milestones

CLARITY opened to recruitment on 20-May-2016.  The first patient was registered to CLARITY on 09-June-2016 and patient 10 was registered on 26-Jul-2016.

Newsletters

• CLARITY Newsletter - September 2016 [.pdf]
• CLARITY Newsletter - July 2016 [.pdf]
• CLARITY Newsletter - May 2016 [.pdf]

Chief Investigator

Professor Peter Hillmen
Department of Haematology
Level 3, Bexley Wing
St James's University Hospital
Beckett Street 
Leeds, LS9 7TF

Tel:      +44 (0)113 206 8513

CLARITY Trial Office

Trial Coordinator:         Yolande Jefferson                        
Trial Monitor:                Tanzeem Begum                              
Trial Management Team Leader:  Shamyla Siddique                                
                

Cancer Research UK Clinical Trials Unit (CRCTU)
Department of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Enquiries
Telephone: +44 (0)121 415 9179
Email:         CLARITY@trials.bham.ac.uk

Trial Entry
Telephone: +44 (0)121 415 9180 (9:00 to 5:00 pm Monday to Friday)

Serious Adverse Event Reporting
Fax: +44 (0)121 414 6061  or +44 (0)121 414 3700

Sponsor: University of Birmingham