RadIO: For Investigators

• Investigator Registration Form [PDF 204kb]
• Site Signature and Delegation Log [PDF 51kb]
• Site Staff Registration Form [PDF 176kb]
• Training Log [PDF 36kb]

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.

If you cannot find what you are looking for please contact the Radio Study Office.

• Protocol [PDF 1960kb]
• Study Summary [PDF 905kb]
• Patient Information Sheet  [PDF 863kb]
• Informed Consent Form [PDF 578kb]
• GP Letter [PDF 519kb]

Version Control Lists

The version numbers and dates of all documents currently used for the study are captured on a document version control list.

• Document Version Control - Basic Sites [PDF 202kb]
• Document Version Control - In-depth Translational Sites [PDF 204kb] 

Case Report Forms

• AE Monitoring [PDF 254kb]
• Assessments [PDF 67kb]
• Baseline Form [PDF 101kb]
• Chemotherapy Treatment Form [PDF 176kb]
• Cystectomy Form [PDF 58kb]
• Cystoscopy Form [PDF 58kb]
• Death Form [PDF 59kb]
• Deviation Form [PDF 62kb]
• Durvalumab Treatment Toxicity Form [PDF 161kb]
• Durvalumab Treatment Form [PDF 146kb]
• Eligibility Form Checklist [PDF 118kb]
• End of Treatment Form [PDF 63kb]
• Follow-Up Form [PDF 68kb]
• Hepatic Function Abnormality Form [PDF 61kb]
• Local Recurrence Form [PDF 76kb]
• Metastatic Disease Form [PDF 55kb]
• Pregnancy Notification Form [PDF 60kb]
• Previous Treatment Form [PDF 62kb]
• Radiotherapy Treatment Form [PDF 137kb]
• Randomisation Form [PDF 104kb]
• Second Primary Cancer Form [PDF 53kb]
• Withdrawal Form [PDF 71kb]

Patient Questionnaires

• LENT/SOMA Female Patient Booklet [PDF 243kb]
• LENT/SOMA Male Patient Booklet [PDF 239kb]
• QoL Questionnaires Booklet [PDF 225kb]

Guidelines

• General CRF Completion Guidelines [PDF 192kb]
• Guidelines for Site Staff on Informed Consent Procedures [PDF 44kb]
• RTTQA Guidelines [PDF 826kb]
• SAE Form Completion Guidelines [PDF 85kb]
• eRDC User Manual [PDF 1433kb]

Sample Collection

• FFPE Tissue Block Collection Manual [PDF 88kb]
•  In-depth Blood Collection Tracking Form [PDF 61kb]
•  In-depth Urine Collection Tracking Form [PDF 89kb]
• Tissue Block Collection Tracking Form [PDF 86kb]
• In-depth Translational Sub-studies Manual [PDF 2399kb]

Other Study Documents

• SAE Form  [PDF 278 kb]

No publications currently.

There are no current news or events for this study.

Chief Investigator

Professor Nicholas James                                          
The Institute of Cancer Research, London SW3 6JB 

Tel: 020 7153 5130 

RadIO Study Office

Trial Coordinator:  Ms Baljit Kaur & Anne-Marie Hodgkins
Trial Monitor:  Ms Davina Scott

Trial Management Team Leader:  Ms Sophia Magwaro
Trial Statistician:  Dr Wenyu Liu

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

Enquiries

Telphone: +44 (0) 121 414 3793 
Fax: +44 (0) 121 414 2230
Email: RadIO@trials.bham.ac.uk                                                                                                                                                                   

Website 

www.birmingham.ac.uk/Radio 

Randomisation

www.cancertrials.bham.ac.uk

Emergency Randomisation  

0121 414 3793 or 0121 415 8544 * RadIO@trials.bham.ac.uk

Serious Adverse Event Reporting

Email to: reg@trials.bham.ac.uk

cc. RadIO@trials.bham.ac.uk      

Sponsor

The University of Birmingham