SMALL Trial 

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. Return both documents to the SMALL Trial Office.

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

Links to the current Protocol and Patient Documents are provided below. If there has been a recent amendment to the trial, please ensure you have R&D approval before using these documents.

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

Other documents (e.g. Case Report Forms, Guidelines, Amendments, etc.) can be found by clicking on the other menu items below. If you cannot find what you are looking for, please contact the SMALL Trial Office.

Patient Documents

Note: Please contact the SMALL Trial Office for word document versions of these Patient Documents for localisation. 

• • • Introductory Patient Information Leaflet [.pdf]
    • Patient Information Sheet [.pdf]
    • Information Study Patient Information Leaflet [.pdf]
    • Informed Consent Form [.pdf]
    • Information Study - Patient ICF [.pdf]
    • GP Letter [.pdf]

 

Healthcare Professional Documents 

Note: Please contact the SMALL Trial Office for word document versions of these Healthcare Professional Documents for localisation. 

• • • HCP Information Sheet [.pdf]
    • HCP Consent Form [.pdf]
    • Information Study - Verbal Consent Record [.pdf]

 

Guidelines 

• • • Radiology Manual [.pdf]
    • Tissue Sample Guidelines [.pdf]
    • SAE Form Completion Guidelines [.pdf]

 

CRF & eRDC Guidelines

• • • Site Randomisation eRDC Manual [.pdf]
    • Site eRDC Manual [.pdf]
    • Data Entry Tips Postcard [.pdf]

 

Other Trial Documents 

• • • Baseline Quality of Life Questionnaire [.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.

• • • Substantial Amendment 01, 18-Dec-2020 [.pdf]
    • Substantial Amendment 01 Cover Letter [.pdf]
    • REC Approval Letter [.pdf]
    • HRA and HCRW Approval Letter [.pdf]

 

Version Control Lists 

• • • ISF Control List [.pdf] 

Chief Investigator: Professor Stuart McIntosh

Tel: +44 (0) 2890 972986

SMALL Trial Office 

Senior Trial Coordinator: Mrs Elizabeth Southgate
Trial Coordinator: Dr Jessica Foster  
Data Manager: Miss Hafsa Ibrar 

Trial Monitor:  Dr Emily Taylor
Trial Management Team Leader:  Miss Claire Gaunt
Trial Statistician: Miss Amanda Kirkham

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

Enquiries

Tel: +44 (0) 121 414 3017
Email:  SMALL@trials.bham.ac.uk