STOMP: For Investigators

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 STOMP Trial Office.

• Site Staff Registration Form [.pdf]
• Investigator Registration Form [.pdf]
• Cenduit User ID Request Form [.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 STOMP Trial Office.

• Protocol [.pdf]
• Protocol Signature Page [.pdf]
• Trial Summary [.pdf]
• Patient Information Sheet  [.pdf]
• Informed Consent Form [.pdf]
• Patient Information Sheet Addendum 1.0 to PIS V5.0 [.pdf]
• Patient Information Sheet Addendum A to PIS V7.0 [.pdf]
• GP Letter [.pdf]
• Olaparib Investigator's Brochure [.pdf]

Version Control Lists

The version numbers and dates of all documents currently used for the trial are captured on a document version control lists below:

• ISF Main Documents Version Control List [.pdf]
• Pharmacy Version Control List[.pdf]

Amendments

Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• Substantial Amendment 1 13-Mar-2013 [opens a new page]
• Substantial Amendment 2 02-Oct-2013 [opens a new page]
• Substantial Amendment 3 29-Aug-2014 [opens a new page]
• Substantial Amendment 4 19-Jan-2015 [opens a new page]
• Substantial Amendment 5 27-Apr-2015 [opens a new page]
• Substantial Amendment 6 25-Aug-2015[opens a new page]
• Substantial Amendment 7 20-Jan-2016 [opens a new page]
• Substantial Amendment 8 08-Jul-2016 [opens a new page]
• Substantial Amendment 10 06-Apr-2017 [opens a new page]
• Substantial Amendment 13 14-May-2019  [opens a new page]

Case Report Form

Links to the current CRF are provided below. 

• Adverse Event Monitoring [.pdf]
• Baseline Form Version [.pdf]
• Concomitant Medication Log [.pdf]
• Conformation of Unblinding [.pdf]
• Death Form [.pdf]
• Deviation Form [.pdf]
• Eligibilty Checklist [.pdf]
• Follow Up Form [.pdf]
• New Primary Cancer Form [.pdf]
• Quality of Life Compliance and UK (English) EQ-5D-3L Booklet [.pdf]
• Randomisation Form [.pdf]
• SAE Fax Cover Sheet [.pdf]
• SAE Form [.pdf]
• Treatment Discontinuation Form [.pdf]
• Treatment Form [.pdf]
• Tumour Response Form [.pdf]
• Withdrawal Form [.pdf]

Guidelines

• SAE Form Completion Guidelines [.pdf]

Other Trial Documents

• CTCAE Quick Reference [.pdf]
• ECOG Performance Status Scale [.pdf]
• Release of Medical Information [.pdf]
• Revise RECIST Guidelines [.pdf]
• Patient Card [.pdf]
• Patient Diary BD [.pdf]
• Patient Diary TDS [.pdf]
• Site Signature and Delegation Log [.pdf]
• Investigator and Pharmacy Cenduit User Guide [.pdf]
• Patient Identification Log [.pdf]
• Patient Screening and Enrolment Log [.pdf]
• Site Instructions for Unblinding [.pdf]
• Out of Hours Emergency Unblinding Site Contact Details Form [.pdf]
• Insurance Certificate [.pdf]
• Pharmacy
  • 100mg Patient Drug Accountability Log [.pdf]
  • 150mg Patient Drug Accountability Log [.pdf]
  • IMP Labelling Guidelines [.pdf]
  • Pharmacy Manual [.pdf]
  • Prescription Form [.pdf]
  • Temperature Deviation Form [.pdf]
• Translational Sub Study Documents
  • Sheffield Sample Log [.pdf]
  • Freezer Strage Box Labels [.pdf]
  • Manchester CTC Sample Log [.pdf]
  • Translational Study Labels [.pdf]
  • University of Manchester Address Labels [.pdf]
  • Translational Study Guidelines [.pdf]
  • Translational Sub-study Blood Sample Form [.pdf]
  • Tissue Block Registration Form [.pdf]

Previous documentation

Links to superseded documentation are provided below.

• Protocol [opens a new page]
• Patient documents [opens a new page]
• CRF [opens a new page]
• Translational Sub-study [opens a new page]
• Investigator's Brochures [opens a new page]

• World Conference for Lung Cancer 2016 Abstract [.pdf]
• World Conference for Lung Cancer 2016 Poster Presentation [.pdf]

There is no current news or events for this trial.

Chief Investigator
Professor Penella Woll                                               
University of Sheffield                                                
Weston Park Hospital
Whitham Road                                                            
Sheffield
S10 2SJ                                                       

Tel: 0114 226 5235
Fax: 0114 226 5364                                                    

Email: p.j.woll@shef.ac.uk                                                       

STOMP Trial Office

Senior Trial Coordinator:                               TBC
Trial Coordinator:                                            Rebecca Parke
Trial Administrator:                                        Jessica Crook
Trial Monitor:                                                   Karen James

 

Trial Management Team Leader:                 Sarah Bowden
Trial Statistician:                                              Piers Gaunt

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

Enquiries
Telphone: +44 (0) 121 415 8544  
Fax: +44 (0) 121 414 2230
Email: STOMP@trials.bham.ac.uk

Serious Adverse Event Reporting
Fax: 0121 414 2230    or    0121 414 3700

Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
D Floor
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF

Tel: 0114 2265941
Fax: 0114 2265937
Email: Dipak.Patel@sth.nhs.uk