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.
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.