Click below to download study documents
Study Protocols
Study Protocol in English (version 2.0)
Study Protocol in Portuguese (version 1.0)
Study Protocol Signature sheet in English (version 2.0)
Patient Information
OPTIMISE II UK Patient Information Sheet (version 4.1)
OPTIMISE II UK Patient Information Sheet for Scotland Only (version 5.1)
OPTIMISE II International Patient Information Sheet in English (version 3.0)
OPTIMISE II International Patient Information Sheet in German (version 3.0)
OPTIMISE II International Patient Information Sheet in Spanish (version 3.0)
OPTIMISE II International Patient Information Sheet in Arabic (version 3.0)
OPTIMISE II International Patient Information Sheet in Polish (version 3.0)
OPTIMISE II International Patient Information Sheet in Romanian (version 3.0)
OPTIMISE II International Patient Information Sheet in Portuguese (version 3.0)
Study Forms
Study CRF UK version (version 7.0)
Study CRF International version in English (version 6.0)
Consent form for use in Scotland Only (version 4.0)
Consent form International in English (version 2.0)
OPTIMISE II Consent Form International in German (version 2.0)
OPTIMISE II Consent Form International in Spanish (version 2.0)
OPTIMISE II Consent Form International in Arabic (version 2.0)
OPTIMISE II Consent Form International in Polish (version 2.0)
OPTIMISE II Consent Form International in Romanian (version 2.0)
OPTIMISE II Consent Form International in Portuguese (version 2.0)
Study Logs
OPTIMISE II Delegation log (version 1.0)
OPTIMISE II Screening log (version 3.0)
OPTIMISE II Screening log - for use in Canada only (version 3.0)
OPTIMISE II Enrolment log (version 1.0)
OPTIMISE II Version control log for the UK (version 1.0)
OPTIMISE II Version control log for use outside the UK (version 1.0)
HRA approvals
Initial favourable opinion letter from REC
Recommendations and Sponsorship
QMUL Declaration of Sponsorship
QMUL Verification of Insurance (2016/2017)
QMUL Verification of Insurance (2017/2018)
QMUL Verification of Insurance (2018/2019)
QMUL Verification of Insurance (2019/2020)
QMUL Verification of Insurance (2020/2021)
Standard Operating Procedures
SOP for patient screening and informed consent procedures (version 1.0)
SOP for managing the intervention group patients (version 1.0)
SOP for managing the control group patients (version 1.0)
SOP for patient infection follow-up (version 1.0)
SOP for safety reporting (version 1.0)
SOP for database user guide (version 1.0)
SOP for cancelled or delayed surgery post-randomisation (version 1.0)
Publication Charter SOP (version 1.0)
Statistical Analysis Plan (version 2.0)
Statistical Analysis Plan (version 3.0)
Site Initiation Visit checklists
SIV general checklist (version 2.0)
SIV individual training checklist (version 2.0)
OPTIMISE II UK investigator site file index (version 5.0)
OPTIMISE II International investigator site file index (version 2.0)
OPTIMISE II Canadian investigator site file index (version 5.0)
OPTIMISE II Contact List (version 4.0)
Study Slideset
OPTIMISE II Slides (version 1.0)
Site feasibility questionnaire
Site feasibility questionnaire (version 1.0)