Click below to download study documents

Study Protocols

Study Protocol in English (version 1.0)

Study Protocol Signature sheet in English (version 1.0)

Patient Information

OPTIMISE II UK Patient Information Sheet (version 2.0)

OPTIMISE II International Patient Information Sheet in English (version 2.0)

OPTIMISE II International Patient Information Sheet in German (version 2.0)

OPTIMISE II International Patient Information Sheet in Spanish (version 2.0)

OPTIMISE II International Patient Information Sheet in Arabic (version 2.0)

OPTIMISE II International Patient Information Sheet in Polish (version 2.0)

OPTIMISE II International Patient Information Sheet in Romanian (version 2.0)

GP Letter UK (version 1.0)

Study Forms

Study CRF UK version (version 6.0)

Study CRF International version in English (version 5.0)

Consent form UK (version 2.0)

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)

Study Logs

OPTIMISE II Delegation log (version 1.0)

OPTIMISE II Screening log (version 1.0)

OPTIMISE II Enrolment log (version 1.0)

OPTIMISE II Version control log (version 1.0)

HRA approvals

HRA Approval Letter

HRA Initial Assessment Letter

HRA Statement of Activities

HRA Schedule of Events

Initial favourable opinion letter from REC

REC validation letter

IRAS form (December 2016)

Recommendations and Sponsorship

QMUL Declaration of Sponsorship

QMUL Verification of Insurance (2016/2017)

QMUL Verification of Insurance (2017/2018)

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)

Publication Charter SOP (version 1.0)

Site Initiation Visit checklists

SIV general checklist (version 0.1)

SIV individual training checklist (version 0.1)

OPTIMISE II UK investigator site file index (version 2.0)

Study Slideset

OPTIMISE II Slides (version 1.0)

Site feasibility questionnaire

Site feasibility questionnaire (version 1.0)

Monitoring plan

OPTIMISE II monitoring plan (version 1.0)

OPTIMISE II monitoring plan (version 2.0)