Click below to download study documents

Study Protocols

Study Protocol in English (version 1.6)

Study Protocol Signature sheet in English (version 1.6)

Study Forms

Study CRF for the UK (version 1.4)

Study CRF for Italy (version 1.4)

Study CRF for Norway (version 1.4)

Study CRF for Sweden (version 1.4)

Study CRF for Spain (version 1.4)

Study CRF for South Africa (version 1.4)

Consent Form in English (version 1.2)

Consent Form in Spanish (version 1.3)

Standard Operating Procedures

Study Adverse Event SOP in English (version 1.1)

Protocol Deviation SOP in English (version 1.1)

CPAP SOP in English (version 1.2)

Monitoring SOP in English (version 1.3)

Investigator Site File Checklist (version 0.1)

Authorship TSP (version 2.0)

PRISM definitions appendix (version 1.6)

Studies approved for co-enrollment with PRISM (version 1.3)

Study Logs

PRISM Screening log (version 1.0)

PRISM Delegation log (version 1.0)

PRISM Enrolment log (version 1.0)

Version control log (version 1.0)

Patient information

Patient Information Sheet (version 1.1)

Patient Information Leaflet (version 1.0)

Patient Information Sheet in Spanish (version 1.2)

GP Letter (version 1.0)

Recommendations and Sponsorship

QMUL Declaration of Sponsorship

Initial favourable opinion letter from REC

REC covering letter (August 2015)

REC covering letter (April 2016)

Acknowledgement of receipt of documentation by the REC following favourable opinion

Final signed R&D form

QMUL verification of insurance (2016-2017)

Monitoring visit documents

Monitoring Visit Action Checklist (version 1.0)

Consent and Eligibility Checklist (version 1.0)

Monitoring Report (version 1.0)

SDV Checklist (version 1.0)

Site Visit Log (version 1.0)

Site File Checklist (version 1.1)