Study Documents

Feasibility:

•  FLO-ELA summary for sites v5.0.pdf (605 KB)

•  Feasibility Form v2.0.docx (160 KB)

•  Feasibility Form v2.0 (Scotland and N.I.).docx (164 KB)

Please send completed feasibility forms to: admin@floela.org

Training:

•  FLO-ELA Tailored GCP Training Slides v5.0 (1.18 MB)

•  FLO-ELA Training Requirements v2.0.pdf (652 KB)

Delivery:

•  SOP 001 - Management of the Intervention Group Patients v2.0.pdf (748 KB)

•  SOP 002 - Management of the Control Group Patients v2.0.pdf (331 KB)

Associate PI Scheme:

•  Associate Principle Investigator (PI) Scheme Summary V2.0.pdf (158 KB)

•  Associate PI checklist_5.0.docx (46 KB)

Posters:

•  FLO-ELA Poster 1.pptx (436 KB)

•  FLO-ELA Poster 2.pptx (254 KB)

Study Paperwork:

•  FLO-ELA Protocol v4.0 27-04-22 CLEAN (1.04 MB)

•  PIS (England & Wales) V6.0.docx (145 KB)

•  Consent Form (England and Wales) V4.0.docx (49 KB)

•  PIS (Northern Ireland) V2.0.docx (143 KB)

•  Consent Form (Northern Ireland) V1.0.docx (49 KB)

•  PIS (Scotland) V4.0 (142 KB)

•  Consent Form (Scotland) V3.0 (49 KB)

Note to trial participants: the study paperwork is "localised" at each participating hospital. The contact details of your local research team can be found in the paper version of the information sheet that you are given during enrolment to the trial.

Trial Oversight Committee Charters:

•  FLO-ELA DMEC Charter v2.0 CLEAN.pdf (327 KB)

•  FLO-ELA TSC Charter V2.0 CLEAN.pdf (327 KB)

Statistical Analysis Plan:

•  FLO-ELA SAP v4.0.pdf (694 KB)