Investigator downloads

Click arrows below to expand and reveal tables containing downloadable documents relating to the trial. Current documents will be uploaded onto the website as and when they are updated.

Protocol

PROFILE ProtocolV5.020/10/2020Here
PROFILE ProtocolV4.212/06/2020Here
PROFILE ProtocolV4.212/06/2020Here
PROFILE ProtocolV4.109/04/2020Here
PROFILE ProtocolV4.029/11/2018Here
PROFILE ProtocolV3.030/04/2018Here

Guides and Manuals

File nameVer.DateDL
Trial ManualV2.010/07/2020Here
Trial ManualV1.027/11/2017Here
MRE ManualV1.027/11/2017Here
Colonoscopy ManualV2.013/02/2018Here
SES CD Scoring PosterV1.001/12/2017Here
Endoscopy Video Recording GuidanceV3.013/06/2018Here
CRF Completion GuideV2.009/07/2020Here
CRF Completion GuideV1.114/06/2018Here
SAE Reporting RequirementsV2.018/02/2018Here
AEs of InterestV1.009/02/2018Here
Laboratory ManualV1.027/11/2017Here
Laboratory Manual AppendicesV1.027/11/2017Here
Randomisation ManualV1.005/12/2017Here
Pharmacy ManualV4.009/07/2020Here
Pharmacy ManualV3.009/01/2019Here
Pharmacy ManualV2.011/01/2018Here

Meetings

File nameVer.DateDL
PROFILE Investigator Meeting 2018 ProgrammeV1.002/02/2018Here
PROFILE Investigator Meeting 2018 Trial Protocol and OutlineV1.009/03/2018Here
PROFILE Investigator Meeting 2018 Translation of Biomedical AdvancesV1.009/03/2018Here
PROFILE Investigator Meeting 2018 Recruitment Randomisation and TimelinesV1.009/03/2018Here
PROFILE Investigator Meeting 2018 Endoscopic Scoring and Mucosal HealingV1.009/03/2018Here
PROFILE Investigator Meeting 2018 CRF and Site ActivitiesV1.009/03/2018Here
PROFILE Investigator Meeting 2018 Biology of PROFILE MarkerV1.009/03/2018Here

Training

File nameVer.DateDL
SIV SlidesV4.101/07/2020Here
SIV SlidesV4.005/03/2019Here
SIV SlidesV3.304/09/2018Here
SIV SlidesV3.210/05/2018Here
Pharmacy SlidesV2.110/05/2018Here

Top Tips for Recruitment

File nameVer.DateDL
Clinician's Guide for Recruiting to PROFILEV1.026/02/2018Here

Page last updated: 10th May 2021