FAQ

What is SEPTRE?

SEPTRE (SPIRIT Electronic Protocol Tool and Resource) is an innovative, web-based software solution that makes it easier to create, manage, and register high-quality protocols for clinical trials.

Why should I use SEPTRE?

The traditional manual process of using a Word template to write and format a protocol, and then copying and pasting various sections into a trial registry, is error-prone and inefficient. SEPTRE has unique technological features that save time while promoting quality and transparency. First, each field in SEPTRE is based on the widely endorsed SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidance for developing high-quality protocols. SPIRIT-based protocols will be easier for research ethics boards and journals to review. Second, SEPTRE saves time and promotes transparency by enabling users to seamlessly register their protocol on ClinicalTrials.gov, track amendments, and generate a formatted Word document.

Who developed SEPTRE?

SEPTRE was conceptualized and developed by a team at Women’s College Hospital, University of Toronto, led by Professor An-Wen Chan (SPIRIT Chair). Development was funded by the Canadian Institutes of Health Research, Ontario Centres of Excellence, and Ontario Ministry of Health and Long-term Care Innovation Fund.

How much does it cost to use?

SEPTRE is available by institutional or individual user subscription. Please contact us to enquire further or request a free trial.

Who do I contact if I have more questions?

Please submit your questions or comments here or email septre@spirit-statement.org