Sign the data sharing agreement
Obtain local approval for the study
Written confirmation of local approval should be acquired as a necessary document for participation to GNOS Spine. Each institution should follow their local protocols to obtain this.
We anticipate that this study will be considered by most institutions worldwide as service evaluation and as such will not require formal review by an ethics committee. However, some institutions may consider this project original research, in which case we would recommend following local protocol to gain approval.
We will give you access to our secure, online data platform, ORION
Confirm the details of your study team, and we will give you access to our secure, online study platform, ORION. All further processes of the study will be completed on this platform.
The data validator will be given access to a separate platform to ensure that they remain blinded from the local study team's data.
Create a local study team
Each study team should consist of a local study lead, upto 2 additional local study team members, and an independent data validator.
Register your institution to join GNOS Spine
Fill in the registration form below with your team and your institution's details to register your interest in becoming collaborators for this study. You will be contacted by the central study team with next steps once you have done this.
Upon accessing Orion for the first time, the local study lead will be asked to complete and sign a Data Sharing Agreement form before proceeding.
Complete a Site Questionnaire for your institution
The study lead will be asked to complete a site questionnaire for their institution. This does not need to be completed in one go, and can be saved as a draft before submitting, as we recommend consulting your colleagues where necessary to ensure that the information provided is accurate.
Select a 30-day data collection period for your institution
Any 30-day study inclusion period can be selected starting from July 12th 2021 until 2022. Please ensure you select a period where all of your local team will be working in the department and not on leave. Please note that the study inclusion period will be 4 weeks, and outcomes will be collected up to 6 weeks after the final patient is included.