TTM2-TAME Trial

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What happens when you ask for a change to Spinnaker

2018-02-16
So you have found something in your study that needs to change. Heres a small insight into what we do when you ask for a change.
It could be that something in your CRF has changed, you have found a better way to do something or maybe something in Spinnaker is annoying you. Whatever it is, the path is the same and for the purpose of this example lets assume it’s a reasonable request and the change will be applied.
The change may begin with a Research Coordinator in a hospital who contacts the Project Manager with a suggested change.
The Project Manager passes reasonable requests on to us here at Spiral where the change goes through 3 phases …  development, staging/testing, and production. We have an environment for each of these.

Development
New requests for changes are scheduled and assigned to one of our developers. They make their changes and create a new version of Spinnaker for your project. They test the changes work before the next phase …

Staging
Once the changes have been made one of our team checks and tests a few things around the change including testing that:
  • the changes made match the request
  • the new functionality actually works
  • Spinnaker is stable and continues to work as expected
Every project has a staging site which has a combination of the latest Spinnaker code on it and a copy of your study database. We have a whole server dedicated to our staging sites. If anything goes wrong here it’s not going to affect your study!
Then onto the next phase…
Production
When testing on the staging site is completed we schedule a release date. We time the release for a quiet time of day when there are few or no people signed in to your study. During the release we:
  • check there is no-one adding or editing a form
  • compare the database structure between the production and staging environments
  • copy any database changes to the production environment. Only the database structure is copied, not any data.
  • copy the new code to the production environment
  • check Spinnaker is stable
  • tell your project manager about the release
That’s it in a nutshell …. except of course we keep doing this in a continuous cycle because that’s Devops and Agile development!

 
 

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About the TTM2 Study

The TTM2 trial is a phase III, multi-centre, randomized, parallel-group, clinical trial in resuscitated cardiac arrest patients admitted to the intensive care unit to investigate whether targeted temperature management (TTM) to 33°C improves survival and neurological outcome at 6 months compared to a strategy of targeting normothermia and avoiding fever above 37.7°C. More information »

About the TAME Study

The TAME trial is a phase III, multi-centre, randomised, parallel-group, clinical trial in resuscitated cardiac arrest patients admitted to the intensive care unit to determine whether targeted therapeutic mild hypercapnia (TTMH) improves neurological outcome at 6 months compared to standard care (targeted normocapnia) (TN). More information »

About the software

Spinnaker is a tailored, web based, software and database solution for managing your multi-centre clinical study including the recording of patient data, recording and alerting of events, inventory management and reporting on data collected during the course of your study. Spinnaker is user friendly, adaptable and can be delivered quickly. You can read more on the Spinnaker website or contact Audrey on spinnaker@spiral.co.nz.

 

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