Process
Process
Steps
The following key steps are required to run a study. They do not need to occur in this order - as long as everything get completed before the Wizard can be run. (Click on each title to view the details).
CliniSafe Licence
It is the Licensee who is invoiced. Apply for a Licence from the Contact page. Create Project...
This allows collaboration on Project from any user. The person creating the Project becomes the Project Owner. Invite people onto the Project...
Anybody can be Invited onto the Project - usually from your own organisation - but could from an associated CRO, or consultant. See the Integrated Research Platform for more details. Certification and Accreditation...
CliniSafe will train users, by eLeaning, web based training and on-site training. Once your organisation has adequately trained - trainers, it can become Accredited so that it can do its own training. Map Drug Rules...
A SOP clearly explains the steps to go through to create a Drug Rule Map. Create Drug Rules...
A SOP clearly explains the steps to go through to create a Drug Rule Map. Create Drug Rules...
Follow the plan set out in the Map. Create Countries...
Drug Rules Version - Creating and Authorising...
Drug Rule Versions are Authorized to a Country. Translation...
CliniSafe has already translated the rest of the website. Create Research Sites / Investigators...
The Investigators will be emailed a link and they will progress through the eLearning before entering CliniSafe...
Run the Wizard. Enter the subject's drugs into the Wizard and view the results. If the Subjects module is being used - the subject's drugs are remembered for the next visit. Close down the Study...
Eventually all sites within a Country will be completed and the Country can be set to Completed. Eventually all countries will be completed and the Project can be set to Completed...