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

Either the CRO or the Sponsor needs a CliniSafe Licence.
It is the Licensee who is invoiced.
Apply for a Licence from the Contact page.

Create Project

The Project can be created within any Licence – by anybody – as long as they know the secret Project Create PIN.
This allows collaboration on Project from any user.
The person creating the Project becomes the Project Owner.

Invite people onto the Project

CliniSafe uses the “By Invitation” security model.
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

Each user of the Integrated Research Platform must be trained, and Certified, on the various dashboards they use.
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

Mapping the Drug Rules using a Word document is a precursor to creating the Drug Rules in the next step.
A SOP clearly explains the steps to go through to create a Drug Rule Map.

Create Drug Rules

Once there is a Drug Rule Map, creating the Drug Rules is quick and easy.
Follow the plan set out in the Map.

Create Countries

Create the Countries and define the languages that the study is going to run in.

Drug Rules Version – Creating and Authorising

Drug Rules are created within a Drug Rules Version.
Drug Rule Versions are Authorized to a Country.

Translation

The drug rule messages needs translating into the languages of the trial.
CliniSafe has already translated the rest of the website.

Create Research Sites / Investigators

Create the Research Sites and the Investigators at those sites,
The Investigators will be emailed a link and they will progress through the eLearning before entering CliniSafe.

Research Sites need to have their Ethics Approval before they can go live.

Run the Wizard

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, a Research Site will complete all of its subjects – and that site can be set to Completed.
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.