Reference the steps below for the various functions of TrialKit. First, here's a brief overview of what TrialKit is:
TrialKit is a clinical research platform on any Android or iOS devices that make it simple for anyone to build, configure, and conduct a clinical trial in a powerful environment that complies with federal code guidelines (21 CFR Part 11). Sponsors can build and validate. Study Managers can deploy and manage sites, users, and patients. Monitors can review and lock data. Sponsors can get progress updates and various reports. Medical coders can perform WHO and MedDRA coding. Even patients themselves can access surveys or forms that need to be completed.
Ultimately, the functionality you have access to within the app depends on the studies you belong to and the role you serve in each of those studies.
This overview outlines every step to create your own clinical trial database using an iPhone or iPad and the remainder of the study lifecycle of data collection and review. Depending on your role in a study, it may be necessary to skip to the step(s) that apply to you.
Select the links below to read more about each step.
- Download the TrialKit app on IOS device from the Apple Store or on Android device from Google Play.
- Register for your own account
- Log In after receiving an email with your login credentials (if you don't see it, be sure to check your spam folder as well).
- Create a study
- Build the study forms
- Define log forms - These are forms that can be collected at any time, such as adverse events or protocol deviations.
- Design the visit schedule - Including Apple's ResearchKit tests
- Define unscheduled visits
- Set up user roles and permissions
- Test your study
- Add Sites and Users
- Publish the study for data collection
- Sites enter data
- Track study progress
- Manage queries
- Review data
- View various reports
Other factors of a clinical trial to consider and review:
- Functionality settings
- Study Workflow - monitoring and reviewing patient data
- Randomization (currently available through Clinical Studio on the web, and coming soon to TrialKit)
Need help or have something to report? It's simple to do directly in the app and we would love to hear!