One of the most important aspects of the clinical trial process is making sure that the right people have the right access to view and edit study data. One could argue that the success or failure of a drug trial hinges on the proper assignation of permissions to each team member. Permissions are the barriers that prevent important data from falling into the wrong hands or, equally as problematic, not being received by the right hands. The key to managing the user permissions for your trial is understanding what the basic user permissions are. From there you can customize them depending upon the needs of your unique trial, with help from your EDC provider.
The first and most important thing to note before you begin assigning permissions is that one, and only one, member from your team should be assigned to manage all user permissions. This is typically the job of your Project Manager (PM), and it is important for that person to be trained on permissions, in general, and your team’s needs, specifically. Your Prelude PM can help you set up the initial users if you are unsure where to start, and they can offer guidance and support throughout the life of the trial. It is up to you and your team, however, to ensure that you have the necessary users set up with the proper permissions before your trial begins. There is no one set process for determining your user permissions, but it is important that no more than one person should have the ultimate power to edit and manage the users and permissions in the system. This measure is in place to prevent conflicting user assignments or improper access to data being given to users. Having a streamlined process for managing user permissions is a vital pillar of Good Clinical Practice (GCP). It also mitigates confusion and promotes communication.
The second thing to note is that the earlier you get your users and permissions set up, the better. The farther into a study you get, the more complicated and potentially problematic it becomes to change the permissions. For example, if you determine that the Investigator should not have been able to view the treatment assignments of their patients halfway through the study, your results from the first half of the study might be deemed unusable. That would be bad!
Finally, do not rely on your EDC provider to know what permissions you need for your trial. It’s your study and your neck on the FDA chopping block! This is where proper training comes in. Here are four basic user-access categories to keep in mind when setting up and managing your user permissions and remember: your Prelude team is here to help and guide you should you need further customizations.
1. Prelude personnel
This includes your Prelude PM and Prelude Quality Assurance (QA) team. The PM will have Administrator access-only to your Live study so that they can assist you with user access issues and mid-study updates. QA will also be able view all study forms so they can ensure they meet industry standards. Neither of these roles will be given data-entry access to patient forms.
2. Non data-entry personnel – This category includes two sub-categories, both of which are given view-only access to patient forms:
- Roles which can view and edit all user/site/project forms, e.g., Project Manager, Monitor.
- Roles which have limited access to view and edit user/site/project forms, e.g., Coordinator, Medical Monitor.
3. Data-entry personnel – This category includes two sub-categories:
- Roles which can view and edit all patient data, e.g., Investigator
- Roles which have limited access to view and edit patient data, e.g., Patient, Lab Technician.
4. View-only personnel
These are the roles which, like Prelude personnel, cannot edit any data and can only view the forms which are necessary for them to view (again, as determined by you and your team), e.g., Sponsor, Statistician, Data Manager.
Of course, there will always be exceptions to these basic permissions. Perhaps your Medical Monitor should be able to enter patient data, or your Lab Technicians shouldn’t be able to view site data. You can also, of course, add or remove roles according to your every whim (well, maybe not every whim, but we’ll do our best). This is the beauty of using a highly customizable system like the one provided by Prelude. The possibilities are endless! Whatever your study needs, Prelude delivers. Our system is designed to make your study run as efficiently as possible by catering to your unique needs. Customize away!