Being compliant with clinical trial rules and regulations is not always at the top of the list of researchers and investigators, or of the organization to which they belong. When researchers are involved in industry sponsored studies, compliance is taken care of by the sponsor or the contract research organization that runs the study. But in the case of investigator initiated trials, the researchers often struggle with ensuring a sufficient level of compliance.
The good news is that our clinical data management and EDC solution Promasys®, which is developed over more than 25 years on the work-floor of clinical trials in close interaction with researchers and trial professionals, that Promasys helps its users and their organization to be compliant with GCP, with FDA 21 CFR Part 11, and with HIPAA and similar privacy regulations. Many components of Promasys, such as the robust yet flexible access control system, in combination with Promasys’ unique quality model the Study Life Cycle®, with the audit trail that works throughout the system, and the electronic signature functionality, all work together to take away the burden of worrying about compliance from the individual users. Let’s take a closer look at these important components of the system.
First, there is the Set&Forget access control system, which allows you to setup the access rights in a very granular way, and this is typically something that we help our users with during the initial configuration and implementation of the system. Once set up properly, you no longer need to worry about the required access level of the users to the clinical trial data and patient information. That is because the access control systems works together with Promasys’ unique quality model, the Study Life Cycle.
We also call the Study Life Cycle our Quality and Compliance Engine. The Study Life Cycle divides a trial in a number of well-defined phases, or stages. Moving a study from one phase to the next is centrally controlled, in a module that can be only access by users with the appropriate access level. The phases of the Study Life Cycle follow the normal flow of a study. And the required access levels are automatically adjusted to the particular phase a study is in. It starts with the Definition phase, then go through the Approval phase, the Execution phase, the Data Completion phase, to the Analysis phase, the Finalization phase and finally the End phase.
Now, what is relevant for the topic of automatic adjustment of the required access level to the phase of the Study Life Cycle that a trial is in: the user who based on his access rights in the DEFinition phase could define the data items and the visit schedules etc. in the Execution phase no longer can make any changes to the design of the study. No need to change the role of this user in Promasys, it automatically adjusts to the Study Life Cycle phase.
Promasys’ access control system together with the automatic working of the Study Life Cycle ensure that certain actions can only be performed by users with the correct access rights. This is extremely important functionality that protects the integrity of the data. But there is another important component of data integrity and that is the audit trial, that tracks the exact history of each individual data item.
Promasys’ system generated audit trail records for each data item when a value was entered, date and time, and who entered the value, which user. But it also shows for each data item when it was created during the study build process, and by whom, and of course also for any changes to the design of the data item that were made later on. And Promasys does not only track the history of the data items, it does this -technically speaking- for each record in the database, that is, you can see the history of each subject or patient, and of each visit. And also you look at the audit trail on the study or protocol level, and for instance see which user at what date and time moved the study from one Study Life Cycle phase to another. Check out the webinar for more information!