There is no doubting the fact that electronic data capture systems (EDC) have completely transformed the way clinicians conduct medical research. These software and systems have enabled researchers to swiftly collect, process, and analyze data, speeding up the entire trial, which leads to effective medicinal and therapeutic development.
Having said that, many stakeholders are involved when conducting a clinical trial. From clinicians and CROs to sponsors and relevant regulatory bodies, everyone keeps a close eye on the trial proceedings and tries their best to make it successful. As a clinician or someone planning to conduct medical research, you should know the major stakeholders in a clinical trial. Let’s discuss the primary and other users of electronic data capture systems.
Clinical data EDC systems User Groups
We can classify the users of an EDC system into three groups: primary, secondary, and super users. In order to access the system, primary and super users are required to create user accounts with their credentials. This step is particularly important because it helps track the usage of every individual, which helps in accountability.
Primary users are those directly involved in the trials, such as clinicians, medical researchers, data entry personnel, scientists, study coordinators, coinvestigators, co-principal investigators, and principal investigators. Project owners are also primary users who oversee the entire project.
Super users are backend users responsible for the system’s administration. The super users have two roles: honest broker and system administrator. While the honest broker handles the data requests from several research teams, the system administrator manages the RDR and EDC systems. An honest broker is a person who gathers and offers PHI data to research investigators in an IRB-approved manner.
Secondary Users of Clinical data EDC systems
Another group of users that is also important in any clinical trial is the second group. The secondary users are study participants, comprising survey participants and study subjects. Participants use the eCRF and ePRO systems, which are a part of the entire EDC and clinical trial.
The entry personnel enters any study subjects’ data into the research database. Laboratory results can be imported electronically from the EMR (Electronic Medical Record) system or entered into the research database by data entry personnel. If a project has survey instruments, participants may record their responses via public or personalized URLs.
How Can ClinicalPURSUIT Help?
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We have made a name for ourselves by providing the best EDC software for clinical trials to elevate your clinical trial setting and help you achieve impactful results. We also provide Randomization and Drug Supply Management and Electronic Patient-Reported Outcome Software. Schedule a one-on-one free demo today!
