Users roles is one of the special feature in Oracle Clinical RDC in which each and every user have some specific permissions. Just for the data protections or quality, one user can use some feature not all. Each user role defines what you can do and what cannot do in the RDC onsite.
By default, RDC Onsite has some pre-defined user roles:
- Site user
- Clinical Research Associate (CRA)
- Data manager
Sponsor or as per sponsor instructions RDC Onsite Admin can create and define various other user roles. You can create large number of users there is no limit of user define and modify or can be deleted anytime by admin.
The following sections describe the default user roles.
Site user or Site coordinator, who enters data from trial sites and converts paper to electronic CRFs. After development of database design, site user is informed by data management team and then site user starts data entry from trial sites. Data entry and system-generated discrepancies run takes place simultaneously. Persons who perform this task included study coordinators, site nurse, research assistants, site coordinators and data entry personnel.
The Investigator is a physician or senior doctor responsible for particular study of that particular site. Site users enter all the CRFs data and send it to investigator for approval. Site data entered, reviewed and all discrepancies are resolved, then investigator electronically signs the forms and send it for analysis and data lock.
Clinical Research Associate (CRA)
Clinical Research Associate play as Important role in Clinical Trials because it act as a monitor who reviews data, find out the issues and performing source data verification remotely or during site visits on regular basis. Clinical Research Associate is an employee of sponsor or the Clinical Research Organization (CRO).
Patient data is entered, reviewed and all discrepancies resolved by the site coordinator then CRA has the privileges to verify all data electronically and finally confirm that all data has been reviewed.
Data Manager is a member of study team and work for sponsor and he/she is involved in regular meeting, discussion and reporting to sponsor regarding data collection and data status of whole study. Data Manager access RDC onsite to monitor enrollment status, track study progress, review the data quality and patterns as per study protocol. Data manager has a privilege to enter, review and resolve discrepancies.