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EDC System User Roles in Clinical Data Management

Electronic Data Capture (EDC) system is a piece of web-based software used to collect, clean, process and transfer data in clinical trials data management. EDC usage has become a preferred method for real-time clinical data capture as it is more accurate, efficient and secure, requires less time and has a lower cost. 

Seeing as there are many different tasks to be carried out in clinical trial project management, team members must take on different roles. Thus, one of the crucial aspects of working with EDC is role-based functionality.  

Even though each User Role may have different functionality, there are still some universal guidelines applied to all User Roles: 

  • Each User Role must be clearly described in the system and, if necessary, in Data Management documents;  

  • Each User’s access to the EDC system must be compliant with Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11); 

  • In order to prevent unauthorized access to the EDC, there must be secure User authorization controls to identify the person accessing the system and submitting the data; 

  • Each User must have a unique login and a password that is changed regularly;  

  • 21 CFR Part 11 sets standards for using electronic signatures in clinical trials. Accordingly, signatures must include a printed name, the date and time of signature, as well as the reason for the signature (e.g., review, approval). To ensure compliance with 21 CFR Part 11signatories must have unique loginand passwords, meaning that to sign a document, the User should enter their own password and never sign documents using another user’s login; 

  • Each User of the EDC system must be trained how to use it, including details applicable to each specific role, before access to the system is granted, and all training results must be accurately documented. 

Here are examples of main User Roles that can be observein different EDC systems within clinical data management and clinical supply management: 

User Role 
 User Rights Description 
Principal Investigator/ Investigator
Data entry and approval from the study site’s side 
   Data Coordinator/ Site Coordinator  
Data entry from the study site’s side 
Monitor/ CRA 
 Data clarification and verification 
Project Manager 
 Data overview and formation of requests on supplies of IP  
Sponsor/ Study Coordinator 
 Data overview  
Data Manager 
 Data cleaning 
Data Management Assistant 
 Data cleaning 
Database Administrator 
 Administration of project-specific database 
 Work with supplies of IP on the storage side 
 Receipt of IP supplies from the study site’s side 


Depending on the clinical study design, in addition to the main User Roles, specific roles may also be required. The advantage of some EDC systems is the ability to configure such roles, which facilitates the clinical research and simultaneously reduces time and costsNoteworthy examples of these specific roles include unblinded ones (Unblinded Monitor/ Study Coordinator/ Pharmacist/Independent Evaluator).

OCT Clinical has extensive expertise in dealing with such requests and successfully provides these clinical trial servicesIn our Data MATRIX EDC/ IWRS, we can configure User Roles to have different access rights, functions, visibility of electronic CRFs and visits. Each additional User Role is carefully described in the project Data Management documentation and meets regulatory requirementswhich is confirmed by testing and validation according to the company’s Standard Operating Procedures. 

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