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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:
Here are examples of main User Roles that can be observed in different EDC systems within clinical data management and clinical supply management:
User Role |
User Rights Description |
|
Principal Investigator/ Investigator
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Data entry and approval from the study site’s side
|
|
Data Coordinator/ Site Coordinator
|
Data entry from the study site’s side
|
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Monitor/ CRA
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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
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Administration of project-specific database
|
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Logistician
|
Work with supplies of IP on the storage side
|
|
Pharmacist
|
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 costs. Noteworthy 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 services. In 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 requirements, which is confirmed by testing and validation according to the company’s Standard Operating Procedures.
OCT Clinical is now operating under Palleos Healthcare brand name.
“The merger will undoubtedly create significant synergies, not just doubling but squaring the expertise of both companies”, Philip Räth, Ph.D., managing director at Palleos, said in the release.
“OCT Clinical is proud to join forces with palleos healthcare, as it has an excellent reputation in the industry it serves. Now we can offer tailored solutions to our clients to meet their diverse clinical research needs and accelerate the time of bringing their products to market”, Dmitry Sharov, CEO at OCT Clinical.
