Professional Documents
Culture Documents
Intro To OpenClinica
Intro To OpenClinica
Diary
CRF
DCF
Investigator Monitor
Sample Statistician
CRF DCF NDA
Lab Clinical
Results Data
Regulatory
Authority
Involved Data Manager Clinician
Laboratories
What is CDMS?
• A clinical data management system or CDMS
is used in clinical research to manage the data
of a clinical trial
• It is set up to help with processing data from
source through validation checks, analysis,
reporting and storage;
• Also useful for Coding (particularly for AEs and
Medications)
– MEDRA (Medical Dictionary for Regulatory Activities)
– WHOART (WHO Adverse Reactions Terminology)
Institutional Approach
• Setting up a specific CDMS requires institutional
decision making at policy level
• Whatever the choice, it comes with a cost
• Requires infrastructure and equipment set up
• Requires minimum core competencies
• Dedicated time for learning and development
• Opportunities to try out
Preferred Software characteristics
• Standards based
• Well known many skilled practitioners available
• Readily mastered and modified
• Should run on any platform
• Should be affordable for small groups in resource
constrained countries
Why an open source approach?
• Potential advantages of Open Source solution
– Cheaper
– More amenable to change
– No vendor lock in
– More able to be integrated with other systems
– Likely to be well documented
– Designed to be multilingual
– Open source software works eg R, Apache, MySQL
– Used by major IT players eg Google, HP & IBM
– Has been argued provides better software
• saved the Human Genome Project according to Lincoln Stein
Introducing OpenClinica
Free, open source, web-based software for EDC built by
Akaza Research
Features:
– Management of diverse clinical studies through a unified interface
– Clinical data entry and validation
– Data extraction
– Study oversight, auditing, and reporting
Creating Data Bases in OpenClinica
Designing a database in OC; requirement and flow of data.
Submit data Module; Web-
based Data entry and validation
OC - DataBase
• Interfaces for data query and retrieval across subjects, time, and clinical
parameters
• Compliance with regulatory guidelines e.g. 21 CFR Part 11
• Built on robust and scalable technology infrastructure interoperable with
relational databases
Designing CRFs
Done in excel using a blank CRF template
provided by Openclinica
Uploading CRFs
The excel sheet is then uploaded onto OpenClinica
Event Definition
Data Entry
Data Extraction
System End of OpenClinica
The Back Up Setting
NAS1
Database Database
server