FDA Guidance Regarding Software Validation for Clinical Trial Management Systems
Overview:
Clinical trial management systems are not medical devices yet the software used to collect clinical trial information should be validated and some have suggested the software validation steps used for medical device development may be appropriate.
This talk will review two current FDA guidance documents on this topic including "Computerized Systems Used in Clinical Investigations" which is clearly applicable to CTMS and "General Principles of Software Validation" which is more directly applicable to software within a medical device. Key features of a good CTMS software validation process will be presented and a review of the required Quality Management System Standard Operating System documents will be provided.
Why should you attend: The available FDA guidance documents do not clearly describe how to validate clinical trial management systems (CTMS). CTMS developers, users at sites and vendor/site auditors are left to interpret the clinical trial regulations and FDA guidance documents. Two guidance documents will be reviewed in this webinar: "Computerized Systems Used in Clinical Investigations" which is clearly applicable to CTMS and "General Principles of Software Validation" which is more directly applicable to software within a medical device; however, many auditors point to this guidance and may attempt to require rigorous software validation principals which may not be the "least burdensome" path for CTMS development.
Areas Covered in the Session:
- Key 'software validation' approaches related to CTMS will be presented
- The FDA guidance for industry "Computerized systems used in Clinical Investigations" will be discussed in detail
- Details appplicable to CTMS development will be detailed as described in the FDA guidance “General Principles of Software Validation”
- Key CTMS software validation steps will be discussed
Who Will Benefit:
- Presidents and CEOs of CTMS providers
- CTMS developers, testers auditors
- Site Managers responsible for CTMS selection
- Directors of Clinical and Regulatory Affairs
- Managers of Quality Affairs
- Clinical Research Coordinators & Associates
- Clinical Project Managers, Research Nurses, Scientists and Others