How does compliance with 21 CFR Part 11 help ensure data integrity and subject safety in clinical research
Electronic medical records and electronic handling of study data is increasingly common.
To involve computer systems in clinical research implies knowledge of 21 CFR Part 11(ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) and all of the ramifications of this Part of the code is essential. Basically electronic records and electronic signatures must be trustworthy, reliable and generally equivalent to paper records and signatures executed on paper. The differences between the traditional paper system and an electronic system is significant. One must know and follow the Part 11 code. System validation has many items to follow but none more important than the who, what, and when aspect of the Data / Audit Trail. These trails must be secure, operator independent, computer generated, date & time stamped, and (most importantly) available for the FDA reviewer. SOPs and staff training is often what separates the good from the not good systems. This presentation is for the non-computer literate clinical research staff.
Areas Covered in the Session:
- The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid?
- What needs to happen to make data trails secure and real
- What questions should you internal QA department ask to be sure your system is functioning correctly?
- What controls need to be in operation for an open system?
- What are the controls needed for a valid electronic signature?
- The Role of Standard Operating Procedures and staff training in a functional Electronic Data Capture system
- What are the suggested controls to ensure authenticity, integrity and confidentiality of your EDC system?
Who will Benefit: This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects.
Those benefiting the most would be:
- Principal Investigators and sub investigators
- Clinical Research Scientists (PKs, Biostatisticians, ...)
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting staff
- QA / QC auditors and staff
- Clinical Research Data managers