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Subscribe NewsletterThe Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors look for
Product Id
:
600028
Overview: All Clinical Research protocols have the procedures and processes needed to collect the data as it happens.
The FDA guidelines and regulations for the conduct of research involving human subjects were developed to ensure complete and credible data and, of course, to safeguard the health and safety of human subjects. This is further emphasized in the ICH E6Â 2.10: "All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification", which will allow the creation of a clear and followable data trail. The rules of collecting, correcting, and caring for all original (source) documents must be known by the entire study staff under the direction of the PI. In the end, the entire investigation team is charged with ensuring that the data obtained from trial subjects is accurate and valid. The presentation lays this on the table.
The FDA guidelines and regulations for the conduct of research involving human subjects were developed to ensure complete and credible data and, of course, to safeguard the health and safety of human subjects. This is further emphasized in the ICH E6Â 2.10: "All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification", which will allow the creation of a clear and followable data trail. The rules of collecting, correcting, and caring for all original (source) documents must be known by the entire study staff under the direction of the PI. In the end, the entire investigation team is charged with ensuring that the data obtained from trial subjects is accurate and valid. The presentation lays this on the table.
Areas Covered in the Session:
- The Investigators role in the clinical research process
- The historical background of why accurate data is essential for ensuring safety of study participants / patients.
- The purpose of ensuring that all data is accurate, legible, contemporaneous, original and attributable
- The regulatory requirements for care of source documents
- What "To Do" with regard to data including corrections?
- What to "Never Do" with regard to data handling?
- What is the best time to review "Raw Data"?
- What documents does the FDA review - always?
- Learn who is responsible for "Data Management
- What is the history of the drug / device regulations?
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