Utilizing Risk Assessments to Determine Adequate Levels of On-site & Remote Monitoring
50 Minute Video | Irfan Khan, Office of Compliance, DBM | OC | CDRH | FDA
As clinical studies continue to multiply in complexity and cost, complete on-site monitoring and surveillance has become more expensive and proven inefficient. In response, manufacturers have added additional provisions to clinical protocols by including remote monitoring, which allows clinical executives to better manage both time and monetary resources while promoting safety and efficiency. In order to utilize a variety of monitoring schemes effectively, a clinical risk-based assessment is crucial and should be included in monitoring planning prior to the start of a study and adapt as the trial evolves. A greater understanding of risk-based assessments will help the industry successfully prepare for and execute risk-based monitoring plans for on-site and remote locations.
- Overview of the requirements for risk-based monitoring
- Risk-based monitoring methodology development and application
- Comparing risks associated with on-site versus remote monitoring
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Clinical Research
- Clinical Affairs
- Clinical Operations
- Regulatory Affairs
Please note that the length of Mr. Khan’s presentation will be approximately 30 minutes to 40 minutes in length and the remaining time will be dedicated to Q&A; therefore, the program may run between 45 and 60 minutes in total.
Operations and Outreach Lead Consumer Safety Officer
Office of Compliance, DBM | OC | CDRH | FDA
Irfan Khan is the Operations and Outreach Lead for the Division of Bioresearch Monitoring within the Office of Compliance for the Center for Devices and Radiological Health. In addition to Mr. Khan’s core DBM responsibilities of helping to ensure data integrity and subjects’ safety in clinical studies; he specializes in electronic clinical data issues. Mr. has presented to the industry at various forums and worked on several FDA guidance documents. Mr. Khan received his B.A. in Computer Science and B.S. in Biology from the George Washington University, and M.S. in Biotechnology with concentration in Regulatory Affairs from the Johns Hopkins University. Mr. Khan has been with the Food and Drug Administration since 2009. Prior to joining the FDA, Mr. Khan worked for a Contract Research Organization as a Clinical Research Associate on various phase I-VI drugs and devices studies.
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