Patient Eligibility, Medical Histories, and Their Regulatory Implications Click Here to purchase Contact Hours Speakers:Barbara Rusin, MS, Senior Manager Regulatory Compliance, MMS
Program Agenda:
- 4:30 – 6 pm – Registration & Networking
- 6:00 – 7:30 pm – Educational Presentation
- 7:30 – 8:00 pm – Q&A
- 8:00 – 8:30 pm – Networking
Program Description: Barbara Rusin, Sr. Manager Regulatory Compliance at MMS Holdings Inc., and a former FDA Investigator, will be presenting “Everyone Has a Medical History Worth Knowing – Especially Your Study Patient.” She will discuss regulatory implications of enrolling ineligible subjects – to the sponsor and clinical site – and how to prevent this by obtaining and properly reviewing medical histories, and what to do when records are not readily available. The presentation will also touch on the differences in the regulatory landscapes of the US and the EU regarding patient eligibility, health records, and study waivers.
Upon completion of this Seminar, attendees should be able to:
- The regulations and guidelines relevant to enrollment of eligible subjects in the EU and US
- Why enrollment of an ineligible subject is so concerning to regulatory authorities and the impact on study analysis
- Regulatory outcomes of enrollment of ineligible subjects
- What medical histories are necessary and how to maintain adequate documentation
- How to review medical histories and manage conflicting information
- Difficulties with obtaining medical histories
- What to do when medical histories are not readily available
- Use of waivers in US vs EU
Target Audience:
- CRCs
- CRAs
- Investigators
- Auditors
- Project Managers
- Regulatory Affairs/Compliance
- Quality Assurance
- Clinical Research Administrators
Registration Cost: $20 Chapter Members; $35 ACRP Members; $35 Non-Members
Contact hours: 2.0 ACRP Contact Hours
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program.
Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
$0 Chapter Members
$15 ACRP Members
$30 Non-Members
Refund Policy: No refunds
Level: Not specified