Protecting Research Subjects and Patients: Investigator-Initiated Trials with and without and IND or IDE
Speaker: Patty Mendoza, BA, BSN, RN, CCRC, CHRC, CCRP
Program Agenda:
- 3:50 – 4:00 pm – Registration & Networking
- 4:00 – 4:50 pm – Educational Presentation
- 4:50 – 5:00 pm – Q&A
- 5:00 – 6:30 pm – Networking 1:1 with speaker & ACRP Officers
This event will consist of social networking time with light snacks provided to registered attendees and a presentation by a Regulatory Affairs Professional in an academic medical center for the purpose of reviewing care options and pathways provided by the FDA in an effort to protect research subjects and patients, through knowledge.
Upon completion of this Webinar, attendees should be able to:
- Examine Investigator Initiated Trials and the use of Investigational and non-Investigational Products to provide care to patients in an academic medical setting.
- Evaluate Investigator Initiated Trials in the clinical setting differentiating between research and patient care, including: documentation, regulatory submission to FDA and IRB
- Discuss the FDA Expanded Access Program to available to provide care and treatment to patients with few options.
- Demonstrate effective communications strategies to bridge research, clinical, and mixed care cases to support patient safety.
Contact Hours: 1.0 contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” 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
Please note snacks will be provided. Light snacks and drinksPlease RSVP to: Kathy Franco. 281-731-8871
Debra Dees 832-355-7501
Melissa Andrew 832-355-2797
Level: Intermediate
Target Audience: Clinical Research Personnel