Emergency Preparedness Guidelines for Research Investigators

These guidelines aim to assist research investigators in ensuring the continuity of research operations during emergencies involving drugs and devices. Key actions include obtaining emergency contact numbers, providing emergency cards to participants, securing essential files, communicating with research services, informing participants about evacuation procedures, and reporting emergency procedures promptly.

• Emergency Preparedness
• Research Investigators
• Drug Safety
• Contingency Planning
• Research Continuity

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1. EMERGENCY PREPAREDNESS FOR EMERGENCY PREPAREDNESS FOR INVESTIGATORS INVESTIGATORS January 11, 2022

2. Objectives To provide guidance for research investigators in protecting the continuity of research, notably when drugs and devices are involved, in the event of an emergency in which normal events might be disturbed. To provide guidance to investigators in maintaining communication with their research participants and the Office of Research Services. 2

3. Pre-disaster Event Acquire all emergency contact numbers from study participants prior to the hurricane season. Give the IRB approved emergency cards to all active participants who are either taking study drugs or devices Make sure all the information (principal investigator name, phone number and email address) is accurate prior to giving it to participants 3

4. Pre-disaster Event cont. Make sure all files (study records, participant contact lists) that are necessary for the needs of participants are kept secure. If normal means of communication is not possible, please contact the Office of Research services or the IRB: (504) 568-4970 or 866-957-8472 Participants are also encouraged to use this phone number in the event they can t contact the principal investigator. 4

5. Drug and Device Guidance Keep participants informed about the steps to follow in the event of an evacuation or any other event that disrupts normal operations. All studies which involve drugs should follow their investigational pharmacy plan. All studies involving investigational devices should consult with study sponsors regarding contingency plans. 5

6. Reportable Events All procedures during an emergency event do not need to wait for IRB approval since there would not be sufficient time. All emergency procedures can be reported within 5 days when normal operations resume. 6

7. Post-disaster Event Researchers have the responsibility to provide all emergency contact information to LSUHSC s Office of Research Services within 72 hours after an emergency has been declared by the University. Email Dr. Jawed Alam (jalam@lsuhsc.edu), the Office of Research Services Executive Director, all your emergency contact information. Monitor the LSUHSC main page for updates: https://www.lsuhsc.edu/ 7

8. Emergency Contact Information Office of Research Services phone number: 504-568-4970 Emergency phone number: 866-957-8472 Office of Research Services email: IRBOffice@lsuhsc.edu Office of Research Services homepage: https://www.lsuhsc.edu/administration/acade mic/ors/irb.aspx 8

9. Save the Date! Date Time Topic 02/01/2023 12:00PM Informed Consents & HIPAA Authorization In Person and via Zoom; Details Coming Soon 03/01/2023 12:00PM Expanded Access Use of a Test Article 04/05/2023 12:00PM Regulatory Binders 9

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