In addition to the standard UM preparedness plans for safeguarding staff and securing the physical location, additional concerns must be addressed before and during an emergency situation for researchers with active clinical trials.
The objectives for PIs and Clinical Research Staff must include:
- A plan to continue FDA-regulated studies where investigational drugs or devices are involved.
- A capability of communicating with regulatory authorities.
- Procedures for access to investigational drugs and devices during a disaster, especially if an evacuation has disrupted normal research operations.
- Written documentation of the continuity plan for each clinical trial or category of clinical trial.
Before an emergency event…
- Ensure up-to-date list of research subjects is maintained with all contact information.
- Provide research participants with a contact number of the study personnel.
- Update the contact list for all research study-staff and distribute to each member.
- Keep a copy of the research contact list and study-staff in a secured off-site location.
- Coordinate an alternative site to conduct study visits, if feasible.
- Have a pre-arranged plan with the study Sponsor for securing study samples, investigational product and research data.
- Establish a process to un-blind studies in the case of a disaster and to provide investigational drugs for treatment purposes – this may require remote access by the research pharmacist who has the key to un-blind studies.
- Ensure clear procedures exist to secure and access investigational drugs and devices during a disaster.
- Establish partnerships with other academic institutions so collaborative emergency sites are available.
- Secure all clinical trial research records, both paper and electronic format. Document the process and inform the study team of the method and location.
- Ensure all electronic research records are backed up and retrievable from a remote location.
- Ensure all paper research records are kept in a safe and dry location, away from potential water damage.
- Always attempt to store data in non-proprietary or open standard formats for long-term software readability.
- Observe the 3-2-1 Data management rule:
- Have at least 3 copies of your data
- Keep these backups on 2 different media
- Store 1 backup offsite
- Review the University of Miami Emergency Preparedness Plan
Immediately before an emergency event…
- Contact research participants and provide direction regarding any medications or study visits.
- Confirm contact information with all participants.
- Complete as much study activity as possible in advance of the event, within the constraints of the protocol.
- Follow the pre-arranged plan for securing study samples, investigational product and research data (ship specimens to the Sponsor or relocate to a more secure alternate location).
During the emergency event…
- Ensure the safety of clinical trial staff and participants.
- Follow the lead of the clinical sites in moving participants to other areas.
Following the emergency event…
- Confirm the safety of clinical trial staff and participants.
- Verify the stability of the study participant’s samples, study drug, data, etc. and if necessary, arrange for their return.
- Document any damages and inform your supervisor.
- Contact the Sponsor to discuss any impact on the protocol.
- Resume the protocol timeline as soon as practical.
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