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.
- Keep a copy of the contact list in a secured off-site location.
- Provide research participants with a contact number for the study personnel.
- Coordinate an alternative site to conduct study visits.
- Establish a process to unblind 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 unblind studies.
- Establish partnerships with other academic institutions so collaborative emergency sites are available.
- Ensure all electronic research records are backed up and retrievable from a remote location.
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.
- Secure all clinical trial research records, both paper and electronic format.
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…
- Contact the sponsor to discuss any impact on the protocol.
- Resume the protocol timeline as soon as practical.