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Pandemic Management: Operational oversight in re-opening and “ramp down”

Throughout the COVID-19 pandemic, the clinical research community adapted to ensure that trials could be conducted safely. Certain processes and procedures can be put into place from an administration perspective that may alleviate the burden on the clinical research groups and ensure the safety of participants and staff. Prioritizing trials and having both re-opening and ramping-down processes in place can make either starting up or slowing research more efficient and reduce confusion.

 

  • Tab IconRe-Opening
  • Tab IconRamp Down
  • Tab IconResources

Considerations and best practices for re-opening.

Considerations

  • Safety is the primary consideration for staff and participants and is a shared responsibility. This includes the provision of PPE, cleaning supplies and utilization of space to maintain physical distancing in compliance with the institutional policy and the current status of re-opening.
  • Consider special safety precautions for at-risk populations. (e.g., look for ways to further minimize exposure for immunocompromised patients in clinic, at entrances/ exits, etc.)
  • To minimize risk of exposure to participants, carefully assess the benefits of continuing onsite visits, and consider identifying opportunities to integrate study visits into standard of care visits at the site. Remote activity, wherever possible, should be implemented with the aim to support a safe environment for clinical trial operations.
  • Consider taking an equitable approach to resumption of clinical trial activity.
  • If the trial protocol is not significantly altered, an REB amendment may not be required. Check with your REB on the best approach proactively for guidance.
  • Institutions make the final decision on appropriate use of technology that may support remote activities (with and without patients). All solutions will need to be compliant with institutional privacy policies.
  • Institutions may consider establishing a COVID-19 committee and prioritize COVID-19 studies for REB review.
  • Researchers should check with REBs policies with respect to publicly declared emergencies. (see resources)
  • Sites will need to consider oversight processes, identify responsible people to oversee this process, and verify /document at the program level, PI level and study level.
  • Consider establishing a centralized industry communication strategy on process changes in order to reduce the burden on trial teams.
  • Consider regular meetings to ensure all new policies are communicated clearly and are well understood. Also, consider using a standardized communication method such as SBAR (see resources).

Best Practices

  • Pre-screening procedures and contact tracing processes for all on-site personnel and visitors will improve safety in re-opening.
  • Research activity levels should be aligned with clinical capacity levels.
  • When required, prioritize essential studies or essential visits within a study that have greatest potential to result in an effective intervention, prevent immediate side effects or long-term damage and result in the greatest quality of life improvements.
  • Have PIs attest that minimum conditions are met on safety and resources for their ongoing studies.
  • All changes to study processes must be reviewed and approved by sponsor and REB.
  • Documentation (and archiving) of all COVID-19 related communications and considerations around clinical need, risk to participants, resource availability is an important practice to provide protection from liability for COVID-19 exposure-related claims
    • (reference: Bill 218 has passed third reading: ‘provides protection from liability for COVID-19 exposure-related claims. Claims based “directly or indirectly” on an individual being potentially infected with or exposed to COVID-19 are barred if the defendant acted in accordance with applicable public health guidance and laws, or made a good faith effort to do so’)
  • SOPs must be maintained and amended where required to ensure all changes to operations are compliant and documented.
  • PIs and research teams should maintain a ramp down plan throughout re-opening phases.
  • Cross-training and contingency planning are essential to ensure that responsibilities can be performed regardless of sickness/absence within a research team.

Considerations and best practices for ramp down.

Considerations

  • Scale back of clinical activity and clinical research may be initiated by the following triggers:
    • The need to prioritize available resources to deliver care to the most urgent participants.
    • The need to create flexibility in staffing, enable redeployment as required.
    • The need to reduce COVID-19 exposure to staff and participants.
    • The need to preserve PPE.
  • Clinical research that is considered essential may be exempt from ramp down procedures.
  • Trials where participant visits are able to continue safely in a virtual/remote setting may be considered exempt from ramp down procedures.
  • To minimize risk of exposure to participants, carefully assess the benefit of continuing onsite visits, and consider identifying opportunities to integrate study visits into standard of care visits to the site.

Best Practices

  • All changes to study or process must be approved by the sponsor and REB.
  • Documentation (and archiving) of all COVID-19 related communications and considerations around clinical need, risk to participants, resource availability is an important practice to provide protection from liability for COVID-19 exposure-related claims:
    • (Note: Bill 218 has passed third reading and “‘provides protection from liability for COVID-19 exposure-related claims. Claims based “directly or indirectly” on an individual being potentially infected with or exposed to COVID-19 are barred if the defendant acted in accordance with applicable public health guidance and laws, or made a good faith effort to do so”)
  • SOPs must be maintained and amended where required to ensure all changes to operations are compliant and documented.
  • PIs and research teams should maintain a ramp down plan.
  • To support remote working practices, coordinator may consider: fix bullet
    • Access to files; how to keep files secure; how to work securely from home.
    • List of what files are taken and reconcile when returned.
    • Proper precautions for patient privacy (e.g., coordinator should call patients from a private number and delete patient number from call history).

Resources for Re-Opening

Resources for Ramp Down

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