Guidance for Phase 2 Restart of Clinical Research (July 1-Dec. 31, 2020)

Important update on Aug. 28: Phase 2 Restart of Clinical Research has been extended until Dec. 31, 2020. 

Information released on June 17, 2020 on behalf of Betsy Nugent, MSPH, CCRP, Chief Clinical Research Officer. For previously released Phase 1 guidance, click here

Please note that while plans exist to reopen face-to-face research, the landscape remains uncertain and suspensions of face-to-face research interactions may occur. Our concern is first and foremost for the safety of our research participants and staff. Where there is potential to continue with remote interactions, those will remain preferable for the foreseeable future.

Additionally, the document “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” may provide further clarification for research teams engaged in FDA regulated research activities on the need to focus on participant safety and strategies for remote conduct of study activities or appropriate delays in study activities.

Information for Researchers wanting to reopen research involving face to face interactions during Phase 2 (July 1-Dec. 31)

Information for all researchers

  • General guidelines:
  • Every effort should be made to continue with remote methods of research subject and sponsor interaction.
  • Research study activity that CANNOT be done remotely must have plans for appropriate protection of non-clinical staff and research participants must be in place including but not limited to:

Resuming Research

  • Studies will be reviewed according to the ability of the organization to adequately support the research and overall prioritization. The review will account for study activities that may impact ancillary departments (lab, imaging, Pharmaceutical Research Center (PRC), CRU, etc.
  • If research is performed in a UW Health facility, the review process will also include review and approval by Infection Control and UW Health prior to approval
  • Site selection and site initiation will need to continue to be conducted remotely for the foreseeable future.
  • Remote monitoring is still required method for the foreseeable future.
  • New clinical trials should be submitted to the Clinical Research Restart Team for review, along with existing studies restarting in Phase 2.
  • Sponsors have reprioritized research, so please check with the sponsor prior to opening new research protocols to ensure it is moving forward as planned.
  • Many of the ancillary departments (Pharmaceutical Research Center (PRC), Lab, CRU etc.) that support critical components of new initiation of clinical trials may also be working in many other areas of research, including prioritized COVID-19 studies. To ensure availability of ancillary services to support new research protocols, please confirm capacity with these departments prior to applying for initiation of new research studies.

Instructions/Process for Departments/Units/Centers:

  1. For studies that have remained closed during Phase 0 and Phase 1 of reopening, we are asking that departments, units or centers, complete the Departmental Prioritization Spreadsheet and email to Rochelle.Rannow@wisc.edu.
  2. Studies approved in Phase 0 (essential research) or Phase 1 (direct benefit/no additional risk) do not need to be submitted on the prioritization spreadsheet for SMPH approval.
  3. The Clinical Research Restart Review Team will review all departmental requests received by June 25 to coordinate overall research restart and will respond by June 30 to departments with approval or modifications. Spreadsheets not received by June 25 will be reviewed using a rolling review process.
  4. The Clinical Research Restart Team will support reopening of clinical research across SMPH/UW Health and will assist in balancing the available resources to support research with the needs of individual departments to phase in remaining clinical research over the Phase 2 time period.
  5. While not all studies will be able to open on July 1, every effort will be made to balance priorities for reopening and ensure each department can quickly start to phase in research activities over the period from July 1-Dec. 31 (Phase 2).
  6. Any questions about Phase 2 restart may be directed to Betsy Nugent, Chief Clinical Research Officer at enugent2@wisc.edu