Clinical Research: Return to Work and Checklist 

June 26, 2020

Dear Clinical Research Community,

Thank you for your partnership in ensuring a safe restart to on-site clinical research that was postponed due to COVID-19. As outlined in the most current guidance, we are now allowing the category of postponed projects (so-called Category 3 clinical research) to resume on-site but at a reduced density of research team members and participants (12.5%). Importantly, COVID-related research and research essential to the health of the participant (Category 2) have continued on-site throughout. The Category 3 "restart" has been in place approximately one month, and we are actively monitoring its impact.

As we consider moving to phase 2 of clinical research activities (with 25% of Category 3 research team members and participants on-site), the following indicators provide a framework for decision-making:

  • A low, stable prevalence of COVID-19 infection in San Francisco;
  • The ability to monitor and protect our community through testing, contact tracing, isolating, and supporting those who are COVID-19 positive or exposed;
  • The ability of our hospitals and health systems to handle surges in COVID-19 cases;
  • Adequate infrastructure and support services to safely support on-site research personnel and activities and enable physical distancing;
  • The ability to determine when to reinstitute certain limits to on-site research, if necessary.

We believe we currently meet four of these five indicators, with adequate infrastructure and support services being the one unmet. Specifically, clinical researchers report challenges in: (1) acquiring personal protective equipment (PPE), (2) arranging COVID-19 testing for appropriate participants, and (3) ensuring clinical research coordinators (CRC) and other research staff are trained and supported on COVID-19 policies. Important progress has been made in each of these areas as described briefly in the following paragraphs.

Personal protective equipment (PPE): Decisions regarding the use of PPE for clinical research procedures should follow UCSF Health's COVID-19 epidemiology and infection control guidelines. Clinical researchers can now obtain PPE directly through Bear Buy COVID Catalog. In addition, UCSF is making available PPE “WeCare” Packages to all units.

PPE WeCare Package

The WeCare packages are unit specific. One package per active unit is available, with no constraints on type of unit. If you’re an active admin unit, class, or clinical team, you will receive one package. One package contains:

  • 6 boxes of gloves
  • 20 reusable cloth masks
  • 1 64oz bottle of hand sanitizer with pump

The link to request a “WeCare” package is available here: http://tiny.ucsf.edu/WeCare

Additional PPE is available via our Bearbuy COVID catalog. If your group has specific needs that would be better addressed programmatically, contact the UCSF Emergency Management at [email protected].

Research participant COVID-19 testing: Pre-visit RT-PCR COVID-19 testing (CPT 87635 – infectious agent detection by nucleic acid DNA or RNA amplified probe technique) is required for research participants who will be undergoing aerosol generating procedures (AGPs). Check your local health facility’s policies on Aerosol Generating Procedures (AGP). A list of high-risk AGPs and associated PPE recommendations at UCSF Health can be found online. As with all research encounters, RT-PCR COVID-19 testing should be ordered in APeX and linked to the applicable research study.

For instructions on linking encounters, please reference the APeX User Guide for UCSF Clinical Research Coordinators (CRCs).

CRC/research staff training and support: Our clinical research staff requires training in infection control and COVID-19 to ensure proper conduct of clinical research visits. There are several COVID-19-related resources developed for research staff that can be found on the UC Learning Management System (LMS):

  • COVID-19 and Working Onsite at UCSF (REQUIRED: should be completed ASAP by all employees if not already done)
  • UCSF Health Annual Safety Training
  • UCSF Health Annual Infection Control Training for Ancillary Staff
  • Bloodborne Pathogens
  • Safe Shipping of Biohazards

After logging into the UC Learning Management System, you can find “COVID-19 and Working Onsite at UCSF” listed under the “Required Training” tab. For the other courses above, click the “Find a Course” tab, and search for the name of the course you want.

To support clinical research teams in returning to work, we have developed a Return to Work Checklist that contains useful information and links for general considerations and research participants.

Over the next week, please let us know via [email protected] if you have continued difficulty with any of the above three topics. We are hopeful that with these items addressed, we will be able to advance to phase 2 in the near future.

Sincerely,

Lindsey A. Criswell, MD, MPH, DSc
Vice Chancellor of Research
Professor of Medicine and Orofacial Sciences