Ramp Up Protocol Review Process

2

Step Two

Requests to activate a currently approved study or a new study (except for UCH only studies) must complete the questionnaire and provide the requested supporting documents.

3

Step Three

Please note that any changes made to the calendar of events to minimize risk for participants will need the normal regulatory and operational reviews prior to implementation such as:

Process to obtain approval for utilization of CU Anschutz Clinical Space for clinical research visits:

  1. A COVID official for the research space must be appointed by contacting: alison.lakin@cuanschutz.edu
  2. The COVID official must complete the required training
  3. The COVID official in collaboration with the clinical research space leadership must develop a COVID space management plan.
    1. Architectural drawings should include
      1. Use to identify traffic patterns – better to have separate entry and exit points
      2. Space utilization capacity
      3. Biospecimen work flow pattern
      4. Bathroom management
    2. Use the Clinical Research Reconstitution Plan 5.15 to develop a space management plan to include:
      1. Space management and utilization
      2. Space cleaning plan
      3. Employee/faculty COVID screening plan
      4. Employee/ faculty occupancy
      5. Participant screening process and management
      6. Participant use of space including infusion room management, procedures etc
      7. Visitor management
    3. Once the relevant documents have been developed then the COVID official should submit the request for review and approval of the plan

     

Submit the request for review

A prioritization committee has been established to review all COVID-19 studies initially and again before they are open to accrual. 

The committee consists of faculty clinicians and researchers who care for patients with COVID-19 with the aim of: 

  • Minimizing the impact of research activities on essential clinical care 
  • Ensuring that the research activities are feasible under current clinical care
  • Ensuring that there are not competing studies seeking to enroll the same population
  • Minimizing the use of PPE for research   

All requests should complete: