Clinical Research Ramp Up Video

Ramp Up Protocol Review Process

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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.

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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:

  • IRB amendment approval
  • OnCore amendment approval
  • Contract amendment

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

  1. The COVID official in collaboration with the clinical research space leadership must develop a COVID space management plan with an architectural drawings that includes Biospecimen work flow pattern.
  2. Use the Clinical Research Reconstitution Plan 5.15 to develop a space management plan to include: employee/ faculty occupancy
  3. Once the relevant documents have been developed then the COVID official should submit the request for review and approval of the plan

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: