Clinical Research Ramp Up Video

Ramp Up Protocol Review Process

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Step Three

If you have a portfolio of research use the Excel prioritization document to work through how you, as a research team, division or center would plan to prioritize your active and new studies optimizing the current staff and space limitations due to COVID.

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Step Four

Upon completion of the prioritization template it be submitted for approval by groups of studies but only if:

  • All the activities associated with the study will be conducted within a single CU Anschutz facility such as Barbara Davis Center (BDC), Adult CTRC, Anschutz Health and Wellness Center (AHWC), etc.
  • If for example, you are doing a research visit at any CTRC and sending a blood sample to RC2 that needs to follow step 5 not 4.

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Step Five

For individual protocols, protocols conducted at CHCO only, or protocols that need to use more than one facility on campus, similar questions to the content outlined in the template will be asked through the approval request form.
Documents requested include:

  • Protocol
  • Calendar of events with any changes annotated
  • Cover letter that will be submitted to the IRB describing changes, if applicable.

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Step Six

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 Seven

For research conducted at UCH only submit and email to UCH research administration central email box for UCH approval.  Do not use the RedCap form.

For UCHealth, any requested amendments must be submitted to the HSR amendment portal. UCHealth CTRC Inpatient submissions will follow this process. However, UCHealth CTRC Outpatient applications should also follow the guidance in point 5.

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Step Eight

For CHCO submission via this form also includes facility review by CHCO

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Step Nine

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.  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

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: