Policies and guidelines for phased reintroduction of CTRC clinical research


All CTRC research must comply with Anschutz Medical Campus (AMC) and affiliate hospital policies. Prior approval is needed to restart any CTRC protocol. This is a short guide to the resources that you will need to determine when and how to apply for reactivation of your CTRC research protocol/s. For more about group information, please see our definition of clinical research study priority groups.


CTRC Research Restart Proposed Schedule of Events
LocationGroups currently being reviewed and scheduledEarliest date for next group to be reviewed and scheduled
UCH OP1, 2, 3a, 3b, 3c, 3e, 3f, 4a, 4cJan 3 for Groups 3d, 3g, 3h, 4b, 4d, 4e, 4f, and 5
UCH IP1, 2, 3a, 3b, 3c, 3e, 3f, 4a, 4cJan 3 for Groups 3d, 3g, 3h, 4b, 4d, 4e, 4f, and 5
CHCO OP1, 2, 3a, 3b, 3c, 3e, 3f, 4a, 4cJan 3 for Groups 3d, 3g, 3h, 4b, 4d, 4e, 4f, and 5
CHCO IP1, 2, 3a, 3b, 3c, 3e, 3f, 4a, 4cJan 3 for Groups 3d, 3g, 3h, 4b, 4d, 4e, 4f, and 5
PN CTRC1, 2, 3a, 3b, 3c, 3e, 3f, 4a, 4cJan 3 for Groups 3d, 3g, 3h, 4b, 4d, 4e, 4f, and 5

All protocols must be submitted and approved through the AMC REDCap portal before any CTRC visits, including mobile nursing, can be scheduled. Applications for exceptions to Group restrictions should also be submitted through the AMC REDCap portal, providing a compelling argument about why the study should remain open for face-to-face research visits despite Severe Risk status and how the study will comply with current state and local public health requirements if it were to remain open.

Please submit one application per protocol; multiple protocols per application will not be reviewed by the CTRC. If you have already applied for protocol reactivation through the AMC portal and received CTRC confirmation of your priority Group number, but were denied approval because your group was not yet activated at the CTRC, you do not need to reapply through the portal.

Preparing our Research Participants

  • Study staff must conduct a participant pre-screening 24-72 hours before every CTRC visit and require that participants arrive wearing a face covering.
  • Upon arrival to the institution, participants will complete institutional specific screening on the day of their visit, including questions, and have their temperature taken.
  • At some sites, study staff may be required to meet the participants at the entrance to the building and escort them to the CTRC. Check for site-specific information at University of Colorado Health, Children's Hospital Colorado, or Anschutz Medical Campus.

Study Team Preparation

  • To ensure that we do not exceed strict capacity limits, study staff are required to complete COVID CTRC personnel number tracker designating the names of staff members that will attend each visit. This form must be completed by 9 am the day prior to the visit (Friday for Monday visits). Only personnel listed on this form will be permitted to enter the CTRC. Please limit staff to only those essential to complete the visit.
  • Study team members should arrive wearing a face covering.
  • The study team members will be screened per institutional guidelines.
  • Study team members who plan to attend a CTRC study visit are responsible for checking all relevant building access and PPE guidelines before entering the CTRC.
Please see the Step-by-Step Guide to Clinical Research Ramp Up for detailed AMC information. The UCH CTRC Outpatient Clinic will use the AMC application process. However, UCH CTRC Inpatient protocols should use the UCH application process.

AMC Guidelines





Due to capacity restrictions, all tasks that can be conducted remotely will continue to be conducted remotely. If you do not need to be in the CTRC clinic space for a specified face to face participant encounter, please do not enter the space. Study teams will be encouraged to reduce the number of study personnel needed at a visit. If one person can be delegated to do all tasks at the visit, that is the best practice and when possible, schedule multiple visit for a single coordinator on the same day so that you are entering the facility less days per week. This will allow the CTRC to schedule more research visits per day.

If you have a CTRC visit that does not require fasting, please try and schedule after 10am, whenever possible. This will facilitate all protocols obtaining equal access to CTRC appointments

Study staff are responsible for checking all relevant building access and PPE guidelines before entering the CTRC. This guidance changes frequently and it is your responsibility to comply with the most recent regulations. Check the tab for the CTRC that you will be using to access this information.

Questions for the UCH CTRC should be directed to Diane Branham.

Questions for the CHCO CTRC should be directed to Lisa Lewis.

  

Report a COVID positive test result within 72 hours of the last CTRC visit.

CTRC Access Request Form

This form must be completed by 9am the day prior to the visit or your visit will be cancelled. If no staff members will be present, you must complete the form with 0 as the number of study staff. Only staff members named in this form will have access to the CTRC for the study visit.

UCH CTRC IP and OP units are currently accepting Group 1, 2, 3a, 3b, 3c, 3e, 3f, 4a, 4c applications only.

Effectively immediately, the UCH inpatient (IP) CTRC will not be accepting new appointments, except for Group 1 and 2a-d studies. Group 1 and 2a - e studies will not be able to make automated appointments through the CTRC Scheduler system, so please email all UCH IP CTRC appointments with as much advance notice as possible.

All CU-AMC employees must report to a screening location and obtain a wrist band before coming to the UCH OP CTRC, per AMC policy. Investigators and study team members without a valid wristband will not be allowed access to the UCH OP CTRC.

UCH Guidelines






Current CTRC OP hours are Monday through Thursday, 7am – 4pm. Select OP Fridays, 7am – 1pm, and IP weekends will be available for scheduling at noon on October 30:

  • OP Fridays
    • November 6
    • November 13
    • November 20
  • IP weekends
    • November 7 - November 8
    • November 14 - November 15
    • November 21 - November 22
    • December 5 - December 6
    • December 12 - December 13
    • January 9 - January 10
    • February 6 - February 7
    • February 20 - February 21
    • March 6 - March 7
    • March 20 - March 21

UCHealth has revised its general guidance for access and presence of research personnel at UCHealth locations, including the UCH IP and OP CTRCs:

  • All investigators, their research staff, and CTRC staff, are required to wear a surgical or procedural mask at all times while on the CTRC Inpatient or Outpatient Units. The mask must cover the nose and mouth.
  • Investigators, research staff, and CTRC staff are not permitted to wear cloth masks or gators on the CTRC Inpatient or Outpatient Units.

If you have already applied for protocol reactivation through the AMC portal and received CTRC confirmation of your priority Group number but were denied approval because your group was not yet activated at the CTRC, you do not need to reapply through the portal. If your study uses only CTRC space, you will receive an approval email and can proceed. If your protocol utilizes any non-CTRC AMC space such as Barbara Davis Center, RC1 or the Pharmacy Building, your application will need AMC approval before receiving CTRC review. Please wait for AMC to call for your Group number before proceeding with your research restart portal application.

Approved protocols in active groups may schedule visits as soon as the protocol is reactivated by CTRC Scheduler, which usually occurs within three business days of final approval. You will receive an email when your approved study is open for scheduling. You must reply to this email for your study to be re-activated.

Study staff must follow all UCH Outpatient CTRC guidelines and rules for both regular study visits and study visits involving COVID-19 positive participants.

UCH has updated the way that COVID status is displayed in Epic. Please familiarize yourself with the new view.

Currently, all CU-AMC employees must report to a screening location and obtain a wrist band before coming to the UCH OP CTRC, per AMC policy. Investigators and study team members without a valid wristband will not be allowed access to the UCH OP CTRC.

UCH IP CTRC is exempted from the UCHealth requirement for COVID-19 testing pre-admission except for aerosolizing procedures (bronchoscopy, max or stress exercise testing). Participants must still be pre-screened prior to admission by study staff and will also be screening upon CTRC arrival. Check the UCH guidelines for the latest screening questions.

For visits involving aerosolizing procedures or where COVID testing is required as part of the protocol, for both IP and OP visits, COVID-19 tests need to be scheduled and ordered in Epic and the research project will be charged for the test. These tests will require an amendment submitted through the Human Subject Research Portal to have the test added to the calendar/MCA. While the amendment is pending, please utilize the billing notes to designate that these tests are to be billed to research. The participant will need to have the test done at a UCHealth designated COVID testing center. Results may take 1 - 2 days to return so this should be performed 48-72h before of the study visit. Contact Laurie Blumberg-Romero with any questions.

Due to capacity restrictions, all tasks that can be conducted remotely will continue to be conducted remotely. If you do not need to be in the CTRC clinic space for a specified face to face participant encounter, please do not enter the space. Study teams will be encouraged to reduce the number of study personnel needed at a visit. If one person can be delegated to do all tasks at the visit, that is the best practice and when possible. This will allow the CTRC to schedule more research visits per day.

If you have a CTRC visit that does not require fasting, please try and schedule after 10am, whenever possible. This will facilitate all protocols obtaining equal access to CTRC appointments.

Study staff are responsible for checking all relevant building access and PPE guidelines before entering the CTRC. This guidance changes frequently and it is your responsibility to comply with the most recent regulations.

You should be able to access UCH information, using your AMC login. If not, please contact UCHealth Admin. Questions for the UCH CTRC should be directed to Diane Branham.

CHCO IP and OP CTRCs, including mobile nursing services, are currently accepting 1, 2, 3a, 3b, 3c, 3e, 3f, 4a, 4c applications only.

If you have already applied for protocol reactivation through the AMC portal and received CTRC confirmation of your priority Group number but were denied approval because your group was not yet activated at the CTRC, you do not need to reapply through the portal. If your study uses only CTRC and CHCO space, you will receive an approval email and can proceed. If your protocol utilizes any non-CTRC AMC space such as Barbara Davis Center, RC1 or the Pharmacy Building, your application will need AMC approval before receiving CTRC review. Please wait for AMC to call for your Group number before proceeding with your research restart portal application.

CHCO Guidelines





CTRC Access Request Form


This form must be completed by 9am the day prior to the visit or your visit will be cancelled. If no staff members will be present, you must complete the form with 0 as the number of study staff. Only staff members named in this form will have access to the CTRC for the study visit.

You should be able to access CHCO information, using your CHCO login If you do not have a CHCO login or cannot access this content, please contact Michelle Middleton to gain access.

CHCO OP CTRC hours are currently Monday through Thursday, 7:00 am - 5:30 pm. We are open select Fridays 7:00 am - 1:00 pm: November 6, 13, 20 and December 4, 11 and 18.

Please review the capacity of each CHCO CTRC space, including shared space.

Due to capacity restrictions, all tasks that can be conducted remotely will continue to be conducted remotely. If you do not need to be in the CTRC clinic space for a specified face to face participant encounter, please do not enter the space. Study teams will be encouraged to reduce the number of study personnel needed at a visit. If one person can be delegated to do all tasks at the visit, that is the best practice and when possible, schedule multiple visit for a single coordinator on the same day so that you are entering the facility less days per week. This will allow the CTRC to schedule more research visits per day.

If you have a CTRC visit that does not require fasting, please try and schedule after 10am, whenever possible. This will facilitate all protocols obtaining equal access to CTRC appointments.

Study staff are responsible for checking all relevant building access and PPE guidelines before entering the CTRC. This guidance changes frequently and it is your responsibility to comply with the most recent regulations.

See more in our CHCO FAQ

Questions regarding this should be directed to Lisa Lewis.

Return to work summary:

  • You will need to wear a cloth face covering as you enter CHCO. 
  • Only enter through the employee entrance.
  • You will scan a QR code and complete a RedCap survey prior to entering the building. When you enter, you will have your temperature taken.
  • You will be issued a face mask if you will be in a clinical area.
  • If you are in a non-clinical area, you will continue wearing your cloth face covering.
  • Don’t come to work sick – Reminders –
    • If you don’t feel well, stay home!
    • If you feel ill, contact your supervisor for guidance.
    • Complete the daily health assessment and wellness check.
    • Wear the appropriate face mask for the area you will be working.
    • Follow 6 ft social distancing.
    • Clean and disinfect any and all equipment that you use

PN CTRC is open to Groups 1, 2, 3a, 3b, 3c, 3e, 3f, 4a, 4c only. Opening hours are currently 7am - 7pm, Monday - Thursday and 7am - 4pm on Friday.

All questions should be directed to Lisa Lewis.

Contacts

UCH CTRC COVID-19 Official

Thomas Campbell, MD
303-724-4929

UCH CTRC COVID-19 Coordinators

Clinical and Nursing Questions
Diane Branham
720-848-7901

Administrative Questions
Pam Allen
720-848-6665

University of Colorado Hospital Research Administration Office

Laurie Blumberg-Romero
303-724-9138

Anschutz Medical Campus

Alison Lakin
303-724-1010

Children's Hospital Colorado

Lisa Lewis
720-777-4700

Children's Hospital Colorado Research Questions (CHRE)

Jenae Nieman
720-777-3349