Application process & FAQs

A CAFÉ application needs to be completed if any portion of the clinical trial will be performed either in the CTRC or by CTRC staff.

The CTRC can build a draft budget for the grant-please see the section titled "Pre-Award".

Study teams should submit the CTRC CAFE application as early as possible. Study teams may submit in-parallel with the IRB application using the IRB PRE# or submit the CTRC CAFE application after submitting the IRB application and receiving a full IRB#.

Study teams can submit after Open to Accrual, but will need to work with the funding source to ensure the executed study budget can absorb the cost of CTRC services.

Study teams can access the CAFE application here: http://jccc-sqlprod:8080/cafe_study_team.html.

The submitter will need to be on VPN and have completed some OnCore training. If you’re having trouble accessing the CAFE website, please contact the CRIS Help Desk.

Consenting research participants and physical exams fall under the purview of the provider. However, the CTRC has 2 nurse practitioners who would be able to assist the study team to perform these types of events and assessments. Please contact Margie Weiman, Unit Director, mweiman@mednet.ucla.edu, if you are interested.

CTRC rotational nursing staff do not sign sponsor DOAs. Instead, CTRC provides Research Responsibility Profiles and a memo to sponsor. Documents are available in BOX. 

Exception: CTRC Nurse Practitioners (NPs) may serve as sub-investigators and may sign sponsor DOA as a sub-investigator. Contact CTRC for additional information: Unit Director, Margie Weiman, mweiman@mednet.ucla.edu, and CTRC Services.

CTRC calibration logs are available in BOX

If the study has study-specific equipment calibrated by Clinical Engineering, please contact CTRC Services for a copy of the record.

CTRC CITI GCP training is available in BOX.

Please provide at least a week's notice and schedule the visit by emailing CTRC Services at CTRCServices@mednet.ucla.edu.

See the section on Project Initiation for a comprehensive answer on the steps to take to open a trial in the CTRC. For any questions, please email CTRC Services at CTRCServices@mednet.ucla.edu.
 

• Orders should be placed and signed by the investigator by 2 pm the day prior to the patient visit in the CTRC.
• Orders should be placed in the visit encounter, not an Orders Only encounter.
• Study teams can reference these tip sheets for assistance:
  • How to Access Future CTRC Encounters
  • How to Use Pre-Charting for Ordering

Members of the study team may NOT perform any clinical procedures in the CTRC including vital signs, ECGs, or point-of-care urine testing. It is considered to be out of scope for unlicensed personnel and is generally frowned upon by regulatory agencies and sponsors. 

Sometimes, study teams cannot place an order unless they have information collected at the current visit – for example, weight.  In this circumstance, all other orders should be placed the day prior, and the only missing order should be the one where information is needed.

The other example would be situations where the informed consent conference occurs on the day of the visit, and orders cannot be placed until the research participant consents.  In this case, please just let the CTRC know about this when making the schedule request.

The CTRC performs tasks with research participants based on TWO things: Orders and SmartPhrases.

Orders for the clinical trial should be specific and include directions for items like:

1. Medication administration and specifics related to this
2. Vital signs
3. Direct observation (RN staying at bedside)
4. Labs
5. Other assessments

SmartPhrases for the visit should be based on time so that things are done in the sequence required by the protocol.  It is also helpful to give additional information that doesn’t need to be in the orders, like “Contact study team after infusion complete."

The CTRC has one crash cart suitable for pediatrics and adults.  CTRC nurses are BLS, ACLS and PALS trained.  In emergency situations, we call 9-1-1 and initiate emergency care.

We have two main types of infusion pumps in the CTRC:

• Baxter SigmaSpectrum
• Medfusion 4000 syringe pump

Study teams have 3 options for scheduling:

1. Phone calls – 310-825-5225, Mon – Fri from 7 am – 330 pm. Sometimes talking on the phone about options for availability or projecting/forecasting visits is easier than going back and forth via email and we completely understand. 
2. Email – It is challenging to manage scheduling when individuals receive emails but we can’t cross-cover each other’s personal inboxes. For this reason, CTRC Services was created. You may continue to copy individual inboxes in addition to sending to the shared inbox especially if the request is urgent. 
3. CareConnect (CC) – CC inbasket is still an option and by it’s design is a shared inbasket. CC inbasket template restricts you to 1 patient 1 visit at a time. So it can be a challenge for bulk scheduling or unique scheduling requests. The CC inbasket detail/notes section has limited space. Email may be the best option for bulk scheduling or really unique requests. 

CTRC offers multiple options for scheduling to try and meet the unique needs of studies. Each medium has its advantages and disadvantages as noted above. Feel free to call 310-267-1029 or contact CTRC Services if you have any questions.

Please contact CTRC right away to notify us of any cancellations 310-825-5225.

CTRC has worked with parking to secure coupon codes for participants so that the cost of parking is billed to the study rather than the participant needing to pay for the parking at the time of arrival. 

1. The participant will check in with the CTRC front desk and provide their license plate number.
2. CTRC will then provide the participant with the coupon code for the day. 
3. The participant will go back out to the parking lot and enter the coupon code in the kiosk (enter coupon code instead of payment). 
4. At the end of the month, CTRC will send an invoice and parking report to the fund manager and study coordinator. 
5. The parking report will include participant name and MRN, date of parking, license plate, and cost of parking. 
6. Study FAUs will then be charged the parking total upon confirmation from the study team/fund manager.

CTRC administration will work with the study coordinator and fund manager to verify the study is eligible to participate in the CTRC parking coupon code program.

CTRC directions are available on BOX.

Email CTRC Services and request a report of charges using the IRB#.

When the Fund Manager is preparing to close the study FAU, email CTRC Services and request a final list of charges. The Fund Manager can use this report to reconcile the study ledger to confirm all CTRC charges have posted. If the study ledger is missing charges, the Fund Manager can email CRBP (UCLAHSCRBP@mednet.ucla.edu) with a request to post missing charges prior to study FAU close out.