Life Cycle of a Clinical Trial

Feasibility Budget

For investigators writing grants and developing grant budgets, CTRC can build a feasibility budget so that estimates for clinical services administered in the CTRC can be accurate.  Submit a draft of the protocol or project plan to CTRC Services (CTRCServices@mednet.ucla.edu), as well as the date when the draft would be needed.  A phone call or Zoom meeting may be requested in order to develop the most accurate estimate for services. 

The CTRC understands that as the clinical design and protocol are reviewed by funding agencies and the IRB, there may be significant changes that may impact the cost of the study. Once the protocol is finalized and has been submitted to the UCLA IRB, please submit an application to the CTRC via the CAFÉ portal for a final budget and letter of approval.

CAFE Application

1.  To access the CAFE application, please ensure that you are connected to the campus network and fill out the application accordingly.
2. During the application review, if any reviewers have questions or comments about your protocol, they will contact you for additional information.
3. Once your protocol is approved, a copy of the CTRC budget and approval letter will be uploaded to OnCore.

Approval Time Frame:

• The Clinical & Translational Research Center operations committee meets every Wednesday to review and approve applications. Any CAFE applications submitted prior to 5 PM on Monday will be reviewed that week, while those submitted after 5 PM will be reviewed the following week.

Request A Protocol Manager

About 4 weeks before enrolling the first patient, study teams should request that a protocol manager be assigned to the clinical trial by emailing CTRC Services (CTRCServices@mednet.ucla.edu). The protocol manager is a CTRC staff member who can help the study team navigate the CTRC workflow by assisting with the following:

• Arrange a time for the protocol discussion (see below)
• Create the protocol summary that all other CTRC staff need to sign off on as having reviewed before caring for a patient on your clinical trial.
• Draft SmartPhrase(s) to help guide the flow of each visit.
• Assist with the validation of order sets to ensure that they will work for CTRC.

Schedule The Protocol Discussion

• A protocol discussion is a conversation between the study team, including the PI, and the staff of the CTRC.  During this conversation, the PI presents the study by explaining the disease and the drug or intervention being studied. During this conversation, the specifics regarding the conduct of the clinical trial are decided.  

• Protocol Discussions can be held via Zoom or in person and are usually held in the afternoons on Mondays, Wednesdays, or Fridays.  The protocol manager will help to schedule the most convenient time for both parties.

• After the protocol discussion, the protocol manager creates a protocol summary highlighting the important points that CTRC staff need to know to successfully provide care as required by the protocol.  The protocol summary is posted into our internal database, and each staff member signs off on it with a timed digital signature before caring for any patients on the protocol.   A report for monitors or sponsors can be provided regarding protocol education.

Orders  

• All patients seen in the CTRC must have orders entered through CareConnect.  These orders must be in place by 2 pm on the day prior to the visit to ensure that research participants are not kept waiting and that delays resulting in increased costs are minimized.
• For visits where only an uncomplicated blood draw or an ECG may be needed, study teams may be able to place orders ad hoc, meaning selecting the correct order from all of the available orders.  Here is a tip sheet on how to place research study kits.
• If your study team does not include an MD who can sign orders at UCLA, we do have nurse practitioners who can generate orders for study visits.  Please email CTRC Services for more information about this service.
• For more complicated studies, an order set, called a SmartSet, may be needed.  Oncology studies use Oncology Treatment Plans in some circumstances, and both of these sets of orders are built by CareConnect teams.  Please fill out a ticket in Service Now to start the build – Please allow 6-8 weeks for build and validation.

SmartPhrase

• Not all clinical trial visits will need to use SmartPhrase, but ones that are long and/or complicated will benefit from having them built.  The benefit of using a SmartPhrase is that the flow of the visit is very clearly laid out and all data required in the eCRF is noted as needing to be collected. 

Scheduling A Site Initiation Visit (SIV) or Site Qualification Visit (SQV)

Monitoring appointments may occur Monday – Friday 7 AM-4 PM, excluding UCLA University recognized holidays.   Monitoring appointment requests shall be sent to the Administrative Analyst and Unit Director by emailing CTRCServices@mednet.ucla.edu at least 2 weeks prior to the 1st day of the Monitoring Visit and include the following information:  

• IRB Number 

• Sponsor Name and Protocol Number 

• Visit Date (s) & Time 

• Name and contact information of the monitor 

• CTRC areas and regulatory documents that will be monitored  

Monitors shall be accompanied at all times by either the Admin Analyst or Unit Director while at CTRC. If the monitor requests to meet with additional staff members, please indicate in the email what staff (i.e. dietician, protocol manager, medical director). Monitor visits are scheduled for a max of 1 hour but may be extended with pre-approval from the CTRC Unit Director. 

CTRC Nurse Practitioners 

CTRC Nurse practitioners are available 5 days a week and can provide specialized assistance to help study teams operationalize their study at CTRC. They can work closely with Principal Investigators and sub-investigators to offer onsite provider coverage or backup coverage for patient study visits. Having a backup provider readily available to assist when needed provides studies with added flexibility at CTRC. The CTRC NPs can perform informed consent, history and physicals, adverse event documentation, and procedures such as skin biopsies and others.  Information about their credentials is provided below.

CTRC NP's Credentials

• Melanie Schmitz Raz, NP
• Stefanie Uechi, NP

Regulatory Information & Equipment 

Access to CTRC regulatory documents can be requested by emailing CTRCServices@mednet.ucla.edu.

Regulatory documents may include but are not limited to:

• Refrigerator temperature logs

• Equipment calibration logs

• Protocol-specific training

NOTE: Monitors will not have access to CareConnect, UCLA's electronic health record (EHR) program while visiting the CTRC.   

Scheduling Patients at CTRC

To schedule a patient at CTRC three options are available.

• Calling CTRC: (310)825-5225
• E-mailing CTRC Schedule Request:  CTRCScheduling@mednet.ucla.edu
• CareConnect Message-In Basket

Please include the following information when requesting an appointment:

1. Patient's MRN
2. Patient's Last Name
3. Appointment Date
4. Check-in Time
5. Check-out Time
6. PI's Name
7. IRB#
8. Any Additional Notes: (Example: type of visit or cycle and day. )

The patient's consent should be uploaded to CareConnect 48 hours prior to the appointment. 

For additional information please call the CTRC front desk at (310) 825-5225

NOTE: 

• Please note that appointments can only be scheduled up to 6 months in advance. If you need to cancel or reschedule an appointment, we kindly ask that you give us a 24-hour notice so we have time to accommodate another patient. 

Uploading Consent Forms onto CareConnet

See the Tip Sheet (PDF) on How to Scan a Signed Consent Form into CareConnect

CTRC Charges

Upon completion of  CTRC services study teams can request a full report of CTRC charges.

Please email CTRCServices@mednet.ucla.edu and include

• IRB #
• Report Start Date and End Date. 
• Email address where you would like the report to be sent.

Citation Information

 We ask that whenever using CTRC services please cite the UCLA CTSI grant below in any publication arising from services performed in conjunction with the CTRC. 

CTRC Source:  NIH / NCATS grant# UL1TROO1881