UCLA Clinical Trial Rapid Activation Business Services

Effective November 1, 2025

UCLA Health is committed to accelerating clinical trial drug discovery by offering trial sponsors an elective Clinical Trial Rapid Activation Business Services. This service line is designed to accelerate clinical trial start-up through strategic resource deployment of specialized Rapid Activation Coordinators, department project managers, and proprietary AI-powered Rapid Activation Tracking tools and dashboards that enable activation task management, transparent role delineation, and timely issue intervention and resolution.

Rapid Activation Business Services include the following additional infrastructure, staffing support, and technological tools:

Dedicated Rapid Activation Coordinator: Specialized staff members assigned exclusively to oversee and coordinate activation tasks across departments.
Rapid Activation Tracking: Access to self-service reporting and tracking tools that provide sponsors with transparent visibility to study activation progress, assigned organizational representatives across key activation tasks, and key performance indicators to assess study activation performance.
Enhanced Project Management: Assigned study team project manager and dedicated UCLA Escalation Contacts (as defined below) that coordinate rapid issue triage, response, and resolution across UCLA Health clinical trial administration.

Rapid Activation Timelines & Fees

Applicable fees are based on, and fund, additional operational resources, assigned Rapid Activation Coordination staff efforts, technology development and maintenance, and administrative resources necessary to facilitate and maintain UCLA Rapid Activation Business Services. Clinical trials that qualify for, and elect Rapid Activation Services, shall include the following budget terms in industry clinical trial agreement payment terms / budget exhibit:

Service	Service Cost	Indirect Cost (33%)	Total Cost
UCLA Rapid Activation Business Services	$30,600	$10,098.00	$40,698.00

Rapid Activation Qualification (Prerequisites) Checklist

To qualify for Rapid Activation Services, clinical trials must meet the following prerequisites:

☐ IRB Reliance: Clinical trial must leverage a UCLA approved & contracted IRB reliance agence, as defined here.

☐ Clinical Trial Agreement (CTA): Clinical trial must leverage an existing and current UCLA master CTA, or mutual acceptance of UCLA contracting and authorized sponsor representative to leverage a recently executed UCLA CTA as the contract terms for the clinical trial requesting rapid activation services. For industry sponsors interested in either confirming currency of a UCLA-industry clinical trial master agreement, or sponsors interested in establishing an industry clinical trial master agreement, please contact Tamika Merrick, Director, UCLA Clinical Trial Contracts & Strategic Relations at TMerrick@mednet.ucla.edu.

☐ UCLA Standard Research Pricing: Clinical trial budget must comply with UCLA’s Clinical Research Pricing Policy 915.1 and UCLA’s annual clinical research charge master. Standard clinical research administrative fees are published annually and available here.

☐ Sponsor Response Requirement: Sponsor agrees to respond and resolve all UCLA Rapid Activation related inquiries and requests within three (3) business days of receipt. In the event a UCLA Rapid Activation related inquiry and/or request is not resolved by sponsor with three (3) business days, total calendar days between each UCLA inquiry/request through each sponsor resolution of inquiry/request shall be subtracted from the total Rapid Activation Time.

☐ Sponsor Escalation Contacts: Sponsor agrees to designate a sponsor representative as a single point of contact for escalation, in the event Sponsor Response Requirement is not met, as well as a backup contact, in the event primary Sponsor Escalation Contact is unavailable. Sponsor Escalation Contact information to include e-mail addresses and direct phone number.

☐ UCLA Escalation Contacts: UCLA agrees to designate a UCLA Rapid Activation Coordinator as a single point of contact in the event UCLA representative(s) are unavailable or unresponsive, as well as a backup UCLA Escalation Contact, in the event primary UCLA Escalation Contact is unavailable. UCLA Escalation Contacts information to include e-mail addresses and direct phone number.

Defined Terms and Milestones

UCLA Business Hour(s) & Business Day(s): For purposes of UCLA’s Rapid Activation service line, UCLA Business Hour(s) are defined as 8 AM Pacific Standard Time to 5 PM Pacific Standard Time. UCLA Business Day(s) are defined as Monday, Tuesday, Wednesday, Thursday and Friday, except for University recognized holidays and closures. In the event a required document or sponsor response, as defined below, is received during non-UCLA Business Hour(s) or non-UCLA Business Day(s), the date of receipt of such document or response shall be defined as the most subsequent UCLA Business Hour on the most subsequent UCLA Business Day.
Rapid Activation Initiation Documents (“RAID”) Checklist: The minimum documents required by UCLA to initiate Rapid Clinical Trial Activation, which include the following IRB reliance submission-ready documents:

☐ Protocol

☐ All informed consent form(s)

☐ Investigator’s brochure

☐ Investigational product manual (drug / device)

☐ Clinical-practice-ready laboratory, pathology, and imaging manuals, as applicable

☐ Draft clinical trial agreement with applicable exhibit(s)

☐ Draft clinical trial budget

Rapid Activation Initiation (e.g., Day 1): Initial UCLA Business Day of UCLA’s receipt of Rapid Activation Initiation Documents (“RAID”). In the event RAID documents are not received on the same UCLA Business Day, Rapid Activation Initiation will be defined as the UCLA Business Day of receipt of the last (e.g., most recently received) document.
Rapid Activation Completion: latest date (e.g., most recent date) of completion of the following required activation tasks: (1) IRB approved protocol and consent; (2) applicable UCLA ancillary department approvals/waivers; (3) applicable Medicare Coverage Analysis and UCLA financial activation procedure; (4) budget terms finalized and mutually accepted by UCLA and sponsor; and (5) contract terms finalized and mutually accepted by UCLA and sponsor.
Rapid Activation Time: The calendar days that have elapsed between Rapid Activation Initiation (as defined above) and Rapid Activation Completion (as defined above). For example, if Rapid Activation Initiation is September 1, 2025 and Rapid Activation Completion is November 12, 2025, then Rapid Activation Time is 72 total days ((Sept 1 – Sept 30 = 30 days)) + (Oct 1 – Oct 31 = 31 days) + (Nov 1 – Nov 12 = 12 days) = 72 total days).

Cancellation and/or Termination

In the event Sponsor cancels, terminates, and/or suspends the study activation process after the initiation of Rapid Activation Services, the full Rapid Activation Fee shall be promptly due and payable to UCLA. This fee compensates UCLA for the resources allocated to the subject trial and efforts expended in initiating the rapid activation process.

Transparency & Ethical Standards

Applicable fees fund additional Rapid Activation resources, associated staff efforts, technology development and maintenance. Please note, Rapid Activation Services are optional. Sponsors can choose standard activation (no applicable rapid activation fee) without penalty or bias. Sponsor election of Rapid Activation Services do not influence UCLA clinical trial selection, prioritization, participant enrollment efforts, nor trial outcomes. Applicable fees are paid by clinical trial sponsors directly to the institution, not individual physicians, and thus, shall not influence physician referrals nor volume of patients.

Applicable fees are fixed, published and applied uniformly, reflecting fair market value (FMV) for incremental work and resources provided.

Contact Information

For questions or interest in UCLA’s Rapid Activation Clinical Trial Business Services, please contact:

Bishoy Anastasi
Senior Director, Research Finance & Strategy
UCLA Dean’s Office of Clinical Research
UCLA Clinical & Translational Science Institute
BAnastasi@mednet.ucla.edu