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March 2026: Issue 001

Welcome to the first issue of the ACTRI Center for Clinical Research (CCR) Monthly Newsletter. This newsletter will provide timely operational updates, process reminders, and upcoming events to support study teams using CCR services.

OPERATIONS UPDATES

 

Negative Pressure Rooms are Operational

The negative pressure rooms in the La Jolla Main Clinic are available for study use. Please contact Bernadette Cale at bcale@health.ucsd.edu for any questions.

 

Clinic SOPs Now Available Online

CCR Clinic Standard Operating Procedures (SOPs) are now accessible on the ACTRI website for easy reference:

Clinic SOPs
 

New Clinic Appointment Request Form Link

 Effective March 3

The Clinic Appointment Request Form link has changed effective Tuesday, March 3! Clinic operations and your ability to request appointments will not be affected.

Beginning Tuesday, March 3, use only the new link below. The updated form looks similar to the previous one but offers a smoother, more user-friendly submission process. The new link will also be posted on our website and in public-facing SOPs. Be sure to save the new link and remove any old bookmarks.

****Effective Tuesday, March 3, use this link**** New Form: https://forms.monday.com/forms/52899b211ec1b0a779025c077650d9d8?r=use1

 

eConsent and HIPAA Forms

Please be reminded that the ACTRI clinic participant chart must include a copy of the signed consent form and a copy of the signed HIPAA authorization form. For studies utilizing eConsent, you should print the complete PDF from DocuSign, ensuring the saved signature block is included. The IRB information, participant name, and signature(s) must be clearly visible on all documents. Please note that the HIPAA signature page must be separate from the consent signature page.

 

Protocol Deviation Reporting Update

The CCR Standard Operating Procedure (SOP) for filing an iReport has been finalized. This SOP will guide you on how to submit an iReport. The clinic requests an iReport be submitted for all protocol deviations so they can be tracked and promptly addressed. An iReport should also be used to report any high risk or safety concerns that occur in the clinic. Access the SOP using the below button.

Filing an iReport SOP

Since implementation and outreach to clinic users, only one iReport has been filed, which is a reflection of the overall strong compliance and care CCR staff and users consistently demonstrate. Please continue to follow the SOP and submit an iReport whenever a protocol deviation occurs to support compliance and quality monitoring.

 

Clinic Lab Operations Update

Effective immediately, to better protect the privacy and integrity of study samples, study team staff no longer have direct access to lab freezers or refrigerators. All access must be coordinated through an ACTRI clinic staff member, who will retrieve specimens and document the access in the freezer log. A lock has been placed on the –80°C freezer to support this process. These changes have been made in response to a recent access concern.

As a reminder, clinic staff should be the only ones bringing specimens to the lab. In the rare event that a study team member must drop off a specimen, it must be handed directly to a clinic staff member and recorded in the “Specimen Drop-Off Exception Log,” located near the Kit Drop-Off Log. Specimens should never be left on the counter. 

After-hours lab access requires advance coordination:

  1. Submit a Request Form
  2. Contact Bernadette Cale at bcale@health.ucsd.edu or Patty Santana at pmoraes@health.ucsd.edu directly

Please note: overtime charges may apply when staff assistance is needed outside of regular business hours.

The CCR is developing a Standard Operating Procedure (SOP) for Daily Lab Operations. Once finalized, it will be posted on the ACTRI website.

 

Participant Experience Survey is Active

Patient Experience survey flyer

The CCR Participant Experience Survey is now available in clinic spaces. Please encourage participants to complete the brief survey during or after their visit. Feedback helps inform quality improvement and service enhancements.

 

New Process: Out-of-Town Participant Notification

To support visit planning and coordination, Clinical Research Coordinators (CRCs) are asked to notify the clinic when scheduling participants traveling more than 4 hours (drive time). When scheduling in Clinical Conductor, please include the following in the comments section: “Patient is traveling from out of town.” (Example screenshot included below.)

 

Visit Cancellation Tracking Update

A standardized process for documenting visit cancellation reasons has been implemented in Clinical Conductor. When cancelling a visit, please select the appropriate reason to support operational monitoring and improvement efforts.

Since implementation in November 2025, CCR has observed a 64% reduction in cancelled visits. See the accompanying graph for a breakdown of cancellations by initiating party.

Note that when visits are cancelled by clinic staff it is usually due to missing orders, and when visits are cancelled by clinic management it is due to staff or room availability.

CCR STAFF UPDATES

 

Please join us in welcoming new CCR team members:

  • Chandelle Butterfield, RN
  • Dionne Robinson, Laboratory Technician
  • Joyceline Lopez, Clinical Research Coordinator 

UPCOMING EVENT

 

Principal Investigator Town Hall

Date: March 25, 2026, 12-1PM
Location: via Zoom
Principal Investigators are invited to join CCR leadership for operational updates and open discussion. This forum provides an opportunity to share feedback and discuss priorities impacting clinical research support services.

If you would like to join this town hall and you have not yet received an invitation please email Amy Westermann at a2westermann@health.ucsd.edu.

CCR CLINIC REMINDERS

 
  • Submit nursing visit orders and central lab kits at least 48 hours prior to the scheduled study visit or there is a possibility your visit may be cancelled.
  • Remove any tape applied during visits from exam room floors before departure.  
  • Storage space in the La Jolla Main Clinic is limited. For storage-related questions, please contact the Clinic Manager Bernadette Cale at bcale@health.ucsd.edu.
  • The workstations at the nurses’ station are designated personal work areas and may contain staff belongings as well as participant records for various studies. To maintain privacy, security, and consistency, these spaces must remain reserved for assigned staff. We kindly ask that study team members refrain from sitting in this area to help protect participant privacy and respect individual workstations.
  • The clinic will have their Annual Skills day on Monday, April 27th and will not being providing clinical services. The clinic will, however, allow room-only visits on this day. Clinical Conductor is closed for April 27th, so please submit a Clinic Appointment Request Form for any room-only visits on this day. 

NEW CTSS SERVICE!

 

Clinical Trial Invoicing

The Clinical Trial Support Service (CTSS) team works closely with investigators and research teams who require additional support to invoice industry sponsors of clinical trials. This service streamlines the financial management of industry sponsored clinical trials by managing invoicing, tracking payment, and providing financial oversight from study activation to closeout.   

Service includes: 

  • Review the fully executed Clinical Trial Agreement (CTA)
  • Collaborate with study teams to identify invoiceable items 
  • Create and send invoice to sponsor 
  • Review financial report to confirm check is deposited 
  • Review and claim unapplied/unidentified checks 
  • Assist with billing dispute resolution in collaboration with Accounts Receivable team 
  • Reconcile study billing account and create final invoice at study closeout  

Investigators are encouraged to submit a request for clinical trial invoicing during study start up. However, retrospective financial review of a study will be considered on a case by case basis. 

For more detailed information or to discuss how we can assist you, please contact us at  actri-ctss@health.ucsd.edu. 

Center for Clinical Research (CCR) Units

 

The ACTRI Clinics

Contact for more information: ctri-clinic@health.ucsd.edu

 

Clinical Trial Support Services (CTSS)

Contact for more information:  actri-ctss@health.ucsd.edu

 

Clinical Research Coordinators (CRC)

Contact for more information: actri-coordservices@health.ucsd.edu

 
Learn More About CCR

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