Clinical & Translational Research Unit

The CTRU supports clinical research for Adult studies (non-cancer and cancer) and Child Health Studies.

Clinical Space for Adult Studies

The CTRU utilizes space at the Freidenrich Center for Clinical and Translational Research at 800 Welch Road, along with in-patient bed capabilities at both hospitals.

Clinical Space for Child Health Studies

The CTRU Child Health Component utilizes beds at Lucile Packard Children's Hospital for its inpatient activities. The facilities of the premature infant research program of the CTRU consist of the intensive care nursery and the intermediate intensive care nursery.

To Use the CTRU:

• Enter project into Study Navigator and click “submit study” on the last intake page (the system will then open the Study Overview page)
• On the Study Overview page, scroll down and click on “CTRU Facilities”
• Under “Next Steps” click on “Complete CTRU Request Form”
  (the link is located in CTRU Facilities tab under the “Design Study” tab on the Overview page)
• Complete the CTRU Request form and click “Submit CTRU Request” at the bottom of the page
• Once Request Form is submitted, an email will be sent to the CTRU staff and to your assigned Study Facilitator
• A pop-up box will now appear with a link to the CTRU Budget Planner. Click on this link to download the tool (this is an excel document)
• The first tab in the excel document is instructions for completing the tool. After reviewing the instructions, click on the tab labeled “CTRU Budget Planner” and complete the worksheet
• After completing the Budget Planner, save and then upload to the Documents tab of the Overview page in Study Navigator

Key Points

• An approved CTRU Request Form is required in order to utilize any CTRU service or resource.

When is a CTRU Request Form required?

If you are conducting a study and would like to use any of the participant interaction resources or the clinical lab for sample processing, you must complete a CTRU Request Form through Study Navigator. This is required for all:

• Adult Studies
• Child Health Studies
• Cancer Protocols to be Performed at the CTRU
• CTRU services at the 1070 Arastradero Road Research Clinic (research sample acquisition and processing)

Reminder: Investigators must submit a revision to the IRB prior to initiating any modification to the original protocol. This includes changes in treatment plan, patient eligibility requirements, or exclusion criteria.

Protocol Review

Protocol applications are reviewed for CTRU resource utilization by CTRU staff — administration, nursing, laboratory, dietary. The Chair of the Scientific Review Committee (SRC) will determine if a scientific review is required.

Scientific Review

Stanford faculty-initiated studies that have not had other peer review will be assigned for medical/scientific review by the SRC Chair.

Requests that require Scientific Review must be received a minimum of three weeks prior to the Committee's scheduled meeting. (SRC Committee meets the 4th Tuesday of each month.)

The SRC reviewer will transmit questions and comments to the P.I. of the proposed study, and will recommend one of the following actions to be voted on by the SRC:

• Approve
• Approve contingent on response by P.I.
• Disapprove
• Defer pending major revisions or other considerations

Note: The CTRU Advisory Committee requires the PI or his/her responsible, knowledgeable representative to attend the committee review meeting. The CTRU will contact both the PI and the contact person named in the application on the Monday prior to the Advisory Committee review meeting. If a member of the study team does not attend the meeting and questions remain unanswered, the protocol will be deferred to the following month.

Scientific Review Exemptions

The following protocols are exempt from medical scientific review by the SRC:

• Cancer protocols, reviewed by the Scientific Review Committee of the Cancer Center
• Studies which have been peer-reviewed via NIH or non-profit foundation grants
• Industry sponsored trials

Cancer Center Studies Protocol Review

Cancer Center Studies require the same CTRU Request Form as non-cancer studies. In addition to completing the Request Form, you must also apply for review by the Cancer Clinical Trials Office (CCTO) Scientific Review Committee (SRC).

Following Approval of Request Form

• Call the CTRU Nurse Manager at 723-6973 to arrange an in-service for the CTRU staff prior to patient admission.

Key Points

• A CTRU Request Form is required for all CTRU services and resources.
• Submit your completed CTRU Request Form at least three weeks prior to scheduled Scientific Review Committee Meetings.

CTRU research nurses provide outpatient research interventions to adult and child research participants enrolled in CTRU trials. CTRU research nurses are highly skilled in techniques including:

• Administration of investigational drugs
• Chemotherapy administration (related to research)
• Complex specimen collection
• Central line access
• Electrocardiograms
• Pharmacokinetic blood sampling
• Venipuncture

Key Points

• An approved CTRU Request Form is required for all CTRU services and resources.

CTRU Laboratories have been structured to provide optimal service to all CTRU investigators. The equipment and space are used exclusively for CTRU activities. Currently, there are two physical CTRU laboratory locations. Laboratories are located at:

• Freidenrich Center for Clinical and Translational Research at 800 Welch Road, FC 145
  (effective 8/5/2012)
• Cancer Center (room CC-2341)

Laboratory Functions

The primary functions of the CTRU laboratory are:

• processing of clinical research specimens
• the performance of specialized research tests
• shipping and receiving of biological and dangerous specimens
• Staff are also available to assist with phlebotomy.
• provide sample acquisition and processing support for studies that have to be done in Stanford Hospital (inpatient or outpatient)

HIMC LAB

The Human Immune Monitoring Center (HIMC) is a comprehensive source for immune monitoring services for clinical and translational studies. HIMC provides standardized, specimen processing and state-of-the art immune monitoring assays at the RNA, protein, and cellular level. In its partnership with CTRU, HIMC handles all PBMC isolation for SOM. For more information, please visit HIMC.

The overall utilization of laboratory resources is balanced among investigators and reflects differences in census and intensity of sampling among various protocols.

We meet with individual investigators or their staff to establish the coverage requirements and will work closely with nursing staff to implement the procedures for collecting and processing of samples according to given procedures, some days continuously around the clock to accommodate biological samples generated.

Confidentiality Issues

All laboratory personnel are HIPAA certified and follow HIPAA regulations for confidentiality issues. To comply with National Bioethics Advisory Commission’s recommendations, all samples that are processed by a CTRU laboratory are coded to ensure that the privacy and interests of research subjects are protected. The laboratory then provides the investigator with a database to identify the coded samples. CTRU laboratories use a bar-coded sample tracking system to help with the inventory and management of these coded samples.

Key Points

• A completed CTRU Request Form is required for all CTRU services and resources.
• CTRU laboratory is NOT CLIA certified. Test results should not be used to make medical diagnostic or treatment decisions.

CTRU Bionutrition and Dietary services include:

• Budget Consultation — Estimation of protocol-specific costs for bionutrition services including nutrition counseling, research diet preparation, labor, food, and supplies.
• Research Diets — Work with investigators to design study-specific menus for nutrient-controlled research protocols.
• Meal Preparation and Service — Preparation of research diets, weighed to the nearest 0.1 gram, for study participants including controlled research meals, and post-test snacks or meals.
• Nutritional Counseling — Design of protocol-specific diet instructions for study participants.
• Dietary Recalls and Dietary Records — Administration, review, entry, and analysis of dietary records.
• Nutritional Analysis — Computerized analysis of dietary intake using state of the art software.
• Oversight of Subject Randomization and/or Blinding for Dietary Protocols — Tracking of subject randomization codes and administration of blinded dietary treatments.

Key Points

• A completed CTRU Request Form is required for all CTRU services and resources.

Spectrum mentoring efforts are intended to support the career development of junior investigators and other trainees. 

Spectrum Child Health has a well-developed mentoring program for child health investigators. Additional efforts are in early development stages, and ultimately will include a Council of Mentors for junior investigators.

The Clinical and Translational Research Unit (CTRU)* is the major clinical research facility for Stanford University School of Medicine. It provides an optimal facility for the conduct of patient-oriented research, to translate basic scientific knowledge into a better understanding and treatment of human diseases, and to train health professionals in clinical research.

Stanford investigators with IRB-approved active adult and child health protocols may utilize CTRU facilities and services.

The CTRU supports studies (including cancer studies) that are conducted in the:

• Stanford Hospital & Clinics (main hospital)
• Veterans Affairs Palo Alto Health Care System
• Lucile Packard Children's Hospital

Services include:

• in- and outpatient clinical space
• research nursing services
• clinical laboratory services
• bionutrition services

* The CTRU was formerly the General Clinical Research Center (GCRC).

The CTRU was formerly the General Clinical Research Center (GCRC). The Stanford GCRC was founded in 1962 and has been in continuous operation since then.  Branimir I. (Brandy) Sikic, MD, was program director of the GCRC from 1993 to 2008, and with the transition to the Spectrum grant in 2008, became the Director of the CTRU.

A separate Pediatric GCRC, originally designated for research on prematurity (The Premature Research Center), was opened in 1962, and in 1993 this unit was combined with the main GCRC. At that time, the Program Director of the Pediatric GCRC, David K. Stevenson, MD became the Associate Program Director of the Stanford GCRC. Dr. Stevenson expanded the Pediatric Component to include all other Pediatric Clinical Translational Research (CTR).

The CTRU currently supports 170 active protocols studying:

• new therapies for cancers
• insulin resistance and its relationship to type-2 diabetes and cardiovascular disease (CVD)
• cure of Hodgkin’s disease and non-Hodgkin’s lymphomas
• psychotic depression
• other diseases
• studies involving nutrition and therapeutic compliance.

The number of principal investigators involved in CTRU studies has grown to over 70, distributed among three University Schools, and 18 separate departments and divisions.

The CTRU has supported many important clinical research accomplishments and many significant medical advances.  Accomplishments include:

• Studies of drug resistance in cancer therapies
• Advances in the cure of Hodgkin’s disease and non-Hodgkin’s lymphomas
• Cardiac transplantation
• Dyslipidemias and glucose homeostasis
• Monoclonal antibody therapies
• Noninvasive detection of bilirubin production
• Noninvasive imaging of tissue structure and function
• Antiviral therapy
• Pediatrics - Infectious Diseases

The CTRU Director, Branimir I. (Brandy) Sikic, M.D., is directly responsible for the conduct of the inpatient and outpatient clinical investigation.

He, in turn, is responsible to the Principal Investigator, Harry B. Greenberg, M.D., Director, Spectrum, Senior Associate Dean, Research and Training and the Joseph D. Grant Professor in the School of Medicine.

The Advisory Committee meets on a monthly basis and has, as its primary function, consideration of the quality of the clinical research being performed on the CTRU. In addition, it considers general policies, common needs, resource allocations, patient admission policies, and fiscal and administrative matters. In its advisory capacity, once a consensus has been reached, the administrative officers of the CTRU act as agents for implementing the intent of the Committee.

CTRU Scientific Review Panel

• Fahim Abbasi, MD
• Ranjana Advani, MD
• Joseph K. Belanoff, MD
• Cornelia Dekker, MD
• Bradley Efron, PhD
• Mark Genovese, MD
• Phil Lavori, PhD
• Tracey McLaughlin, MD
• Natalie Rasgon, MD — Chair
• Lawrence Recht, MD
• Darrell Wilson, MD
• Bill Robinson, MD
• Andy Hoffman, MD
• Geoff Gurtner, MD
• Krisa van Meurs, MD
• Jason Gotlib, MD
• Steve Alexander, MD

Ex Officio

• Branimir I. Sikic, MD – Program Director
• David K. Stevenson, MD – Associate Program Director

CTRU Policy and Oversight Committee

• Brandy Sikic, MD – Co-Chair
• David Stevenson, MD – Co-Chair
• Bill Robinson, MD
• Andy Hoffman, MD
• Geoff Gurtner, MD
• Natalie Rasgon, MD — Chair
• Jason Gotlib, MD
• Krisa van Meurs, MD
• Steve Alexander, MD
• Martha Kessler (ad-hoc)
• Steve Goodman, MD, PhD

Boilerplate text describing the FCTR (Freidenrich Center for Translational Research), and the CTRU facilities in the new FCTR space is available for use in your grant proposals. Download this Word document that can be used in your documents (e.g., grant proposals); it can be edited as necessary to fit your needs. Check the date of boilerplate text to ascertain that it is current for your needs.