Helpful Information for the New Study CAFÉ Application

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Contact Us

Office of Regulatory Compliance

Maggie Lindenbaum
Director, Clinical Research Support Services
424-440-0438

Allan Derrick Udarbe
Manager, Office of Regulatory Compliance
Text/Call: 424-440-0163

Madelene Chaaban
Compliance Officer, Office of Regulatory Compliance
310-923-1011

Colleen Mathis
Compliance Officer
310-295-7681

Clinical Oncology Research Administration (CORA)

Maggie Lindenbaum
Director, Clinical Research Support Services
424-440-0438

Marsha Noeline
Disease Site Group Program Manager
310-810-4956

Gina Santisaranyu
ISPRC Specialist
310-853-5845

Jorge Huezo
DSMB Specialist
310-730-8509

Mark Glover
Reporting and CT.gov Registration Coordinator
310-602-6831

Quality Performance and Education (QPE) — Clinical Research Training

Maggie Lindenbaum
Director, Clinical Research Support Services
424-440-0438

Gina Hawkins
Quality, Performance and Training Coordinator
Teams: gthawkins
Email: [email protected]

Sponsor Type

National

  1. NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks
    • NRG
    • COG
    • GOG
    • SWOG
    • ECOG-ACRIN
    • Adult Brain Tumor Consortium (ABTC)
    • AIDS Malignancy Consortium (AMC)
    • Blood and Marrow Transplant Clinical Trials Network (BMTCTN)
    • Cancer Immunotherapy Trial Network (CITN)
    • COG Phase I Consortium (COGC):
      • New Approaches to Brain Tumor Therapy Consortium (NABTT)—when the trial is not Rostered.
      • New Approaches to Neuroblastoma Treatment (NANT)—when the trial is not Rostered.
      • North American Brain Tumor Consortium (NABTC)—when the trial is not Rostered.
      • Pediatric Brain Tumor Consortium (PBTC)
  2. All NCTN, ETCTN, NCORP, and CCOP trials are categorized as “National”

R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism supported by the NIH or organizations on this list: Organizations with Peer Review Funding Systems.

  • Agency for Healthcare Research and Quality (AHRQ)
  • Alex’s Lemonade Stand Foundation (ALSF)
  • American Association of Cancer Research (AACR)
  • American Cancer Society (ACS), (national office only)
  • American Foundation for AIDS Research (amfAR)
  • American Institute for Cancer Research (AICR)
  • California Institute for Regenerative Medicine (CIRM)
  • Cancer Prevention Research Institute of Texas (CPRIT)
  • Center for Disease Control and Prevention (CDC)
  • Central Office of the Veterans Administration (VA), (excluding local/regional and “block” grants)
  • Environmental Protection Agency (EPA)
  • The Flight Attendant Medical Research Institute (FAMRI)
  • Florida Biomedical Research Program (FBRP)
  • Food and Drug Administration (FDA)
  • Howard Hughes Medical Institute (HHMI)
  • Leukemia and Lymphoma Society (LLS)
  • Melanoma Research Alliance (MRA)
  • Multiple Myeloma Research Foundation (MMRF)
  • National Institute for Occupational Safety and Health (NIOSH)
  • National Science Foundation (NSF)
  • New York State Department of Health Wadsworth Center/New York State Stem Cell Science Program (NYSTEM)
  • Patient-Centered Outcomes Research Institute (PCORI)
  • Prevent Cancer Foundation (PCF)
  • Prostate Cancer Foundation (PCF)
  • Susan G. Komen for the Cure
  • The California Breast Cancer Research Program (CBCRP)
  • The California Tobacco Related Disease Research Program (TRDRP)
  • U.S. Army (DOD) special research programs - Grants funded through the U.S. Army’s, (DOD) special research programs in ovarian, breast and prostate cancer may also be listed in the category of peer reviewed funded grants

Institutional

In-house clinical research studies authored or co-authored by Cancer Center investigators and undergoing scientific peer review solely by the Protocol Review and Monitoring System of the Cancer Center. The Cancer Center investigator has primary responsibility for conceptualizing, designing, and implementing the clinical research study and reporting results.

  • It is acceptable for industry and other entities to provide support (e.g., drug, device, other funding), but the trial should clearly be the intellectual product of the center investigator
  • This category may also include:
  • Institutional studies authored and implemented by investigators at another Center in which your Center is participating
  • Multi-Institutional studies authored and implemented by investigators at your Center (Note: National and externally peer-reviewed studies should be listed with those categories, not as Institutional studies)

Industrial

A pharmaceutical company controls the design and implementation of these clinical research studies

Protocol Type

Basic Science (BAS)

Protocol designed to examine the basic mechanisms of action (e.g., physiology, biomechanics) of an intervention.

Diagnostic (DIA)

Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition. (ICD codes.)

Health Services Research (HSR)

Protocol designed to evaluate the delivery, processes, management, organization, or financing of health care.

Prevention (PRE)

Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.

Screening (SCR)

Protocol designed to assess or examine methods of identifying a condition (or risk factor for a condition) in people who are not yet known to have the condition (or risk factor).

Supportive Care (SUP)

Protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects, or mitigate against a decline in the participant’s health or function. In general, supportive care interventions are not intended to cure a disease.

Treatment (TRE)

Protocol designed to evaluate one or more interventions for treating a disease, syndrome, or condition. Note: This equates to therapeutic trials in previous versions of the guidelines.

Other (OTH)

Not in other categories

Data Table 4 Report Type

Interventional

Individuals are assigned prospectively by an investigator based on a protocol to receive specific interventions. The participants may receive diagnostic, treatment, behavioral, or other types of interventions. The assignment of the intervention may or may not be random. The participants are followed and biomedical and/or health outcomes are assessed. 

Observational (non-interventional)

Studies that focus on cancer patients and healthy populations and involve no prospective intervention or alteration in the status of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants. The participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the study. 

Ancillary or Correlative: (non-interventional)

  • Ancillary: Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study. Only studies that can be linked to individual patient or participant data should be reported. 
  • Correlative: Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Only studies that can be linked to individual patient or participant data should be reported.