Oncology:

Data Table 4 Report (Clinical Research Categories) Type is used by the NCI to classify different studies.

NCI Clinical Research definition:

Patient-orientated research: This type of research is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual, tissue banking, and studies that do not require patient consent (e.g., retrospective chart reviews). Patient-orientated research includes:

• • Studies of mechanisms of human disease
  • Studies of therapies or interventions for disease
  • Clinical trials, and 
  • Studies to develop new technology related to disease
• Epidemiological and behavioral studies: Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants, e.g., surveillance, risk assessment, outcome, environmental, behavioral studies.
• Health services research: Protocol designed to evaluate the delivery, processes, management, organization, or financing health care.

Non-oncology: Not applicable

Oncology: Required

Interventional: Clinical Research Category in which 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: Clinical Research Category in which the studies 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/Correlative: 

• Ancillary: Studies that re 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.

Not Applicable: protocols that should not be reported on the Data Table 4 Report because they do not meet the NCI definition of clinical research.

Do not change after PRMC approval without consulting with PRMC Coordinator.

Non-oncology: Not applicable

Yes

NCI Report field