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Protocol Submission Sheet Definitions
- Cooperative: recognized by NCI; includes ACRIN, ACOSOG, AMC, CALGB, COG, CTSU, ECOG, EORTC, GOG, NCCTG, NCIC CTG, NSABP, RTOG, SWOG.
- Industrial Trials: Design and implementation of the study is controlled by the pharmaceutical company.
- Externally Peer-Reviewed Trials: R01s and P01s or other trial mechanisms funded by NIH or supported by other peer-reviewed funding organizations, such as the ACS, the Komen Foundation, etc.
- Institutional Trials: In-house, internally reviewed trials, including those collaborative studies conducted with industry sponsorship in which the center is a primary contributor to the design, implementation, and monitoring of the trial, or participation in a multi-site trial initiated by an institutional investigator at another center.
- Therapeutic intervention (The): Clinical trials with therapeutic intent using drugs, radiation, surgery, other biological agents or behavioral or other interventions.
- Prevention intervention (Pre): Clinical trials for the modulation of cancer risk and inhibition of cancer progression using chemoprevention drugs, nutritional, dietary, behavioral, or other interventions.
- Non-Intervention studies: Ancillary or Correlative studies must be linkable to other patient data.
- Screening, Early Detection, or Diagnostic (Scr, Det, Dia): Clinical trials directly testing the efficacy of devices, techniques, procedures; or tests for earlier/more accurate detection or diagnosis of disease
- Supportive Care/Symptom Management/Behavioral (Sup): Clinical trials intended to improve the comfort and quality of life for the patient using drugs, nutritional, dietary, behavioral or other interventions.
- Epidemiologic/Observational/Outcome (Epi,Obs,Out): 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 and behavioral studies, etc.
- Ancillary (Anc): Auxiliary studies that are stimulated by, but 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 included must be linked to an active trial, or epidemiologic or other study and should include only patients accrued to that trial or study. Only studies that can be linked to individual patient or participant data should be reported.
- Correlative (Cor): 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.
- Other: Includes non-intervention Behavorial studies, Registry and Tissue Repository protocols.
