OnCore: Protocol Type (Oncology)
Protocol Type is used for institutional reporting and will programmatically determine which studies trigger the Research banner/icon within Health Link for studies interfaced from OnCore. Studies that are considered 'Interventional' will trigger the Research banner/icon; which when clicked, takes the user to the Research Studies Activity that displays specific information about the study(s) in which the patient is participating (e.g., PI, IRB#, study title*).
*Note: a process is in place to mask titles for studies of a stigmatizing nature in the Research Studies Activity in Health Link, so selection of Protocol Type should not be influenced.
Additional information on the Research Studies Activity will be provided once implemented in Health Link.
Protocol Type |
Data Field Definition |
Health Link Category |
| Treatment |
Protocol designed to evaluate one or more interventions for treating a disease, syndrome, or condition. Note: this equates to therapeutic trials in previous version of the NCI CCSG guidelines. |
Interventional in Health Link, may not match OnCore DT4 type |
| Supportive Care |
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. |
Interventional in Health Link, may not match OnCore DT4 type |
| Prevention |
Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition. |
Interventional in Health Link, may not match OnCore DT4 type |
| Screening |
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). |
Observational in Health Link, may not match OnCore DT4 type |
| Diagnostic |
Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition. |
Observational in Health Link, may not match OnCore DT4 type |
| Health Services Research |
Protocol designed to evaluate the delivery, processes, management, organization, or financing of health care. |
Observational in Health Link, may not match OnCore DT4 type |
| Basic Science |
Protocol designed to examine the basic mechanisms of action (e.g., physiology, biomechanics) of an intervention. |
Observational in Health Link, may not match OnCore DT4 type |
| Extension (Rollover) |
Protocols that are extended under a new protocol that is the same as the initial protocol to provide treatment to patients who are benefiting from the treatment on the initial protocol. They are not technically “studies” because there is no research question/end point, however, they do go to PRMC for approval . Important Note: If the protocol has a research question/end point, e.g., studying efficacy, then the Protocol Type field should be “Treatment” (see above). Data Table 4 Report Type: “Not Applicable” is entered in the PC Console > Main > Data Table 4 Report Type field. |
Observational in Health Link, will not match OnCore DT4 type (N/A) |
| Compassionate Use / Expanded Access Protocol |
Data Table 4 Report Type: “Not Applicable” is entered in the PC Console > Main > Data Table 4 Report Type field. |
Observational in Health Link, will not match OnCore DT4 type (N/A) |
| Other |
Not in other categories. |
Observational in Health Link, will not match OnCore DT4 type (N/A) |
| Registry/Database |
Individual databases that collect data on subjects that meet a predetermined set of criteria with no specific research question. Does not meet with NCI definition of clinical research. For example, Head and Neck Database. Data Table 4 Report Type: “Not Applicable” is entered in the PC Console > Main > Data Table 4 Report Type field. |
Registry/Repository |
| Biospecimen Repository |
Protocols that involve the collection of biospecimens from cancer patients or healthy volunteers for use in ongoing lab studies or for preservation in a repository for future studies. Does not meet the NCI definition of clinical research. Data Table 4 Report Type: “Not Applicable” is entered in the PC Console > Main > Data Table 4 Report Type field. |
Registry/Repository |