UNC-Chapel Hill RTI International N.C. A&T

Funded by:  NIH | NCATS | CTSA

Protocol Categorization

Determination as to what extent a research project will be supported will be determined by the CTRC Oversight Committee.

A research protocol is designated as one of the following categories:

  • Category A Studies: Study initiated by a senior investigator** (NIH/Grant, Foundation, Network studies, Department sponsored, or unfunded research). This category of studies pays 50% of the CTRC level of care fee.
  • Category B Studies: Study initiated by an early stage investigator* (NIH/Grant, Foundation, Network studies, Department sponsored, or unfunded research). This category of studies pays 25% of the CTRC level of care fee.
  • Category D Studies: Study initiated by an investigator or industry and sponsored by industry. This category of studies pays 100% of the CTRC level of care fee.
*A principal investigator is considered an “Early Stage Investigator” if he/she is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).
**A principal investigator is considered a "senior investigator" if he/she completed his/her terminal research degree or medical residency (or the equivalent) more than 10 years ago. All associate and full professors are considered "senior investigators."

Investigator-initiated Protocols

Investigator-initiated studies are generally funded by a non-profit, state, or government agency; however in some cases, studies may also receive industry funding. For multi-center studies, UNC does not have to be the coordinating center; however; the research must meet ALL of the following criteria to receive a designation as an Investigator-initiated protocol:

  • The research is within the investigators’ area(s) of academic research interest.
  • The investigator(s) have had substantial input into protocol design for the proposed protocol and take responsibility for the quality of the protocol.
  • The principal investigator will have full control of the data and will be the responsible author for all major publications that result from the research.

Industry-Initiated Protocols

Industry-initiated studies are those in which an industry sponsor has approached an investigator to conduct a study where the protocol design was initiated by the sponsor and the investigator and study expenses are paid for by the industry sponsor.