If a Research Related Injury (RRI) is suspected, the Principal Investigator (PI), or delegated co-investigator, will make the initial determination as to whether or not the event meets the definition of research related injury. If there is a belief that this is a research related injury the PI will then contact the UCD Director of Clinical Research Administration Office (CRAO) and the UCHealth System Director of Research Administration to inform them that the PI intends to notify the sponsor of this determination. Reporting of the AE must be done in accordance with the contract and IRB of record policies/procedures and should not be delayed for this process. Encounters for RRI should not be linked as they have their own mechanism.

Research Related Subject Injury is defined as a medical condition which is caused by and/or directly related to the research study. That is, the condition would not have existed but for the subject’s participation in the study and which is in need of diagnosis and treatment as a matter of medical necessity.

Given the nature of clinical trials, generally excluded under the definition of research related subject injury would be:

• The event under review is attributable to the subject’s underlying medical condition
• The event was caused by the researcher or other member of the team
• The event was caused by non-research related activities

If a Research Related Injury (RRI) is suspected, the Principal Investigator (PI), or delegated co-investigator, will make the initial determination as to whether or not the event meets the definition of research related injury. If there is a belief that this is a research related injury the PI will then contact the UCD Director of Clinical Research Administration Office (CRAO) and the UCHealth System Director of Research Administration to inform them that the PI intends to notify the sponsor of this determination. Reporting of the AE must be done in accordance with the contract and IRB of record policies/procedures and should not be delayed for this process. Encounters for RRI should not be linked as they have their own mechanism.

Research Related Subject Injury is defined as a medical condition which is caused by and/or directly related to the research study. That is, the condition would not have existed but for the subject’s participation in the study and which is in need of diagnosis and treatment as a matter of medical necessity.

Given the nature of clinical trials, generally excluded under the definition of research related subject injury would be:

• The event under review is attributable to the subject’s underlying medical condition
• The event was caused by the researcher or other member of the team
• The event was caused by non-research related activities