NOHSP Definitions - O

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

O

Observational Research: A research study that does not involve an intervention or alteration in standard clinical care. Research registries, retrospective research, and research using existing data or samples, are considered ‘observational’ for reporting purposes. (HSP#067)

Official Correspondence: Written communication between the PI and the IRB Chair, or designee, regarding IRB determinations or activities.

Correspondence that is sent by the IRB Coordinator according to IRB policy and that requires action on the part of the PI is also considered official correspondence, e.g., continuing review notices, training reminders, requests for additional information, review requirements.
Reports of potential investigator noncompliance or misconduct, or participant complaints, are considered official correspondence. (HSP#036)

Off-Label use: Use of a drug, biologic, or device for an indication not in the FDA approved labeling according to a physicians best knowledge and judgment concerning good medical practice and an individual patients best interest. (HSP-075)

Oversight: Active supervision, by the Principal Investigator, of all aspects of the implementation of an approved research study. The PI’s oversight of a research study may be accomplished through direct, hands-on, involvement in research procedures, or by staff meetings, and regular, documented, review of research records. (HSP#073)