Definitions of Research Compliance Terms

Safety Reports (IND/IDE) – Written reports from sponsors notifying the FDA and all participating investigators of any adverse experience associated with the use of a drug that is both serious and unexpected.

Serious Adverse Drug Experience – Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

Significant Risk Device – An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject.

Site Visit – Typically refers to a visit from a federal office to ensure the entity is complying with federal regulations.

Standard Operating Procedures (SOP) – Detailed written procedures for the uniform performance of a function. (Federal regulations tell “what” to do, but not “how” to do it. Individual institutions SOP outline the “how” to do research at that institution.)

Subjects – See “Human Subject.”

Surveys – Studies designed to obtain information from human subjects through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.

Suspension – Typically used in the context of a federal agency taking action against an institution. For example, the Office for Human Research Protections can suspend an Assurance, preventing the institution from continuing to conduct studies supported with federal funds.