NOHSP Definitions - S

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.

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Safety Reports: Sponsor-generated reports of serious and unexpected adverse events, occurring at any participating site, that are distributed to investigators at all participating sites. (HSP#067)

Scientific Member: An IRB member with the training, background and / or occupation to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline. The term “scientific” in this definition is based on the regulatory requirement for IRB membership. Scientific members will have varying levels of scientific expertise that must be taken into account when assigning review. Examples of scientific members include: Ph.D.s, physicians, nurses, pharmacists, other health professionals and research personnel such as analysts and statisticians. (HSP#009)

Serious Adverse Events (SAE): An AE that results in:

• Death
• A life-threatening experience, e.g., the individual was placed at immediate risk of death from the event.
• Inpatient hospitalization or prolongation of existing hospitalization.
• Persistent or significant disability/incapacity defined as a substantial disruption of a persons ability to conduct normal life functions.
• A congenital anomaly/birth defect.
• A medically important condition that, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the above outcomes. (HSP#067)

Serious Noncompliance: Incidents of noncompliance the have the potential to increase risks to participants or others, violate the rights of study participants, physically harm or otherwise injure participants or others, or adversely affect the scientific integrity of the protocol. Examples of serious noncompliance are: conducting research without IRB approval, failure to report serious adverse events, failure to obtain IRB approval prior to implementation of a change in the research, research conducted without IRB approval, failure to provide IRB requested information and failure to obtain informed consent from the participant. (HSP-058)

Severely Debilitating: Diseases or conditions that cause major irreversible morbidity. E.g. blindness, loss of limb, loss of hearing, paralysis, stroke. (HSP#034)

Short Form: A written document, in a language understandable by the participant or their legal representative, stating that the required elements of informed consent have been presented to and understood by the participant or the participant’s legally authorized representative. (HSP-065)

Significant Risk Device: A medical device that meets any of the following criteria:

• Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; or
• Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; or
• Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. (HSP-075)

See: Non-significant risk device.

Source Documents: Original documents and records including, but not limited to, hospital records, clinical and office charts, laboratory notes, memoranda, subjects diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiche, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial. (HSP#046)

Sponsor: A person or other entity that initiates but does not actually conduct the investigation. An entity other than an individual (e.g., a corporation or an agency) which uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor, not a sponsor-investigator, and the employees are considered to be investigators. (HSP-047)

Standard of care: Procedures that research participants would receive for the treatment of their disease or condition even if not participating in the research. (HSP#024)

Study Coordinator: The individual responsible for management of the daily activities of the study, including coordinating the treatment or testing of participants. (HSP#001)

Study Monitor: An individual employed by a commercial research sponsor to monitor the conduct of a study. This individual may be charged with periodic monitoring of study data and adverse event reports in order to assure the protection of study participants. (HSP#022)

Suspension of IRB approval of research: Temporarily or permanently withdrawing approval for some or all research procedures. (Suspended research remains “open” and subject to continuing review requirements.) (HSP#084) See ‘Termination’.