Page 447 - eBook Version 8 Book 1 of 2 JUL 2022

Levels of Reporting
July 24, 2020
Overview of Safety Reporting:
1. Definitions of Key Terms
2. Research Reporting
a. FDA
b. Sponsor
c. Regulatory Agencies d. Institution
3. Non-Research Reporting
TERM
Purpose: To describe the process of fulfilling the responsibility; 1) to the safety and well-being of our participants and to the quality of research, and 2) patientcareat Children’sMedicalCenter according to the governing regulations and policies.
MEANING
SOURCE
Adverse Event (AE)
An AE is any untoward or undesirable experience associated with the use of a medical
product/test article/procedure in clinical research.
CH 7.44
Serious Adverse Event (SAE)
Any AE that results in any of the following outcomes: • Death
• Life-threatening situation
• Inpatient hospitalization or prolongation thereof
• Persistent or significant disability/incapacity • A congenital anomaly/birth defect
CH 7.44
Disability
A substantial disruption of a person’s ability to conduct normal life functions.
CH 7.44
Associated with the Use of the Drug or Device
There is a reasonable possibility that the experience may have been caused by the drug or device. Determined by the PI.
CH 7.44
Unanticipated Problem:
Any incident, experience, or outcome that is unexpected, r elated to the research, or puts the research subjects or others at greater risk.
CH 7.44
Sentinel Event
CH 2.12
Unusual Incident
An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof, to a recipient of care at Children’s Health System.
Any incident that is not consistent with the routine operation of the institution, or the routine care of a patient, regardless of whether or not there was an apparent injury or other damage.
CH 2.12
Incident
An expected or unexpected event that occurs in the course of performing duties or rendering services and may involve patients/clients, employees, visitors, equipment, or property. Non-serious incidents include minor injuries, accidents or falls that do not require medical attention.
CHHome Care Division
Serious Event
An adverse or sentinel event and is defined as an unexpected occurrence involving serious physical or psychological injury, or the risk thereof, including a temporary or permanent loss of limb or function.
CHHome Care Division
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