SOCRA CCRP Exam 2022 Review with Comprehensive Solutions | Latest 2023/2024

SOCRA CCRP Exam 2022 Review with Comprehensive Solutions | Latest 2023/2024 SAE ️ Serious Adverse Event: - results in death - is life threatening (patient was at risk of death at time of the event) - results in persistent or significant disability - congenital anomaly/birth defect Short Form ️ A document that states that the elements of informed consent have been presented orally to and understood by the participant or the participant's LAR. 4 components of short form ️ 1. A short form consent document 2. And oral presentation of the required elements of consent 3. An awesome rob approved written summary of what is to be said 4. A witness must be present Number of days the Sponsor has to report and SAE to the FDA ️ 15 calendar days (IND Safety Report) - FDA Form 3500A or CIOMS I Form (for foreign suspected adverse reactions) Medical devices 1572? ️ No. Investigator agreement instead. UADE ️ Unexpected Adverse Device Effect. Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety or welfare of subjects. Days the investigator has to report UADE to the sponsor ️ 10 working days Days the sponsor has to report UADE to FDA and IRB ️ 10 working days Days investigator has to report SAE to sponsor ️ Immediately