CCRC Module 4: Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety. Exam Questions With Correct Answers.

CCRC Module 4: Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety. Exam Questions With Correct Answers. Purpose of this ICH guideline is to harmonize the way to gather and take action on important clinical safety information that arises during clinical development. - answerE2A Methods of safety reporting are different in pre- and post-marketing phases, but it is critical to remember that the processes can be __. - answerInterdependent Describe ICH E2A: - answer1. Harmonize the way to gather and take action of safety information during clinical development. 2. Covers all phases of clinical development 3. Used in conjunction with GCP. 4. Covers safety reporting. ICH E2A was developed to do two things to improve clinical safety data management: - answer1. Provides standard definitions and terms for key aspects of clinical safety reporting. 2. Creates appropriate ways for handling expedited safety reporting during the investigation or pre-approval phase. In clinical studies, __is the most important aspect of the reporting process. - answerconsistency List the key safety reporting terms in ICH E2A: - answer1. ADR 2. AE 3. SAE 4. Unexpected ADR 5. Serious ADR EXAM STUDY MATERIALS July 29, 2024 12:59 PM Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment - answerAdverse event This safety reporting does not have to be directly related to the use of the medicinal product, but must be related to the administration of the product. - answerAE For safety reporting: The ICH definition sets the minimum ___, and the trial protocol specifies the ___. - answerThe ICH definition sets the minimum standard, and the trial protocol specifies the timing. This analysis will include information on anyone who was intended to have the product administered, whether it actually happened or not. - answerSafety analysis/intention to treat analysis - more commonly used, includes subjects that received at least 1 dose of trial meds. For this analysis, only the information for subjects who have taken the product will be included in the analysis. - answerPer-protocol analysis For this phase, an ADR is: any adverse event that is reasonably related to use of a medicinal product. If an adverse event is possibly, probably, or definitely related to use of a medicinal product, it's an ADR. - answerPre approval For this phase, an ADR is: any unintended response to a medicinal product. - answerMarketed products · Even if an event is severe, it may not be_____and may not require ____ ___. - answer· Even if an event is severe, it may not be serious and may not require expedited reporting. How is the severity of the event classified? - answerMild, moderate, severe This severity is one that subject is aware of but does not impact normal daily activities - answerMild This severity is one that subject is aware of, but it hinders, but does not PREVENT, normal daily activities - answerModerate This severity is one that prevents the performance of normal daily activities - answerSevere ____ is based on the patient or event outcome, usually posing a threat to a patient's life or ability to function. - answerSeriousness ___ serves as a guide for determining expedited reporting requirements. - answerSeriousness EXAM STUDY MATERIALS July 29, 2024 12:59 PM · In order to comply with the expedited reporting requirements of the E2A guideline, you must be able to identify whether or not an AE is___. - answerserious The medical determination on the seriousness of an AE is a responsibility of the: - answerqualified physician, PI, or sub-PI An AE is serious if it results in one of these 6 things: - answer1. Death 2. Prolonged hospitalization, or inpatient hospitalization 3. Birth defect/anomaly 4. Disability/incapacity. 5. Life threatening 6. Important medical event Should death be reported as the SAE? - answ