Adverse Event Reporting Flashcards
What guidance does adverse events reporting follow closely?
Good Clinical Practice (GCP)
Where are Adverse Events recorded?
Case Reporting Form (CRF)
If the case reporting form is electronic or web based, what is it called?
eCRF
What are the 5 main points which are reported?
- Start and end date of event
- Seriousness
- Severity
- Casuality // Relationship to Investigational Medicinal Product (IMP)
- Outcome
When is an adverse event considered serious?
When it meets the ‘Serious Adverse Events’ criteria.
What is the criteria for ‘Serious Adverse Events’?
Death
Life - Threatening
Hospitalisation
What does severity relate to?
Relates to the event intensity.
What do some trials use in order to standardise the definition of severity?
Common Terminology Criteria.
What is time limit to report a serious adverse event -> in regards to the investigator //designee knowing?
24 hours.
Who does the sponsor report to, if necessary?
MHRA
Ethics Committee
What are the number of grades used to measure the severity of adverse events?
5 grades.
What are the 5 grades used to measure the severity?
Grade 1 = Mild; asymptomatic or mild symptoms.
Grade 2 = Moderate; minimal, local or noninvasive intervention indicated.
Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization.
Grade 4 = Life-threatening consequences; urgent intervention indicated
Grade 5 = Death related to AE
What does causality mean?
Questions whether the adverse event was related to the IMP or were there are other causes?
What does outcome mean?
Has the patient recovered or not?
