Adverse drug reactions

Question 1

What guidance do trials follow when reporting adverse events?

Answer 1

Good clinical practice (GCP)

Question 2

Where are adverse events recorded?

Answer 2

Case reporting form (CRF)

Question 3

What is the case reporting form referred to in an electronic/web based form?

Answer 3

eCRF

Question 4

What are the 5 points that must be included in a report?

Answer 4

Start and end date of the event 
Seriousness 
Severity 
Causality/ relationship ti the investigational medicinal product (IMP)
Outcome

Question 5

When is an adverse event considered serious?

Answer 5

When it meets the ‘serious adverse events’ criteria

Question 6

What does severity relate to?

Answer 6

The events intensity

Question 7

What is the criteria for serious adverse events?

Answer 7

Death
Life treating
Hospitalisation

Question 8

What standardisation tool is used in some trials to standardise the definition of severity?

Answer 8

Common terminology criteria for adverse events (CTAE)

1= least severe 5=most severe

Question 9

When must serious adverse events be reported?

Answer 9

within 24 hours of knowledge of event

Question 10

If necessary, who must the sponsor report the SAE to?

Answer 10

MHRA

Ethics committee

Question 11

How many grades are there to measure the severity of the serious adverse event?

Answer 11

5 Grades

Question 12

What are the 5 grades?

Answer 12

Grade 1 - Mild, asymptomatic/mild symptoms
Grade 2 - moderate, minimal, local intervention indicated
Grade 3 - severe or medically significant but not life-threatening. Hospitalisation/disabling indicated
Grade 4 - life-threatening consequences, urgent intervention indicated
Grade 5 - Death related to the adverse event