ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting – E2A Guidelines (pages 281-294)​

Question 1

ICH Clinical Safety Data Management:​
Definitions and Standards for Expedited Reporting - E2A (page 279) was finalized in what year?

Answer 1

1994

Question 2

Adverse Event or Adverse Experience (AE) Definition

Answer 2

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

Question 3

Adverse Drug Reaction (ADR) definition

Answer 3

All noxious and unintended responses to a *medicinal product related to any dose should be considered adverse drug reactions.

Question 4

​Unexpected Adverse Drug Reaction (UADE) definition

Answer 4

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational *medicinal product)

Question 5

Serious Adverse Event or Adverse Drug Reaction (SAE) definition

Answer 5

A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose:​

• results in death,​
• is life-threatening,​
• requires inpatient hospitalization or prolongation of existing hospitalization,​
• results in persistent or significant disability/incapacity, or​
• is a congenital anomaly/birth defect.

Question 6

The MedWatch form, also known as

Answer 6

Form FDA 3500A, is used for mAndatory reporting of medical device adverse events by manufacturers, user facilities and importers.​

Question 7

Form FDA 3500,

Answer 7

a condensed version of 3500A (Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers.​), is used for VOLUNTARY reporting of adverse events by healthcare professionals, consumers and patients.

Question 8

______ is an adverse reaction, the nature or severity of which is not consistent with the applicable product information.​

​

A. Adverse Event or Adverse Experience (AE)​

​

B. Adverse Drug Reaction (ADR)​

​

C. Unexpected Adverse Drug Reaction (UADE)​

​

D. Serious Adverse Event (SAE)

Answer 8

C. Unexpected Adverse Drug Reaction (UADE)​

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational medicinal product)

Question 9

Which of the following is considered a Serious Adverse Event or Adverse Drug Reaction (SAE):​

results in death​

life-threatening​

hospitalization​

persistent or significant disability/incapacity​

congenital anomaly/birth defect​

All of the above ​

None of the above

Answer 9

All of the above​

Serious Adverse Event or Adverse Drug Reaction (SAE)​

A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose:​

• results in death,​
• is life-threatening,​
• requires inpatient hospitalisation or prolongation of existing hospitalisation,​
• results in persistent or significant disability/incapacity, or​

is a congenital anomaly/birth defect.

Question 10

Sponsors must complete a report about any SAEs to the FDA within how many days of discovering the event? ​

​

15 business days​

5 calendar days​

15 calendar days​

10 working days​

None of the above

Answer 10

15 calendar days​

Regulatory agencies should be notified (e.g., by telephone, facsimile transmission, or in writing) as soon as possible but no later than 7 calendar days after first knowledge by the sponsor that a case qualifies​

Followed by as complete a report as possible within 8 additional calendar days.

Question 11

Fatal or Life-Threatening Unexpected ADRs should be notified no later than 7 calendar days after first knowledge by the sponsor​

TRUE or FALSE?

Answer 11

1. TRUE​

Regulatory agencies should be notified (e.g., by telephone, facsimile transmission, or in writing) as soon as possible but no later than 7 calendar days after first knowledge by the sponsor that a case qualifies. Followed by as complete a report as possible within 8 additional calendar days.

Question 12

Non fatal or life-threatening should be reported as soon as possible but no later than 30 calendar days after first knowledge by the sponsor​

TRUE or FALSE?​

Answer 12

FALSE​

Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed as soon as possible but no later than 15 calendar days after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting

Question 13

_____ is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers.​

Options: ​

FDA Form 3455​

FDA Form 3500B​

FDA Form 3500A​

FDA Form 3500

Answer 13

C​

Form FDA 3500A is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers.

Question 14

_____ is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.​

Options: ​

FDA Form 3500A​

FDA Form 3500B​

FDA Form 3454​

FDA Form 3500

Answer 14

D​

Form FDA 3500 is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.