ICH Clinical Safety Data Management

Question 1

Adverse Event/Experience

Answer 1

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment

Question 2

Adverse Drug Reaction (pre-approval)

Answer 2

all noxious and unintended responses to a medicinal product related to any dose should be considered an ADR

Question 3

Adverse Drug Reaction (marketed medicinal product)

Answer 3

a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function

Question 4

Unexpected Adverse Drug Reaction

Answer 4

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

Question 5

Serious adverse event

Answer 5

Any untoward medical occurrence that at any dose:
1) Results in Death
2) Is Life-Threatening
3) Requires inpatient hospitalization or prolongation of existing hospitalization
4) results in persistent or significant disability/incapacity
5) is a congenital anomaly/birth defect

Question 6

Severity

Answer 6

used to describe the intensity of a specific event (as in mild, moderate, or severe mycoardial infarction); the event iteself, however, may be or relatively minor medical significance (such as a severe headache).

Question 7

Serious

Answer 7

Based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient’s life or functioning.

Question 8

Reporting time frame for ADRs (not fatal or life-threatening)

Answer 8

15 days after first knowledge by sponsor that case meets minimum criteria for expedited reporting

Question 9

Reporting time frame for ADRs (fatal or life-threatening) [ADR and report]

Answer 9

7 days after first knowledge by sponsor that case qualified, followed by complete as possible report within 8 additional calendar days

Question 10

It is the responsibility of the _____ to decide whether active comparator drug reactions should be reported to the other manufacturer and/or regulatory agencies

Answer 10

sponsor

Question 11

What is quality assurance?

Answer 11

Planned and systematic activities to ensure that quality is maintained during the trial and that data are generated, documented and reported according to GCP and regulatory requirements. (Actions to ensure errors don’t happen)

Question 12

What is quality control?

Answer 12

operational activities taken to verify that the requirements for quality have been fulfilled (Checking if errors did happen).

Question 13

Serious Adverse Events (SAEs) or Serious Adverse Drug Reactions (Serious ADRs) are untoward medical occurrences that at any dose _______.

Answer 13

Result in death
Are life threatening
Require inpatient hospitalization or prolonged hospitalization
Result in persistent or significant disability/incapacity
Is a congenital anomaly or birth defect.

Question 14

What is an Unexpected Adverse Drug Reaction?

Answer 14

Any adverse reaction in which the nature or severity is not consistent with the product information for the trial (Investigators brochure, etc.)

Question 15

According to ICH GCP, whom are generally considered vulnerable populations?

Answer 15

Individuals whose willingness to volunteer may be or have a higher chance of being unduly influenced by their expected benefits of participating or perceived retaliation of not participating.