My

Question 1

What is the minimum criteria for reporting unexpected SAE’s? (4)

Answer 1

1. identifiable patient
2. suspected medicinal product
3. identifiable reporting source
4. event outcome that be be identified as serious & unexpected

Question 2

True or False? All cases judged by either the PI or the Sponsor as having a reasonable suspected causal relationship to the IP qualify as adverse drug reactions.

Answer 2

True

Question 3

What source documents are used to determine if an AE is serious or not serious? (2)

Answer 3

1. Investigator Brochure
2. Reports that add significant info on specificity or severity of a known serious ADR

Question 4

In the list of SAE’s how is “other important medical events” defined as?

Answer 4

May jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the SAE list.

Question 5

Which serves as a guideline for regulatory reporting?

a. seriousness

b. severity

Answer 5

a. seriousness

Question 6

Monitoring should verify that the conduct of the trial is in compliance with the currently approved _________, with GCP, and with applicable ___________ requirements.

Answer 6

Protocol, regulatory

Question 7

Monitoring should verify that the reported trial data are _______, _________, and ________ from the source documents.

Answer 7

ACV. Accurate, complete, verifiable.

Question 8

AE seriousness is based on what 2 things?

Answer 8

1. patient outcome
2. event outcome

Question 9

The severity of an AE is described as?

Answer 9

INTENSITY

mild- does not hinder daily activity
moderate- hinders but does not prevent daily activity
severe- prevents performance of daily activity

Question 10

What makes an AE unexpected? Select all that apply.

1. it was not observed before
2. PI did not expect it to occur
3. it occurred more often than before
4. it occurred sooner than before

Answer 10

1 & 3

1. it was not observed before
2. it occurred more often than before

Question 11

Adverse Drug Reaction can occur with IUO or marketed product. T/F?

Answer 11

True

Question 12

Intention to Treat Analysis

Answer 12

Based on the group the participants were originally assigned to, regardless of what treatment they received. This means that all participants who are randomized are included in the statistical analysis, regardless of whether they dropped out, fully adhered to the treatment, or switched to an alternative treatment. ITT analysis is often used in superiority trials to avoid bias.

Question 13

Per-Protocol Analysis

Answer 13

A method of comparing treatment groups in clinical trials that only includes patients who followed the protocol exactly (this is how analysis generally goes).

Question 14

AE’s can happen _________ IP administration.

a. before

b. during

c. after

Answer 14

c. after

Question 15

2 reasons why ICH E2A was developed:

Answer 15

1. Provide standard definitions & terminology for key aspects of clinical safety reporting
2. Create an appropriate mechanism for handling expedited safety reporting during investigational phase.

Question 16

Should expedited reporting occur in the following situation?

AE occurs in 3 subjects. It is listed in the IB.

Answer 16

No expedited reporting required.

Question 17

Name 3 purposes of Monitoring:

Answer 17

1. Ensure rights & well-being of subjects are protected
2. Ensure data are accurate, complete, and verifiable.
3. Ensure compliance with GCP and protocol

Question 18

Which two items are optional in the IB?

1. Safety & efficacy
2. Marketing experience
3. Non-clinical studies
4. Signature page
5. Summary of data & guidance for the PI
6. Confidentiality statement

Answer 18

4. Signature page
5. Confidentiality statement