ICH Gap Analysis

Question 1

Answer 1

c. to standardize the design, conduct, recording, and reporting of clinical trials.

Question 2

What does “LAR” stand for?

Answer 2

Legally ACCEPTABLE Representative

Question 3

Answer 3

A, B and D

Question 4

Which of the following documents are required by the IRB before approval? (Select all that apply)

a. Clinical Trial Budget

b. Subject information Leaflet

c. Telephone script for patient recruitment

d. Study Protocol

Answer 4

Subject information leaflet
Telephone script for recruitment
& Study protocol

Question 5

During the trial, who is responsible for communicating with the IRB?

Answer 5

The investigator

Question 6

According to the Declaration of Helsinki, an investigator may use an unproven intervention method. True or False?

Answer 6

True

Question 7

A monitor is tasked to select investigators for a new upcoming oncology trial. What evidence of qualifications should the potential investigator be able to provide to be considered for the conduct of the trial? (Select all applicable)

a. University degree

b. an up to date CV

c. evidence of GCP training

d. a log of all the training the investigator has ever completed

Answer 7

b. an up to date CV
c. evidence of GCP training

Question 8

How can expected Adverse Events (AEs) be described? (Select all that apply)

a. Those that are seen in every day clinical practice

b. Those that are consistent with the applicable product information

c. Those that have been reported in previous clinical or preclinical trials

d. Those that are not very severe

Answer 8

a. Those that are seen in every day clinical practice
b. Those that are consistent with the applicable product information

Question 9

Answer 9

All except, encouraging subjects to report all Adverse Events, this is not a responsibility of the investigator

Question 10

Design in which subjects are randomized to one of two or more arms, each arm being allocated a different treatment. These treatments will include the IP at one or more doses, and one mor more control treatments, such as placebo and/or an active compound.

a. crossover

b. adaptive

c. parallel

d. randomized

Answer 10

c. parallel

Question 11

Who may have direct access to the subjects’ medical records?

Select all that apply

a. All those named in the informed consent form signed by the subject.
b. All qualified hospital staff.
c. The investigator by default
d. The monitor by default.

Answer 11

a. All those named in the informed consent form signed by the subject.
c. The investigator by default