Practice Questions

Question 1

Determines therapeutic benefit and usually done in a larger, specific population-

Answer 1

Phase 3

Question 2

Therapeutic use begins, after drug approval-

Answer 2

Phase 4

Question 3

Most typical studies investigate human pharmacology. Initial administration or investigational new drug into humans. Most common in healthy subjects.

Answer 3

Phase 1

Question 4

Providing a unified standard for Europe, US and Japan to facilitate the acceptance of clinical trials

Answer 4

Mission statement of ICH

Question 5

Investigator can be defined as-

Answer 5

• Responsible leader of clinical research team at the site, may be called principle investigator
• Person responsible for the conduct of the clinical trial at trial site

Question 6

Sub-investigator defined as-

Answer 6

Any individual member of clinical research team designated and supervised by the investigator to perform trial-related procedures or to make trial related decisions

Question 7

Sponsor defined as-

Answer 7

Individual or company, institution or organization which takes responsibility for initiation, management and/or financing of the trial

Question 8

Essential documents defined as-

Answer 8

Documents which individually or collectively permit evaluation of the conduct of a study and the quality of data produced

Question 9

Source data defined as-

Answer 9

All information in original records and certified copies of original records of critical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial

Question 10

When should the contractual agreement between the sponsor and investigator be signed?

Answer 10

Before the trial

Question 11

Which documents is the investigator obliged to comply with during the trial?

Answer 11

• ICH-GCP
• Trial protocol
• All applicable laws and regulations

Question 12

What does the IRB/IEC evaluate?

Answer 12

• Scientific tenability of the trial
• Subject-selection procedure
• Rights, safety and well-being of the subjects participating in the trial

Question 13

A potential investigator usually only receives a protocol and investigator brochure to review from a sponsor when?

Answer 13

After signing a confidentiality agreement

Question 14

NOT a required element of an informed consent-

Answer 14

A listing of all site personnel who will be involved in the research

Question 15

Which should the investigator do if an SAE occurs?

Answer 15

• Inform the sponsor immediately
• Inform IRB/IEC, if required

Question 16

After an SAE occurs, how should a subject identification occur on the immediate and follow-up reports?

Answer 16

Subject identification number

Question 17

In the event of a subject’s death, what additional information should be supplied to the sponsor?

Answer 17

• Terminal medical reports
• Autopsy report

Question 18

What documentation should be supplied to the sponsor before the study?

Answer 18

• CVs of all investigators and other study personnel who are significantly involved in trial related duties
• Signed contract between sponsor and investigator

Question 19

Who must sign an ICF?

Answer 19

• Subject with subject’s legal representative
• Person who conducted ICF interview

Question 20

Which are required by the IRB/IEC before approval?

Answer 20

• Telephone script for patient recruitment
• Subject information leaflet
• Study protocol

Question 21

What details need to be documented in the subject notes when an AE occurs?

Answer 21

• When the event occurred
• Severity of the event

Question 22

Who is responsible for appropriate monitoring of clinical trials?

Answer 22

The sponsor

Question 23

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

Answer 23

The investigator

Question 24

A candidate presents for a monitor position. What qualifications should the potential monitor be able to provide proof of to be considered?

Answer 24

• Be familiar with GCP
• Have clinical knowledge to monitor a trial
• Have scientific knowledge to monitor a trial

Question 25

An experienced research coordinator is training a junior coordinator on safety reporting. What should they train on?

Answer 25

• All subjects identified by a unique code, rather than their name
• Report unexpected serious AEs/drug reactions per applicable regulatory requirements
• Supply the sponsor and IRB/IEC with any additional requested information for reported deaths