General GCP 16

Question 1 of 22

1. Question

According to ICH GCP what do the following have in common? Patients with incurable diseases and homeless persons?

Nothing
Neither should be included in a clinical trial
A witness should sign the consent form
Both are considered vulnerable subjects

Question 2 of 22

2. Question

Which one of the following trial designs is specifically referred to in ICH GCP?

Cross Over
Interventional
Observational
Parallel

Question 3 of 22

3. Question

According to ICH GCP when, under normal circumstances, should the monitor visit the site?

They don’t have to visit
Before, during and after the study
Every 4-6 weeks
At least once

Question 4 of 22

4. Question

What words complete the statement in ICH GCP: The sponsor should determine for investigational products acceptable storage temperatures, storage conditions, storage times, XXXXX, and devices for product infusion, if any.

resupply procedure
relabelling and randomisation methods
reconstitution fluids and procedures
return storage conditions

Question 5 of 22

5. Question

The addendum to ICH E6 GCP is expected to be complete by what date?

Nov-15
Mar-16
Nov-16
Mar-17

Question 6 of 22

6. Question

Which of the following is the ICH GCP Glossary Definition of a Trial Site?

The primary location where trial related activities are conducted.
The location(s) where trial-related activities are actually conducted.
The location of the legal entity contracted to the sponsor for trial related activities.
The location from which the investigator is ultimately employed or contracted.

Question 7 of 22

7. Question

According to ICH GCP who should maintain a system for retrieving investigational products?

The investigator
The pharmacist
The sponsor
The regulatory authority

Question 8 of 22

8. Question

According to the principles of ICH GCP the confidentiality of what should be protected,

Commercially sensitive information
Records which could identify subjects
Data recorded in the CRF
All of the above

Question 9 of 22

9. Question

According to ICH GCP which section of the protocol should contain “A description of the measures taken to minimize/avoid bias”?

Trial Objectives and Purpose
Trial Design
Assessment of Efficacy
Statistics

Question 10 of 22

10. Question

According to ICH GCP chapter 8 what is the purpose of filing the Certificate of Analysis of investigational products shipped?

To document identity, purity and strength of investigational products to be used in the trial
To document shipment of investigational product to the site
To document authorisation to use the investigational product for the trial
There is no requirement to file the Certificate of Analysis

Question 11 of 22

11. Question

According to ICH GCP the sponsor should obtain the investigator’s agreement to…..?

To conduct the trial in accordance with GCP and applicable regulatory requirements
To comply with procedures for data recording/reporting
To permit monitoring
All of the above

Question 12 of 22

12. Question

According to ICH GCP “the observations and findings of the auditor should be XXXXX”?

Objective
Documented
Kept confidential
Disseminated to the study team

Question 13 of 22

13. Question

Which of the following is most true regarding the list of essential documents in ICH GCP chapter 8?

The sponsor can select from this list the documents they want to include
The TMF must reflect this list accurately
It should be supplemented or may be reduced where justified
It has been changed significantly by the addendum

Question 14 of 22

14. Question

According to ICH GCP where would the Shipping Records for Investigational Products and Trial Related Materials be filed?

Investigator Site File
Sponsor File
Both
Neither

Question 15 of 22

15. Question

According to ICH GCP what do the following have in common? The master randomisation list and the final closeout visit monitoring report.

Both are generated by the monitor
Neither is a requirement according to ICH GCP chapter 8
Both are filed in the sponsor file and not the investigator file.
Nothing

Question 16 of 22

16. Question

In which chapter of ICH GCP are essential documents listed?

5.0
6.0
7.0
8.0

Question 17 of 22

17. Question

ICH GCP Section 6 states that which of the following would be generally included in the Background Information of a trial protocol

The potential market size for the product in development
Summary of the known and potential risks and benefits, if any, to human subjects
A detailed discussion of the ethical considerations of the trial design
A discussion of alternative designs that would adequately answer the same trial objectives

Question 18 of 22

18. Question

According to ICH GCP who can obtain consent

Only the investigator
Only the investigator or another physician
Only the investigator or another healthcare professional
Only the investigator or a person designated by the investigator

Question 19 of 22

19. Question

Which country/region introduced risk based GCP inspections in May 2009?

USA
EU
Australia
UK

Question 20 of 22

20. Question

Is a site selection visit required by ICH GCP?

Yes
Yes unless you have worked with the site before
No, but the site should be visited before the study starts
No, it’s only routine monitoring visits that are required

Question 21 of 22

21. Question

What word is missing from this ICHGCP definition of an Adverse Event: Any medical occurance in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

direct
investigational
untoward
No word is missing

Question 22 of 22

22. Question

According to ICH GCP what is the timeline for an investigator to report a SAE to the sponsor?

Immediately
24 hours
7 days
at the next monitoring visit

Assessment Summary

Information

Results