Pre-Assessment for ALL STUDENTS – LMS

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Question 1 of 25

1. Question

1. What is the most important consideration during a clinical trial?

Safety and well-being of the trial subject

Adherence to protocol

Proof of efficacy

Correct

Incorrect

Question 2 of 25

2. Question

2. Who is responsible for trial conduct at the site ?

The Sponsor

The Clinical Research Associate (CRA)

The Principal Investigator (PI)

The Clinical Research Coordinator

Correct

Incorrect

Question 3 of 25

3. Question

3. What does ICH GCP defines as: “A document describing the objective(s), design, methodology, statistical considerations, & organization of a trial.”

The Trial Master File

The Clinical Trial Agreement

The Monitoring Report

The Protocol

Correct

Incorrect

Question 4 of 25

4. Question

4. Prior to starting a clinical trial, the protocol must be approved by the:

Regional Regulatory Authority (e.g. the FDA)

The ethical review board (REB/IRB/IEC)

Sponsor

Trial Steering Committee

Correct

Incorrect

Question 5 of 25

5. Question

5. What must be obtained from all potential trial subjects before they take part in the trial ?

Non-Disclosure Agreement

Legal waiver, absolving the sponsor from legal consequences

Physical exam

Signed Informed Consent

Correct

Incorrect

Question 6 of 25

6. Question

6. What is the minimal frequency for continuing review conduct by the Institutional Review Board / Independent Ethics Committee (IRB/IEC) regardless of the degree of risk to human subjects ?

Once per month

Every 6 months

Once per year

No minimum is stated in ICH GCP

Correct

Incorrect

Question 7 of 25

7. Question

7. What is the minimum number of members on an IRB/IEC ?

No minimum number is stated

4 members

5 members

6 members

Correct

Incorrect

Question 8 of 25

8. Question

8. There must be at least one IRB/IEC member with the following characteristic:

Representative of the Sponsor

Layperson (non-scientific)

A patient with the target disease/health concern of interest

Someone with a formal training in ethics

Correct

Incorrect

Question 9 of 25

9. Question

9. How long must the IRB/IEC maintain their records securely?

For 2 years following the start of the trial

For 2 years following the start of the trial

For 3 years following the start of the trial

For 3 years following the completion of the trial

Correct

Incorrect

Question 10 of 25

10. Question

10. What is the general purpose of the Investigator’s Brochure ?

It is a comprehensive description of all clinical & non-clinical data known about the investigational product

It describes the procedures and goals of the proposed clinical trial

It is a critical analysis by the Principal Investigator concerning the proposed trial

It is the legal agreement between the Principal Investigator and the sponsor

Correct

Incorrect

Question 11 of 25

11. Question

11. What word is missing about Informed Consent: “Neither the investigator, nor the trial staff, should ______________ or unduly influence a subject to participate or to continue to participate in a trial.”

Manipulate

Coerce

Convince

Compensate

Correct

Incorrect

Question 12 of 25

12. Question

12. What does GCP say about CRF corrections: “Any change or correction to a CRF should be dated, initialled, and explained (if necessary) and should not _________________”

Provide a data trail

Obscure the original entry

Leave visible the original entry

Contradict the original entry

Correct

Incorrect

Question 13 of 25

13. Question

13. What WORD IS MISSING? “All serious adverse events (SAEs) should be reported immediately to the sponsor except for _______________”

Those that the investigator deems unimportant

Those identified in the protocol as not requiring reporting

Those that are previously known to occur

Those that spontaneously resolve within 24 hours

Correct

Incorrect

Question 14 of 25

14. Question

14. The investigator must conduct the trial in compliance with 3 requirements. Which is not one of them ?

GCP Guidelines

Applicable regulatory requirements

Approved protocol

FDA Certification

Correct

Incorrect

Question 15 of 25

15. Question

15. Which of the following is not one of the 3 main goals of clinical trial monitoring?

Ensuring protection of the rights and well-being of the trial subject

Ensuring that data from the trial is in line with the sponsor’s goals

Ensuring that data is accurate, complete and verifiable

Ensuring that trial conduct is in compliance with GCP, the protocol and regulations

Correct

Incorrect

Question 16 of 25

16. Question

16. What does GCP say about the required extent of monitoring activities ?

They should be adequate

They should occur at least every month

They should occur at least every 2 months

No specific mention is made of this in GCPOption 4

Correct

Incorrect

Question 17 of 25

17. Question

17. What essential document does the following refer to ? “________ is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures.”

The Clinical Trial Protocol

The Trial Master File (TMF)

The Clinical Trial Agreement (CTA)

The Investigator’s Brochure (IB)

Correct

Incorrect

Question 18 of 25

18. Question

18. What is described in the following GCP definition: “A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).”

An Internal Audit

For-Cause Inspection

Routine Inspection

Site Regulatory Analysis

Correct

Incorrect

Question 19 of 25

19. Question

19. What is described by the following GCP definition: “An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial”.

Trial Subject Representative

Legal Representative

Legally Acceptable Representative

Legally Commissioned Representative

Correct

Incorrect

Question 20 of 25

20. Question

20. What does ICH GCP describe as: “The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.”

Quality Control

Quality Assurance

Audits

Correct

Incorrect

Question 21 of 25

21. Question

21. What documents the existence of the subject and substantiates integrity of trial data collected?

Case Report Forms

Monitoring Reports

Informed Consent Forms

Source Documents

Correct

Incorrect

Question 22 of 25

22. Question

22. What document, created in 1964, provides the foundation for ethical considerations in clinical research?

Nuremberg Code

Helsinki Declaration

Belmont Report

WHO Guidelines

Correct

Incorrect

Question 23 of 25

23. Question

23. Which of the following statements best describes an Adverse Event?

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.

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which has a definite causal relationship with this treatment.

Any untoward physical change in a patient or clinical investigation subject administered a pharmaceutical product which is strongly suspected of having a causal relationship with this treatment.Option 3

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which is suspected of interacting with another drug.

Correct

Incorrect

Question 24 of 25

24. Question

24. What term describes “Documentation that allows reconstruction of the course of events.”

Source Documents

Case Report Forms

Monitoring Reports

Audit Trail

Correct

Incorrect

Question 25 of 25

25. Question

25. What is a term for “An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.”

Contrast Product

Comparator

Baseline Product

Reference Product

Correct

Incorrect

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Pre- Assessment - ALL STUDENTS