ICH-E6A - General Defintions

Question 1

What is GCP?

Answer 1

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Question 2

What is the objective of ICH-E6?

Answer 2

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. New addendum E2 adds switzerland

Question 3

What is an audit trail?

Answer 3

Documentation that allows reconstruction of the course of events.

Question 4

Pick an option that is not a CRF a. printed b. electronic c. optical d. vocal

Answer 4

D.

Question 5

Describe what a clinical trial/study is ?

Answer 5

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.

Question 6

What is a comparator (product)?

Answer 6

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.

Question 7

What is not a form of documentation: a. written b. electronic c. magnetic d. optical e. scans f. x-rays g. electrocardiogram h. first person account

Answer 7

H. First person account

Question 8

Define GCP

Answer 8

standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected

Question 9

T/F: a IDMC and DSMB is An independent data-monitoring committee that may be established by the physician to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the physician whether to continue, modify, or stop a trial.

Answer 9

False-established by the Sponsor, and recommendations to sponsor on trial stoppage.

Question 10

Is an impartial witness the same as the LAR?

Answer 10

No– Impartial Witness A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

Question 11

What is an IP?

Answer 11

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Question 12

T/F: The compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects is known as the protocol?

Answer 12

False, Definition is the IB

Question 13

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 is called the_______?

Answer 13

LAR-Legally authorized/acceptable representative

Question 14

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s) is known as.___________

Answer 14

QA-Quality Assurance

Question 15

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 is known as____________.

Answer 15

QC-Quality Control

Question 16

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias is known as_____

Answer 16

Randomization

Question 17

Define SAE/Serious ADR

Answer 17

Any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity, or - is a congenital anomaly/birth defect (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

Question 18

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

Answer 18

Source Data

Question 19

Detailed, written instructions to achieve uniformity of the performance of a specific function is_________?

Answer 19

SOPs

Question 20

T/F If a subject has an AE, you can’t just submit the subjects identification code, you must submit real patient information?

Answer 20

False

Question 21

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting) is: a. SUSAR b. UADR c. AE d. ADR

Answer 21

B. UADR

Question 22

The following are examples of Vulnerable Subjects: Select all the apply: a. subordinate hospital and laboratory personnel b. medical, pharmacy, dental, and nursing students c. members of a group with a hierarchical structure d. employees of the pharmaceutical industry e. members of the armed forces f. persons kept in detention g. patients with incurable diseases, h. persons in nursing homes, i. unemployed or impoverished persons, j. patients in emergency situations, k. ethnic minority groups, l.homeless persons, nomads, refugees, m. minors, and those incapable of giving consent. n. All of the above

Answer 22

LOL N.

Question 23

Define Certified Copy

Answer 23

A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.

Question 24

What is this describing? process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results

Answer 24

Validation of Computerized Systems.

Question 25

Examples of vulnerable subjects

Answer 25

Vulnerable Subjects-. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing
students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.