ACRP CCRC EXAM PREP, CCRC EXAM PREP, ACRP CCRC,

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ACRP CCRC EXAM PREP, CCRC EXAM PREP, ACRP CCRC,

*CCRC STUDY SET

Actual Qs and Ans - Expert-Verified Explanation -Guaranteed passing score -100 Questions and Answers

-Format: Multiple-choice / Flashcard

Question 1: Abbreviation: "AE"

Answer:

Adverse Event

Question 2: 1.1 elements of a protocol

ICH 6

Answer:

Methods and timing for assessing, recording, and analysing of efficacy parameters.

Question 3: Audit

Answer:

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).

Question 4: 1.1 elements of a protocol

ICH 6

Answer:

Name, title, address, and telephone number(s) of the sponsor's medical expert (or dentist when appropriate) for the trial.

Question 5: Independent Data-Monitoring Committee (IDMC)

Answer:

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Question 6: 1.1 elements of a protocol

ICH 6

Answer:

Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any.

Question 7: Investigator's Brochure

Answer:

A 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

Question 8: Adverse Event (AE)

Answer:

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.

Question 9: Monitoring

Answer:

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Question 10: 1.1 elements of a protocol

ICH 6

Answer:

Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s).

Question 11: Audit Report

Answer:

A written evaluation by the sponsor's auditor of the results of the audit.

Question 12: Inspection

Answer:

The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

Question 13: Quality Control (QC)

Answer:

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.

Question 14: Sponsor

Answer:

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

Question 15: 1.1 elements of a protocol

ICH 6

Answer:

Subject exclusion criteria.

Question 16: Regulatory Authorities

Answer:

Bodies having the power to regulate.

Question 17: 1.1 elements of a protocol

ICH 6

Answer:

Specification of the efficacy parameters.

Question 18: 1.1 elements of a protocol

ICH 6

Answer:

Subject inclusion criteria.

Question 19: Documentation

Answer:

All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Question 20: Single-blinding

Answer:

usually refers to the subject(s) being unaware

Question 21: 1.1 elements of a protocol

ICH 6

Answer:

The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial.

Question 22: Institutional Review Board (IRB)

Answer:

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Question 23: Compliance (in relation to trials)

Answer:

Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.