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CCRP CERT YOLO Exam with Questions and Complete Solutions (A+ Guaranteed)
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CCRP CERT YOLO Exam withQuestions and Complete Solutions (A+
Guaranteed)
Essential Documents correct answers Documents that individually and collectively
permit evaluation of the conduct of a study and the quality of the data produced.
Evaluable Subject correct answers A subject who meets the criteria for evaluation described
in the protocol or the statistical plan.
Food and Drug Administration (FDA) correct answers An agency of the U.S. government
which oversees the study of investigational drugs and grants marketing approval for new drugs.
Sometimes referred to as the agency.
Form FDA 1751 correct answers Investigational New Drug Application (IND) coversheet
Form FDA 1572 correct answers Statement of Investigator
Freedom of Information (FOI) correct answers A U.S. law which permits corporations and
individuals to request copies of internal documents generated by U.S. government
agencies, including FDA.
Good Clinical Practice (GCP) correct answers A 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.
Good documentation practice (GDP) correct answers Best practice concepts of
good documentation
,Good x Practice (GxP) correct answers Generic term in which x=clinical, laboratory
or manufacturing
Health Insurance Portability and Accountability Act (HIPAA) correct answers USA law that protects
health insurance for workers when they change/lose their jobs and addresses the security
& privacy of health data, and requires national standards for electronic healthcare
transactions and national identifiers for providers, health plans, and employers.
Investigator's Brochure (IB) correct answers A collection of preclinical and clinical data
about the investigational drug and/or device. Also referred to as Clinical Investigation
Brother or Investigational Drug Brochure.
Informed Consent (IC) correct answers A process by which a subject voluntarily confirms his
or her willing ness to participate in a trial
Informed Consent Document/Informed Consent Form (ICD or ICF) correct answers The legal
written record that the subject, or his/her representative, agrees to voluntarily participate in
the investigation.
International Conference on Harmonization (ICH) correct answers A Committee consisting of
US, EU and Japanese members organized to develop guidelines for the conduct of clinical
trials (this applies to pharmaceutical products).
Investigational Device Exemption (IDE) correct answers An official proposal through which a
sponsor obtains FDA approval of its plan to test a new medical device in human clinical trials
Investigational New Drug Application (IND) correct answers An official proposal through which
a sponsor obtains FDA approval of its plan to test a new drug in human clinical trials.
,Investigational product (IP) correct answers A pharmaceutical form of an active ingredient
or placebo being
Investigational Site correct answers The location where the study is being conducted
(also referred to as the clinical site or the site).
Investigator Agreement correct answers A written contractual document between the sponsor
and investigator which includes a commitment by the investigator to comply with all regulatory
obligations.
Monitoring correct answers 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), GCPs and the applicable regulatory requirements.
Investigator (PI/Subl) correct answers A person responsible for the conduct of the clinical trial
at an investigational site. If a trial is conducted by a team of individuals, the investigator is the
responsible leader of the team.
New Drug Application (NDA) correct answers An application to the FDA for a license to
market a new drug in the United States.
Pharmaco-dynamics (PD) correct answers The branch of pharmacology that studies reactions
between drugs and living structures, including the processes of bodily responses to
pharmacological, biochemical, physiological, and therapeutic effects.
Pharmaco-economics correct answers Branch of economics that applies cost-benefit, cost-
effectiveness, cost-minimization, cost-utility analyses to compare the economics of different
pharmaceutical products or to compare drug therapy to other treatments.
Placebo correct answers An inactive substance sometimes included as a control in a clinical trial.
, Pharmacokinetics (PK) correct answers The study of bodily absorption, distribution, metabolism
and excretion of compounds and medicines.
Pre-Market Approval (PMA) correct answers AN application to the FDA for a license to market
a new medical device in the United States.
Patient Reported Outcomes (PRO) correct answers Questionnaire used to collect patient
responses; usually completed personally by patient
Protocol correct answers A formal written document which states the rational, objectives, and
statistical design of the trial.
Protocol Deviation correct answers Failure by the investigational team or subject to follow any
aspect of the protocol.
Quality Assurance (QA) correct answers Systems and processes established to ensure that the
trial is performed and the data is generated in compliance with GCP, SOPs, and the protocol.
Quality of Life (QOL) correct answers Description of the physical, psychological, and
social dimensions of the health status of a subject.
Randomization correct answers The process of assigning trial subjects to treatment of control
groups using an element of chance to determine the assignments in order to reduce bias.
Regulatory authority correct answers A body which has the power to regulate; includes
the authority(ies) that review submitted clinical data and those that conduct inspections.
Remote Date Entry (RDE) correct answers A computerized system designed for the collection
of data in electronic format. See also "Electronic Data Capture."
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