CCRC terms
Adverse Drug Reaction - answer All noxious and unintended responses to a medicinal
product related to any dose should be considered an ADR.
Blinding - answer A procedure in which one or more parties to the trial are kept unaware
of the treatment assignments.
Single Blind - answer Refers to the subject being unaware of the treatment assignment
Double Blind - answer Refers to the subject, investigator, monitor, and sometimes
analyst being unaware of the treatment.
Case Report Form (CRF) - answer A printed, optical, or electronic document designed
to record all of the protocol required information to be reported to the sponsor on each
trial subject.
Comparator - answer An investigational or marketed product, or a placebo, used as
reference in a clinical trial.
Contract Research Organization - answerA person or organization contracted by the
sponsor to preform one or more of a sponsor's trial-related duties and functions.
Good Clinical Practice (GCP) - answerA 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 the trial subjects are protected.
Institutional Review Board - answerAn 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 the trial.
Investigational Product - answerA pharmaceutical form of an active ingredient or
placebo being tested or used as reference in a clinical trial
Investigator's Brochure - answerA compilation of the clinical and non-clinical data on the
investigational product(s) which is relevant to the study of the investigational product(s)
in human subjects.
Protocol - answerA document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
, Serious Adverse Event (SAE) - answerAny untoward medical occurrence that at any
dose:
-results in death,
-is life-threatening,
-requires inpatient hospitalization or prolongation
-results in persistent or significant disability/incapacity
Source data - answerAll information in original records and certified copies of original
records of clinical findings, observations, or other activities in a trial necessary for the
reconstruction and evaluation of the trial.
Sponsor - answerAn individual, company, institution, or organization which takes
responsibility for the initiation, management, and/or financing of a clinical trial.
Standard Operating Procedures (SOPs) - answerDetailed, written instructions to
achieve uniformity of the performance of a specific function.
The purpose of an IRB is to: - answerProtect the rights and welfare of human subjects
of research.
The investigator must obtain IRB approval of the study and the consent form: -
answerBefore enrolling any patients in the study
The IRB must inform the investigator the study has been approved by: - answerWritten
notification saying it has been approved
For initial approval of proposed research, the investigaot must submit to the IRB: -
answerThe full protocol and the informed consent
Any proposed advertising for the study: - answerMust be submitted to the IRB and
approved before it can be used
Any amendment that _____________ must be approved by the IRB prior to
implementation - answerIncreases the risks to subjects
Which of the following is necessary to waive consent: - answerSubject is unable to give
consent, no time or unable to contact next of kin, life-threatening condition, no other
treatment available.
T/F: The investigator's signature must be on the consent form? - answerFalse
The process by which a subject voluntarily confirms his or her willingness to participate
in a clinical trial is known as: - answerInformed Consent
Adverse Drug Reaction - answer All noxious and unintended responses to a medicinal
product related to any dose should be considered an ADR.
Blinding - answer A procedure in which one or more parties to the trial are kept unaware
of the treatment assignments.
Single Blind - answer Refers to the subject being unaware of the treatment assignment
Double Blind - answer Refers to the subject, investigator, monitor, and sometimes
analyst being unaware of the treatment.
Case Report Form (CRF) - answer A printed, optical, or electronic document designed
to record all of the protocol required information to be reported to the sponsor on each
trial subject.
Comparator - answer An investigational or marketed product, or a placebo, used as
reference in a clinical trial.
Contract Research Organization - answerA person or organization contracted by the
sponsor to preform one or more of a sponsor's trial-related duties and functions.
Good Clinical Practice (GCP) - answerA 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 the trial subjects are protected.
Institutional Review Board - answerAn 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 the trial.
Investigational Product - answerA pharmaceutical form of an active ingredient or
placebo being tested or used as reference in a clinical trial
Investigator's Brochure - answerA compilation of the clinical and non-clinical data on the
investigational product(s) which is relevant to the study of the investigational product(s)
in human subjects.
Protocol - answerA document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
, Serious Adverse Event (SAE) - answerAny untoward medical occurrence that at any
dose:
-results in death,
-is life-threatening,
-requires inpatient hospitalization or prolongation
-results in persistent or significant disability/incapacity
Source data - answerAll information in original records and certified copies of original
records of clinical findings, observations, or other activities in a trial necessary for the
reconstruction and evaluation of the trial.
Sponsor - answerAn individual, company, institution, or organization which takes
responsibility for the initiation, management, and/or financing of a clinical trial.
Standard Operating Procedures (SOPs) - answerDetailed, written instructions to
achieve uniformity of the performance of a specific function.
The purpose of an IRB is to: - answerProtect the rights and welfare of human subjects
of research.
The investigator must obtain IRB approval of the study and the consent form: -
answerBefore enrolling any patients in the study
The IRB must inform the investigator the study has been approved by: - answerWritten
notification saying it has been approved
For initial approval of proposed research, the investigaot must submit to the IRB: -
answerThe full protocol and the informed consent
Any proposed advertising for the study: - answerMust be submitted to the IRB and
approved before it can be used
Any amendment that _____________ must be approved by the IRB prior to
implementation - answerIncreases the risks to subjects
Which of the following is necessary to waive consent: - answerSubject is unable to give
consent, no time or unable to contact next of kin, life-threatening condition, no other
treatment available.
T/F: The investigator's signature must be on the consent form? - answerFalse
The process by which a subject voluntarily confirms his or her willingness to participate
in a clinical trial is known as: - answerInformed Consent
