Principles of Clinical Research Questions with Correct
Answers
Scientific Method Correct Answer-Observation
Question
Hypothesis
Prediction
Experiment
Analysis
Decision
What is Clinical Research? Correct Answer-NIH Definition:
Patient-oriented research
Epidemiologic and behavioral research
Outcomes research and health
Patient-Oriented Research Correct Answer-"Research conducted with
human subjects (or on material of human origin such as tissues,
specimens and cognitive phenomena) for which an investigator directly
interacts with human subjects"
Who is involved? Correct Answer-Investigator
Study Coordinator
Patients
Clinical Research Associates (CRAs)
,Contract Research Organizations (CROs)
Drug Companies
Food and Drug Administration (FDA)
Institutional Review Board (IRB)
What is a Clinical Trial? Correct Answer-"Prospective biomedical or
behavioral research study of human subjects that is designed to answer
specific questions about biomedical or behavioral interventions (drugs,
nutritional supplements, surgical intervention, or devices)"
Control Correct Answer-Intervention used to compare to the
experimental intervention in a clinical study
Placebo
Active
Uncontrolled
Human Subject Correct Answer-A clinical research study participant
Patient
Healthy Volunteer
Can receive control or experimental intervention
Protocol Correct Answer-Detailed written plan of study
Objectives
Design
,Methodology
Statistical Analysis
Organizes the study
• Writing protocol forces investigator:
- Organize, clarify, refine all elements of a study - Enhances study
efficiency
Case Report Form (CRF) Correct Answer-Document designed to collect
all relevant study data
Can be electronic (eCRF)
Also known as data collection form (DCF)
Data management
Informed Consent Correct Answer-"Process by which a participant or
legal guardian voluntarily confirms his or her willingness to participate
in a study"
Documented by means of a written, signed, and dated informed consent
form which must be IRB-approved
, • Begins with recruitment
• Initial consent
• Risks, benefits, alternatives, procedures & purpose explained
• Opportunity for potential participant to ask questions
• New info shared as it becomes available
• Consent revisited periodically in lengthy studies
Institutional Review Board (IRB) Correct Answer-"Independent body
constituted of medical, scientific, and nonscientific members"
"Responsible for ensuring the protection of the rights, safety, and well-
being of human subjects involved in a study"
"Reviewing, approving, and providing continuing review of studies,
protocols and amendments, and of the methods and material used for
obtaining and documenting informed consent of study participants"
Good Clinical Practices (GCPs) Correct Answer-"Standard for the
design, conduct, performance, monitoring, auditing, recording, analyses,
and reporting of clinical trials"
"Provides assurance that the data and reported results are credible and
accurate"
"Provides assurance that the rights, integrity, and confidentiality of trial
participants are protected"
Answers
Scientific Method Correct Answer-Observation
Question
Hypothesis
Prediction
Experiment
Analysis
Decision
What is Clinical Research? Correct Answer-NIH Definition:
Patient-oriented research
Epidemiologic and behavioral research
Outcomes research and health
Patient-Oriented Research Correct Answer-"Research conducted with
human subjects (or on material of human origin such as tissues,
specimens and cognitive phenomena) for which an investigator directly
interacts with human subjects"
Who is involved? Correct Answer-Investigator
Study Coordinator
Patients
Clinical Research Associates (CRAs)
,Contract Research Organizations (CROs)
Drug Companies
Food and Drug Administration (FDA)
Institutional Review Board (IRB)
What is a Clinical Trial? Correct Answer-"Prospective biomedical or
behavioral research study of human subjects that is designed to answer
specific questions about biomedical or behavioral interventions (drugs,
nutritional supplements, surgical intervention, or devices)"
Control Correct Answer-Intervention used to compare to the
experimental intervention in a clinical study
Placebo
Active
Uncontrolled
Human Subject Correct Answer-A clinical research study participant
Patient
Healthy Volunteer
Can receive control or experimental intervention
Protocol Correct Answer-Detailed written plan of study
Objectives
Design
,Methodology
Statistical Analysis
Organizes the study
• Writing protocol forces investigator:
- Organize, clarify, refine all elements of a study - Enhances study
efficiency
Case Report Form (CRF) Correct Answer-Document designed to collect
all relevant study data
Can be electronic (eCRF)
Also known as data collection form (DCF)
Data management
Informed Consent Correct Answer-"Process by which a participant or
legal guardian voluntarily confirms his or her willingness to participate
in a study"
Documented by means of a written, signed, and dated informed consent
form which must be IRB-approved
, • Begins with recruitment
• Initial consent
• Risks, benefits, alternatives, procedures & purpose explained
• Opportunity for potential participant to ask questions
• New info shared as it becomes available
• Consent revisited periodically in lengthy studies
Institutional Review Board (IRB) Correct Answer-"Independent body
constituted of medical, scientific, and nonscientific members"
"Responsible for ensuring the protection of the rights, safety, and well-
being of human subjects involved in a study"
"Reviewing, approving, and providing continuing review of studies,
protocols and amendments, and of the methods and material used for
obtaining and documenting informed consent of study participants"
Good Clinical Practices (GCPs) Correct Answer-"Standard for the
design, conduct, performance, monitoring, auditing, recording, analyses,
and reporting of clinical trials"
"Provides assurance that the data and reported results are credible and
accurate"
"Provides assurance that the rights, integrity, and confidentiality of trial
participants are protected"
