Practice Questions Flashcards
Which patient population best aligns with crossover study design?
- patients with chronic conditions
- may be infeasible or unethical for curative treatments or rapidly changing conditions
Effect size
Quantitative measure of the magnitude of a phenomenon (correlation between variables)
Why is the influence of confounders reduced in crossover studies?
Each patient is their own control
Variable that influences both dependent and independent variables
Confounders
Inch to centimeter
x 2.54
Acute bacterial infection is suggested by
High neutrophil levels
Acute hepatitis is suggested by-
High SGOT and ALT
Liver function tests
AST, ALT, ALK Phos and HCT
*F to *C
-32 x 5/9
*C to *F
x 1.8+32
What is the purpose of ICH-GCP?
Standardize the design, conduct, recording and reporting of clinical trials
What is the purpose of the IRB/IEC?
Protect subject safety
Who is responsible for providing the trial protocol?
Sponsor
According to ICH, “LAR” stands for Legally Authorized Representative
False- Legally Acceptable Representative
What does DSMB stand for?
Data Safety and Monitoring Board
World Medical Association’s (WMA) ethical principles for medical research involving human subjects is called-
Declaration of Helsinki
The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial-
Informed consent of trial subjects
One primary purpose of a Phase 1 study-
Determine the metabolic and pharmacologic action of the drug in humans
Purpose of the Data Safety Monitoring Board
Assess the progress of a clinical trial, the safety data and critical efficacy endpoints
Purpose of the initiation visit
- Review the protocol
- Review standard procedures
- Review blank Case Report Forms (CRFs)
Who is ultimately responsible for source data verification (SDV)?
Monitor
Every research study involving human subjects must be registered in a publicaly accessible database before recruitment of the first subject
True
Declaration of Helsinki was developed by-
World Medical Association
Which groups can be members of an IRB/IEC?
- Lay people
- Medical professionals
What format should approval be received from the IRB/IEC?
Written
How to best define Adverse Drug Reaction (ADR)?
A noxious and unintended response to the investigational drug
Which would be most appropriate for adverse event (AE) reporting?
Documenting and reporting all AEs no matter how trivial they appear
Which criteria is described by ICH-GCP as necessary for classifying an AE as an adverse drug reaction?
Causal relationship is at least a reasonable possibility
What information needs to be included in the subject’s medical records?
- Occurrence of any AEs
- Medical history
- Randomization number
Who conducts clinical research Quality Control activities?
Monitor
According to the Declaration of Helsinki, physicians may use an unproven intervention?
True
Minimum amount of time after formal discontinuation of clinical development of an investigational product that essential documents should be retained?
2 years after last marketing application approval in an ICH-GCP region
Medical research with a vulnerable group is only justified if the research is responsive to health needs or priorities of this group and cannot be carried out in a non-vulnerable group. This groups should stand to benefit from the knowledge, practices or interventions that result from the research.
True
