Standard of Care - ANSWER ✔ Accepted treatment practices for patient care.
Protocol Requirements - ANSWER ✔ Specific guidelines participants must follow
in trials.
Quality Management Systems - ANSWER ✔ Framework ensuring quality in
clinical trial processes.
,Randomization - ANSWER ✔ Process of assigning participants to treatment
groups.
Electronic Data Capture - ANSWER ✔ System for collecting and managing trial
data electronically.
Source Data Verification (SDV) - ANSWER ✔ Process of confirming data against
original records.
Pharmacovigilance - ANSWER ✔ Monitoring drug safety and adverse effects.
Essential Documents - ANSWER ✔ Key records required for conducting clinical
trials.
Record Retention - ANSWER ✔ Policies for maintaining trial documentation.
Study Documentation Practices (ALCOA-C) - ANSWER ✔ Standards for
maintaining accurate trial records.
Principal Investigator (PI) Responsibilities - ANSWER ✔ Oversight of study
conduct and data integrity.
Regulatory Compliance - ANSWER ✔ QA/QC requirements, data collection and
reporting requirements, source data access and verification
Importance of Subject Stipend: - ANSWER ✔ Must be approved by IRB to make
sure the timing and amount is not coercive nor influences the subject
Belmont Report (1979) - ANSWER ✔ ethical principles and guidelines for the
protection of human subjects of research.
respect for persons - ANSWER ✔ individuals should be treated as autonomous
agents and persons with diminished autonomy are entitled to protection
An autonomous person - ANSWER ✔ A person capable of deliberation about
personal goals and of acting under the direction of such deliberation
, Beneficence - ANSWER ✔ Do not harm and maximize possible benefits and
minimize possible harms
Crossover - ANSWER ✔ when each subject is randomized to a sequence of two or
more treatments and hence acts as their own control for treatment comparisons
Parallel - ANSWER ✔ when subjects are randomized to 1 of 2 or more arms, each
arm being allocated a different treatment. Each treatment will include their
investigational product at one or more doses, and one or more control treatments,
such as placebo and/or an active comparator
A sponsor is developing an IP for treatment of a medical condition where there is
one additional marketed product approved for treatment of the condition. The
sponsor believes their product works as well or better than the current treatment
with fewer side effects. What is the most-likely study design they will use to test
the efficacy of the IP? - ANSWER ✔ Non-Inferiority
What type of clinical trial most likely requires enrollment of the largest number of
research subjects? - ANSWER ✔ Therapeutic confirmatory (aka Pivotal Trial, Ph
III, or Comparative Efficacy)
Minimum number of membors on an IRB/IEC - ANSWER ✔ 5 .. lay people and
medical professionals can be part of the IRB/IEC
Who is responsible for providing the protocol - ANSWER ✔ The Sponsor
The purpose of the SIV is to - ANSWER ✔ -review standard procedures
-review the protocol
-review the blank eCRFs
Minimum SAE reporting requirements - ANSWER ✔ - Subject details (ID not
name)
- IP
- Interventions for the event that is being reported
- Details of the event
- Details on the reporter of the event
- Admin and sponsor or company details/
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