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CRC Foundations Questions & right answers.
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CRC Foundations Questions & right answers.
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CRC Foundations Questions & rightanswers.
In drug development, when is an Investigational New Drug (IND) application submitted to the FDA? ANS
- If the product candidate is a drug or a biologic. After submitting the application to the FDA, the
sponsor must wait the review period of 30 calendar days before starting clinical trials. FDA will notify the
applicant if it has questions or concerns.
In Medical Device development, define premarket review. ANS - The FDA's process to evaluate the
safety and effectiveness of devices that support or sustain human life, are of substantial importance in
preventing impairment of human health, or which present a potential, unreasonable risk of illness or
injury.
Premarket review for Non-Significant Risk Devices and Significant Risk Devices. ANS - Non-Significant
Risk Devices are usually exempt from premarket review required for high-risk devices and do not require
clinical trial data before being commercialized. Studies with nonsignificant risk devices must be
approved by only the IRB before the study can begin.
For Significant Risk Devices, an Investigational Device Exemption (IDE) must be submitted to and
approved by the FDA before the trial can begin. An IDE allows the investigational device to be used in a
clinical study in order to collect safety and effectiveness data required to support a Premarket Approval
(PMA) application.
Drug development study designs categories ANS - Randomized (blind or double blind), Medical Device
(pilot followed by pivotal trial), and Other (observational, retrospective, and historical).
What is the Drug Development process? ANS - Discovery, Phase 1, Phase 2, Phase 3, New Drug
Application (NDA) or, in the case of a biologic, a Biologics License Application (BLA), and Phase 4.
The first phase of clinical development focuses on establishing safety and tolerability of an
investigational drug.
,The second phase of clinical development focuses on obtaining evidence of therapeutic efficacy
indicating that the molecule has the desired effect.
The knowledge gathered from phase 1 and 2 trials is used to design one or more phase 3 clinical trials
intended to determine if the new drug is safe and effective. A phase 3 trial is usually randomized,
double-blinded, and controlled.
In Phase 4, after the FDA approves a drug and it is commercially available, it may be necessary to gather
more information about the product through the controlled mechanism of a clinical trial
Define Study Sponsor ANS - A study sponsor initiates the clinical investigation, oversees the entire
process, develops regulatory strategy, and manages interactions with the regulatory authorities.
The sponsor may be an individual, a pharmaceutical company, a governmental agency (such as the
National Institutes of Health), a cooperative research group, an academic institution, or a nonprofit
organization. The sponsor is usually also the funding source for the trial.
Industry-Sponsored Studies vs Sponsor-Investigator Studies (Investigator-Initiated Studies) ANS - An
Industry-Sponsored study is conducted by a biomedical company that initiates and oversees the clinical
trial and is the holder of the Investigational New Drug (IND) or Investigational Device Exemption (IDE).
In Sponsor-Investigator studies, an investigator both initiates and conducts a clinical trial without the
direct involvement of an industry sponsor.
Define Study Endpoints and examples. ANS - Study endpoints are outcome measures used to assess the
results of a clinical trial.
Examples include Adverse Events (AEs) and measurements of disease progression or survival that can be
correlated with the safety and effectiveness of the study intervention.
In additional to clinical events, diaries, and questionaries.
Study endpoints are chosen based on the primary objective of a trial.
,Clinical Study protocol ANS - 1. Objectives that address specific questions or a hypothesis that the trial
will investigate.
2. Scientific background and study rationale providing the basis for the trial.
3. Trial design that is consistent with the goals of the study; single or multicenter, open-label, or
randomized and double-blind; depicted diagrammatically in a study schema.
4. Selection and enrollment of subjects defining which subjects will be included in the study by
specifying inclusion and exclusion criteria.
5. Procedure and research events section with the study-treatment plan, visits, clinical procedures,
laboratory tests, and other measures.
6. Management of Adverse Events (AEs) with a list of expected Adverse Events (AEs) and actions to be
taken, including study drug dose adjustments and other actions to be taken.
7. Statistical considerations providing rationale for the choice of study design, sample size (number of
subjects), and how data will be handled and analyzed.
8. Data collection and recordkeeping section describing how the data will be captured and managed for
integrity and confidentiality; how Adverse Events should be recorded and reported; identifies
information that will be retained for each subject and the responsible party that will oversee the data
retention.
9. Quality control and quality assurance parameters including methods to ensure that the study is
conducted according to the protocol and regulatory requirements; and that the data are reflective of the
source documents.
10. Assurance that the safety of the human subjects is protected, including communication methods of
safety reporting, subject confidentiality, and IRB oversight; that the information to be shared with
investigators and study team members will be unbiased.
Financial factors to consider when evaluating the feasibility of a site. ANS - If the study is sponsored by
a pharmaceutical company, an accurate budget needs to be developed and should include costs
associated with:
Research team effort or time
Investigator oversight
Study-related procedures
Exams
Training
Pharmacy
Site overhead
, Subject stipends
Data collection
Handling of AEs and SAE reporting
Monitoring visits
Regulatory and IRB preparations
Other activities associated with the study
Clinical Study Team ANS - The Principal Investigator (PI), Sub-Investigator (SI), Clinical Research
Coordinator (CRC), The Study Monitor (CRA), and Institutional Review Board (IRB).
The PI's role includes:
Leading the team
Making medical decisions
Providing oversight for the study by answering questions from study subjects
Ensuring the safety and welfare of human subjects
Being involved or delegating the informed consent process, and ensuring that the study team and
subjects enrolled in the study are adhering to the study protocol.
The SI assists the PI by performing delegated tasks that are outlined in the protocol. The SI plays a
significant role in the study and can perform clinical tasks and make medical decisions if appropriately
licensed for those activities.
The CRC usually manages subject enrollment and maintains protocol compliance. The CRC may
participate in:
Prescreening subjects for eligibility
Recruiting subjects
Obtaining informed consent
Explaining the study to subjects and answering their questions
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