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Clinical Research Terminology Flashcards
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Clinical Research Terminology Flashcards

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Questions and Answers

What does ACRP stand for?

  • American Clinical Research Partnership
  • Association of Clinical Research Professionals (correct)
  • Association of Clinical Researchers and Practitioners
  • Advanced Clinical Research Practices

    • What does SOCRA stand for?

  • Society of Clinical Research Associates (correct)
  • Society for Optimizing Clinical Research Applications
  • Symposium on Clinical Research Advances
  • Standard Organization for Clinical Research Approvals

    • What does CRO stand for?

  • Contract Research Organization (correct)
  • Clinical Research Office
  • Clinical Research Organization
  • Certified Research Organization

    • What does ICH stand for?

    <p>International Council of Harmonization</p> Signup and view all the answers

    What does GCP stand for?

    <p>Good Clinical Practice</p> Signup and view all the answers

    What does IND stand for?

    <p>Investigational New Drug</p> Signup and view all the answers

    What does NDA stand for?

    <p>New Drug Application</p> Signup and view all the answers

    What does EDC stand for?

    <p>Electronic Data Capture</p> Signup and view all the answers

    What occurs during Phase 1 clinical trials?

    <p>First time tested in humans, small number of subjects enrolled, looks closely at pharmacokinetics and is concerned mostly with safety.</p> Signup and view all the answers

    Describe the aim of Phase 2 clinical trials.

    <p>A few hundred subjects are enrolled to start looking at efficacy of the drug and see if the dose from phase 1 is effective.</p> Signup and view all the answers

    What is the purpose of Phase 3 clinical trials?

    <p>To enroll hundreds to thousands of subjects and look at long-term effects of the drug.</p> Signup and view all the answers

    What does IRB stand for?

    <p>Institutional Review Board</p> Signup and view all the answers

    What does PK stand for in clinical research?

    <p>Pharmacokinetics</p> Signup and view all the answers

    What is an SAE?

    <p>Serious Adverse Event</p> Signup and view all the answers

    What does AE stand for?

    <p>Adverse Event</p> Signup and view all the answers

    What does LTF stand for?

    <p>Loss to follow up</p> Signup and view all the answers

    What does efficacy mean in the context of clinical research?

    <p>Does it work? Is it beneficial?</p> Signup and view all the answers

    What is FDA Form 1572?

    <p>Statement of Investigator</p> Signup and view all the answers

    What does QSEM stand for?

    <p>Quality guidelines, Safety Guidelines, Efficacy guidelines &amp; Multidisciplinary guidelines</p> Signup and view all the answers

    What does IB stand for?

    <p>Investigator's Brochure</p> Signup and view all the answers

    Match the following terms with their definitions:

    <p>GCP = Good Clinical Practice IRB = Institutional Review Board NDA = New Drug Application CRA = Clinical Research Associate</p> Signup and view all the answers

    What does IP stand for?

    <p>Investigational Product</p> Signup and view all the answers

    What does 21 CFR Part 11 regulate?

    <p>Electronic Records; Electronic Signatures</p> Signup and view all the answers

    What does 21 CFR Part 50 cover?

    <p>Protection of Human Subjects</p> Signup and view all the answers

    What does 21 CFR Part 50 Subpart B address?

    <p>Informed consent of human subjects</p> Signup and view all the answers

    What does 21 CFR Part 50 Subpart B 50.27 specify?

    <p>ICF must be IRB approved, signed and dated by the subject/LAR, a signed copy must be given to subject/LAR, and subjects must have ample time to review the document.</p> Signup and view all the answers

    What does ICF stand for?

    <p>Informed Consent Form</p> Signup and view all the answers

    What does 21 CFR Part 54 relate to?

    <p>Financial Disclosure by Clinical Investigators</p> Signup and view all the answers

    What does FDA form 3454 represent?

    <p>Certification - Financial Interests and Arrangements of Clinical Investigators</p> Signup and view all the answers

    What does FDA Form 3455 refer to?

    <p>Disclosure - Financial Interests and Arrangements of Clinical Investigators</p> Signup and view all the answers

    What does 21 CFR Part 56 cover?

    <p>IRB/IEC - functions, approval, and membership of IRB/IEC</p> Signup and view all the answers

    What does OHRP stand for?

    <p>Office for Human Research Protections</p> Signup and view all the answers

    What does NIH stand for?

    <p>National Institutes of Health</p> Signup and view all the answers

    What does DOA represent?

    <p>Delegation of Authority</p> Signup and view all the answers

    What does CRA stand for?

    <p>Clinical Research Associate</p> Signup and view all the answers

    What does CRC stand for?

    <p>Clinical Research Coordinator</p> Signup and view all the answers

    What does SIV stand for?

    <p>Site Initiation Visit</p> Signup and view all the answers

    What does IM stand for?

    <p>Investigators Meeting</p> Signup and view all the answers

    Study Notes

    Clinical Research Terminology

    • ACRP: Association of Clinical Research Professionals focused on supporting clinical research professionals.
    • SOCRA: Society of Clinical Research Associates, an organization that provides professional development and certification for clinical research professionals.
    • CRO: Contract Research Organization, a service organization that provides support to the pharmaceutical, biotechnology, and medical device industries to conduct research.
    • ICH: International Council of Harmonization, which aims to ensure that drug development and registration processes are harmonized internationally.
    • GCP: Good Clinical Practice, guidelines that outline the responsibilities of clinical trial stakeholders (manufacturers, sponsors, investigators, IRBs) to ensure safety and integrity in clinical research.

    Drug Application Processes

    • IND: Investigational New Drug, an application submitted to the FDA to begin clinical trials with a new drug.
    • NDA: New Drug Application, submitted to the FDA to market a new drug after it has been tested in clinical trials.

    Data and Safety Considerations

    • EDC: Electronic Data Capture, systems used to collect clinical trial data in digital form.
    • Phase 1 Clinical Trials: Initial studies in humans, focusing on safety and pharmacokinetics with a small number of subjects.
    • Phase 2 Clinical Trials: Evaluate drug efficacy with hundreds of subjects, determining effective dosages from Phase 1 results.
    • Phase 3 Clinical Trials: Large-scale studies with thousands of subjects, assessing long-term effects and overall efficacy of the drug.
    • IRB: Institutional Review Board, responsible for ensuring ethical treatment of research subjects.

    Research Metrics and Events

    • PK: Pharmacokinetics, the study of how a drug is absorbed, distributed, metabolized, and excreted in the body.
    • CRF: Case Report Form, a tool used to collect data from each participating subject in a clinical trial.
    • SAE: Serious Adverse Event, any untoward medical occurrence that is serious and occurs during clinical trials.
    • AE: Adverse event, any undesirable experience associated with the use of a medical product.

    Participant Management

    • LTF: Loss to follow-up, a situation where subjects drop out of a study before its completion.
    • Efficacy: Measurement of a drug's effectiveness in producing a beneficial result.
    • Informed Consent Form (ICF): Document that provides potential participants with important information about a clinical trial.

    Regulatory Compliance

    • FDA Form 1572: Statement of Investigator, detailing the responsibilities and qualifications of those conducting a trial.
    • QSEM: Quality guideline, Safety Guidelines, Efficacy guidelines, and Multidisciplinary guidelines for clinical trials.
    • 21 CFR Part 11: Regulations for electronic records and electronic signatures.
    • 21 CFR Part 50: Regulations protecting human subjects in research.
    • 21 CFR Part 54: Financial Disclosure requirements for clinical investigators.

    Investigator and Staff Roles

    • PI: Principal Investigator, the individual responsible for conducting a clinical trial.
    • IP: Investigational Product, a drug or device being tested in clinical research.
    • CRA: Clinical Research Associate, responsible for monitoring clinical trials.
    • CRC: Clinical Research Coordinator, oversees day-to-day clinical trial operations.
    • SIV: Site Initiation Visit, the first visit to a clinical site to ensure everything is ready for the trial.
    • IM: Investigators Meeting, a meeting of the investigators involved in the trial to discuss protocols and expectations.

    Ethical Considerations

    • OHRP: Office for Human Research Protections, overseeing the ethical conduct of research involving human subjects.
    • NIH: National Institutes of Health, an agency responsible for conducting and supporting medical research.

    Financial Transparency

    • FDA Form 3454: Certification of financial interests and arrangements of clinical investigators.
    • FDA Form 3455: Disclosure of financial interests and arrangements of clinical investigators.

    Guidelines for Ethical Research

    • GCP 13 Principles: Sets forth ethical guidelines to ensure safety, well-being, and rights of clinical trial subjects, emphasizing the need for proper oversight, informed consent, and confidentiality.

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    Test your knowledge of key terms in clinical research with these flashcards. Covering essential acronyms like ACRP, SOCRA, and GCP, this quiz is perfect for aspiring clinical research professionals. Enhance your understanding of industry standards and organizations.

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