Podcast Beta
Questions and Answers
What does ACRP stand for?
What does SOCRA stand for?
What does CRO stand for?
What does ICH stand for?
Signup and view all the answers
What does GCP stand for?
Signup and view all the answers
What does IND stand for?
Signup and view all the answers
What does NDA stand for?
Signup and view all the answers
What does EDC stand for?
Signup and view all the answers
What occurs during Phase 1 clinical trials?
Signup and view all the answers
Describe the aim of Phase 2 clinical trials.
Signup and view all the answers
What is the purpose of Phase 3 clinical trials?
Signup and view all the answers
What does IRB stand for?
Signup and view all the answers
What does PK stand for in clinical research?
Signup and view all the answers
What is an SAE?
Signup and view all the answers
What does AE stand for?
Signup and view all the answers
What does LTF stand for?
Signup and view all the answers
What does efficacy mean in the context of clinical research?
Signup and view all the answers
What is FDA Form 1572?
Signup and view all the answers
What does QSEM stand for?
Signup and view all the answers
What does IB stand for?
Signup and view all the answers
Match the following terms with their definitions:
Signup and view all the answers
What does IP stand for?
Signup and view all the answers
What does 21 CFR Part 11 regulate?
Signup and view all the answers
What does 21 CFR Part 50 cover?
Signup and view all the answers
What does 21 CFR Part 50 Subpart B address?
Signup and view all the answers
What does 21 CFR Part 50 Subpart B 50.27 specify?
Signup and view all the answers
What does ICF stand for?
Signup and view all the answers
What does 21 CFR Part 54 relate to?
Signup and view all the answers
What does FDA form 3454 represent?
Signup and view all the answers
What does FDA Form 3455 refer to?
Signup and view all the answers
What does 21 CFR Part 56 cover?
Signup and view all the answers
What does OHRP stand for?
Signup and view all the answers
What does NIH stand for?
Signup and view all the answers
What does DOA represent?
Signup and view all the answers
What does CRA stand for?
Signup and view all the answers
What does CRC stand for?
Signup and view all the answers
What does SIV stand for?
Signup and view all the answers
What does IM stand for?
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.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
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.
