SOCRA - CCRP Exam with Questions and Answers 2024, Exams of Nursing

Download SOCRA - CCRP Exam with Questions and Answers 2024 and more Exams Nursing in PDF only on Docsity! Term: What is in 21 CFR Part 11? Definition: Electronic Records / Signatures Term: What is in 21 CFR Part 50? Definition: Informed Consent Term: What is in 21 CFR Part 56? Definition: IRBs Term: What is in 21 CFR Part 312? Definition: Investigational New Drug Applications Term: What is in 21 CFR Part 812? Definition: Investigational Device Exemptions Term: What is 45 CRF Part 46 Definition: Federal Research Term: What is the purpose of FDA Form 482? Definition: Notice of Inspection Term: What is the purpose of FDA Form 483? Definition: Inspectional Observations Term: What is the purpose of FDA Form 1572? Definition: Statement of Investigator Term: What is the purpose of FDA Form 3454? Definition: Financial Certification Term: What is covered in ICH E2A? Definition: Clinical Safety Data Management - Definitions and standards for Expedited Reporting. Term: Safety Pharmacology Studies Definition: Studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. Term: Goals of Animal Studies Definition: - Establish general safety in multiple species - Summarize toxicities observed - Determine the safety margins between the planned human dose range and toxic effects in animals - Optimize the dose range, formulation, and frequency of administration Term: Typical Non-Clinical Studies (2 types) Definition: Single-dose Toxicity studies (in multiple animal species) - results used to select doses for repeated dose studies. Repeated dose studies to assess the toxicity after multiple administrations - results used to determine doses used for chronic administration. Term: An IND permits... Definition: ...an unapproved drug to be shipped lawfully for the purpose of conduction investigations of the drug. Term: An IND goes into effect... Definition: ...30 days after the FDA receives it unless the FDA notifies the sponsor of clinical hold Term: Expanded Access Definition: Sometimes called "compassionate use," expanded access is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. Term: Define "clinical hold" Definition: A clinical hold is an order issued by the FDA to the Sponsor to delay a proposed clinical investigation or suspend an ongoing investigation. Proposed study - subjects man not be given the IND Ongoing study - no new subjects may be given the IND and subjects already taking the drug should be discontinued unless continuation is specially permitted by the FDA. Term: What are the grounds for a Clinical Hold in phase 1? Definition: - Unreasonable or significant risk - Investigators aren't qualified - IB is misleading, inaccurate, or incomplete - the IND doesn't contain sufficient information to assess risk Term: What are the additional grounds for Clinical Hold in phases 2 and 3? Definition: The protocol is clearly deficient in design to meet its stated objectives Term: Define a "device" Definition: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article, including any component, part or accessory which is: - Intended for use in the diagnosis of disease or conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals . - Intended to affect the structure or any function of the body of man or other animals. Which does NOT achieve its primary intended purposes through chemical action within or on the body and which is NOT dependent upon being metabolized for the achievement of its intended purposes. Term: What are the phases of device trials? Definition: - Animal Studies (PRN) - Pilot Study - 1st in man, exploratory - Pivotal Study - determine safety and efficacy - Post-Market Studies - design improvement, expansion of safety and effectiveness data, and development of new uses Term: What is a Class I device? Definition: Lowest Risk General controls are sufficient to provide reasonable assurance of safety and effectiveness. - prohibition against adulterated or misbranded devices - 510(k) requirements - Good Manufacturing Practices - Registration of manufacturing facilities - Listing of device types Examples: elastic bandages, exam gloves, hand-held surgical instruments Term: What is a Class II device? Definition: Moderate risk, usually requires a 510(k). General controls alone are insufficient to insure safety adn effectiveness. Special controls: - special labeling requirements - Mandatory performance standards - Post-Market surveillance Examples: powered wheelchairs, infusion pumps Term: What is a Class III device? Definition: Highest risk - PMA usually required. Devices for which insufficient information exists to assure safety and effectiveness solely through general and special controls. Usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, ir present a potential unreasonable risk of illness or injury. Term: 510(k) Clearance Definition: Sponsor submits data to demonstrate the device is "substantially equivalent" to an already marketed device. If FDA concurs, they notify the Sponsor that the device is "cleared" for marketing. Term: Pre-Market Approval (PMA) Definition: - Required process of scientific review to ensure the reasonable safety and effectiveness of medical devices. - FDA approval required before the device can be marketed. Term: The overall purpose of monitoring is to verify... Definition: - the rights and wellbeing of human subjects are protected - reported trial data are accurate, complete, and verifiable from source docs - the study is conducted in compliance with the protocol, GCP guidelines, and applicable regulations Term: Nuremberg Code Definition: - Voluntary consent is essential - Human experiments must be based on animal models and the natural history of the disease - Studies should be conducted by scientifically qualified persons with the highest degree of skill and care - Avoid suffering! - No expectation of death or disabling injury Term: Declaration of Helsinki Definition: - Created by the World Medical association - extension of the Nuremberg Code and a reference for docs involved in human research - the design and performance of experimental procedures formulated in a clear protocol and transmitted to a specially appointed independent committee for consideration, comment, and guidance Term: The Belmont Report has 3 principlals Definition: 1. Respect for Persons 2. Beneficence 3. Justice Term: The Belmont Report defines "practice" as... Definition: interventions designed solely to enhance wellbeing of the patient with reasonable expectation of success. Term: The Belmont Report defines "research" as... Definition: interventions actively designed to test a hypothesis, draw a conclusion to develop or contribute to generalized knowledge. Term: Respect for Persons Definition: - Persons should be treated as independent agents - Those with diminished autonomy are entitled to protection - Subjects enter into research voluntarily and with adequate information Term: Beneficience Definition: - Respecting decisions - Protecting from harm - Securing wellbeing - DO NO HARM; maximize benefits while minimizing harms Term: Justice Definition: Fairness of distribution - potential participants should be treated equally. Who bears the burdens of research? No systematic selection of a class of individuals Who receives the benefits of research? Benefits not restricted to those who can afford it. Research should not involve persons from groups not likely to benefit from application of the research. Term: Safeguards for kids - greater than minimal risk studies Definition: - intervention/procedure holds out the prospect of direct benefit to the child OR - Study involves a monitoring procedure that is likely to contribute to subject's wellbeing - Provisions for getting kid's assent and guardians' consent Term: Safeguards for kids - greater than min risk AND no direct benefit for subject Definition: - Risk represents a minor increase over minimal risk - Experiences associated with the clinical trial are reasonably commensurate with those inherent in the actual or planned medical, dental, social, or educational situations - Provisions for getting kid's assent and guardians' consent Term: Exceptions to Informed Consent Definition: - life-threatening situation necessitating use of the test article - Informed consent cannot be obtained b/c of an inability to communicate with or obtain legally effective consent from the subject - Insufficient time to obtain consent from the subject's legal representative - No available alternative therapy that has equal or greater likelihood of saving the subject's life Term: Documentation of test article used w/o informed consent must be submitted to the IRB within... Definition: 5 working days after the use of the test article Term: What are the 4 types of controls? Definition: - Placebo-concurrent control - Active-treatment concurrent control - Dose-comparison concurrent control - No-treatment concurrent control Term: Placebo-controlled studies Definition: - placebo is expected to provide no or minimal efficacy - show the IP is better than inactive treatment - valuable reference for safety endpoints - generally used when the treatment period is short and lack of treatment is not expected to have clinically relevant impact on the subject's overall health Term: Active-Treatment concurrent control studies Definition: - active controls are generally used when it's unethical to use a placebo (e.g., chemo) - generally intended to demonstrate equivalence or non-inferiority - comparative treatment has a similar mechanism of action and is considered SOC for the disease or condition Term: Dose-comparison studies Definition: - Multiple dose levels of the investigational product might be evaluated in the same study, with prospective randomization - may be designed as a dose-escalation study - primary objectives are to compare efficacy and safety at multiple doses Term: No-treatment control Definition: - long-term safety studies for chronic conditions that require continued treatment - objective is to assess maintenance of clinical response over time and assess safety with extended exposure Term: Adverse Event (AE) Definition: Any untoward medical occurrence in a subject to whom a medicinal product has ben administered, including occurrences that aren't necessarily caused or related to that product.