CCRP SOCRA Exam Questions and Answers 2023/2024, Exams of Nursing

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CCRP SOCRA Exam Graded A+ April 30 1996 - ANSWER ICH GCP Development Date Quality - ANSWER ICH Q Efficacy - ANSWER ICH E Safety - ANSWER ICH S Multidisciplinary - ANSWER ICH M guidance for industry, consolidated guideance - ANSWER ICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWER ICH E2A Safety pharmacology studies for human pharmaceuticals - ANSWER ICH S7A Electronic records, electronic signatures - ANSWER 21 CFR Part 11 Informed Consent - ANSWER 21 CFR Part 50 Financial Disclosures - ANSWER 21 CFR Part 54 Institutional Review Board - ANSWER 21 CFR Part 56 IND Application - ANSWER 21 CFR 312 New Drug Application - ANSWER 21 CFR 314 Investigational Device Exemption - ANSWER 21 CFR 812 21 CFR Part 814 - ANSWER pre market approval of medical devices 45 CFR Part 46 - ANSWER Federal Research Studies that investigate the potential undesirable PD effects of a substance on physiological functions in relation to exposure in the therapeutic range or above - ANSWER Safety Pharmacology Studies (Pre-Clinical) 1) To Identify undesirable PD properties of a substance that may have relevance to its human safety. 2) To evaluate adverse PD and/or pathophysio effects of a substance observed in toxicology studies 3)to investigate the mechanism of the adverse PD effects observed and/or suspected - ANSWER Drug Development Safety Pharmacology Study Objectives (3) 1) Cardiovascular 2)Respiratory 3)CNS - ANSWER Three vital organ considered highest priority 1) PK and toxicokinetic 2) Single dose toxicity 3) Repeated dose toxicity 4) Local tolerance 5) Genotoxicity 6) Carcinogenicity 7) Reproduction toxicity 8) Supplemental studies if needed - ANSWER Types of Non-Clinical Studies (Animal Trials) Study that investigates the mode of action and/or effects of a drug substance in relation to its desired therapeutic target - ANSWER Primary Pharmacodynamic Studies Studies that investigate the mode of action and/or effects of a drug substance not related to its desire therapeutic target - ANSWER Secondary Pharmacodynamic Studies Blood Pressure Heart Rate ECG/EKG Repolarization/conductance abnormalities - ANSWER Core Battery for Cardiovascular System Respiratory Rate Functional Assessments (tidal volume, hgb Oxygen saturation) - ANSWER Core Battery for Respiratory System Motor activity behavioral changes coordination sensory/motor reflex response temperature - ANSWER Core Battery for Central Nervous System Investigational New Drug Application FDA - ANSWER Before clinical trials can be initiated, an application containing the appropriate information must be submitted to regulatory authorities, in the USA this is called XXXX and submitted to the XXX (21 CFR Part 312) Unapproved drug to be shipped lawfully for the purpose of conducting investigations of the drug - ANSWER An IND permits what? (21 CFR Part 312) 1) Initial Safety, dose escalation studies to determine MTD 2) PK and PD property, might be cross over design 3) Absorption, distribution, metabolism and excretion studies 4) Efficacy assessment, if possible - ANSWER Types of Phase I Trials 1) Initial demonstration of efficacy in subjects with the condition under investigation 2) obtain short term safety - ANSWER Goals of Phase II Trials 1) Confirmation of short term efficacy and safety 2) Establish long term efficacy and safety 3) Assess overall therapeutic value - ANSWER Goals of Phase III trials Phase III - ANSWER What phase of study usually has the largest number of subjects per study? Phase I - ANSWER What phase of study is usually single-center? Phase II/III - ANSWER What phases of stuides are usually multicenter? 1) Address FDA requirements for additional information not in NDA 2) Continue to assess overall therapeutic value 3)Surveillance for less common adverse events - ANSWER Goals of Phase IV Trials 1976 - ANSWER What year was the Medical Device Amendment? Medical Device Reporting - ANSWER 21 CFR Part 803 Investigational Device Exemption - ANSWER 21 CFR Part 812 Premarket Approval of Medical Devices - ANSWER 21 CFR Part 814 Quality System Regulations - ANSWER 21 CFR Part 820 Medical Device Classification Procedures - ANSWER 21 CFR Part 860 1) Achieve their primary intended purpose through chemical action within the body 2) Are dependent upon being metabolized for the primary achievement of the primary intended purpose - ANSWER Device definitions excludes what 2 type of products 1976, With Medical Device Amendments - ANSWER When was 510K Clearance Established? Clearance - ANSWER What is a 510k? 1) Required process of scientific review to ensure the reasonable safety and effectiveness of medical devices 2) FDA approval required before the device can be legally marketed - ANSWER Pre- Market Approval Requirements Lowest Risk, 510K often not required - ANSWER How do you define Class I Devices? Class I, II, III - ANSWER How are devices distinguished by risk? Moderate risk, usually requires 510k, might require PMA - ANSWER How do you define a device with Class II risk? Highest risk, PMA required - ANSWER How do you define a device with Class III risk? Elastic bandages, exam gloves, hand-held surgical instruments - ANSWER Examples of Class I devices 1) Prohibition against adulterated or misbranded devices 2) Premarket notification 510k requirements 3) GMPs 4) Registration of manufacturing facilities 5) listing of device types - ANSWER What are the general controls that provide reasonable assurance of safety for a device? Class I - ANSWER What type of device is sufficiently assured by general device controls? 1) Special labeling requirements 2) mandatory performance standards 3) post-market surveilance - ANSWER In addition to general controls, Class II devices are also subject to these types of special controls 1) Are usually those that support or sustain human life 2) are of substantial importance in preventing the impairment of human health 3)Present a potential, unreasonable risk of illness or injury - ANSWER Class III Devices Descriptions Replacement heart valve silicone-gel filled breast implants implanted cerebella stimulators implantable pacemakeres - ANSWER Examples of Class III Drugs Powered wheel chairs infusion pumps surgical drapes - ANSWER Examples of Class II devices Determined by the nature of the harm that may result to the subject in the study - ANSWER How is risk determined in device studies? 1) In an Implant 2)is used in supporting or sustaining life 3)is of substantial importance in diagnosing, curing, mitigating or treating disease or other prevents impairment of human health 4)otherwise presents a potential for serious risk to the health, safety, or welfare of a subject - ANSWER A Significant Risk (SR) Device Study is defined as: Does not meet the criteria for significant risk - ANSWER How do you define a non- significant risk device study? The sponsor, the IRB evaluates the determination - ANSWER Who makes the initial determination of SR or NSR? The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams and tests - ANSWER IRB definition of Minimal Risk Significant Risk Trials - ANSWER What type of device studies are subject to all IDE regulations (21 CFR Part 812) Non-significant risk trials - ANSWER What type of device studies are subject to abbreviated IDE regulations? (21 CFR Part 812.2b) Pilot Study Pivotal Study - ANSWER Types of Device Trials the shipment of a device for the purpose of conducting investigations of the device without complying without FDA requirements that would apply to devices in commercial distribution - ANSWER What does an Investigational Device Exemption (IDE) permit? 1)Legally marketable device in accordance with its labeling 2)diagnostic device complying with labeling requirements, testing is non-invasive 3)Does not require invasive sampling procedure 4)Does not introduce energy into subject 5) It is not used as a diagnostic procedure without confirmation by a medically established diagnostic product - ANSWER Devices can be granted IDE if: 1) Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a device 2)if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application 4) Significant payments of other sorts to investigator or institution supporting activities of investigator - ANSWER What are 4 types of financial disclosures? All amounts - ANSWER What is the $ reportable amount for a financial disclosure if the amount is based on study outcome? All amounts - ANSWER What is the $ reported amount for a financial disclosure for proprietary interest in the test product? All amounts - ANSWER What is the $ reported amount for a financial disclosure for equity interest in the sponsor? >$50,000 - ANSWER What is the $ reported amount for a financial disclosure for equity interest in a publicly traded company? >$25,000 - ANSWER What is the $ reported amount for a financial disclosure for significant payments? Contract Research Organization - ANSWER Who may the sponsor transfer responsibility of duties or functions? Monitor Responsibilties - ANSWER ICH E6, Section 5.18 1) Verify the rights and well-being of human subjects are protected 2)Reported trial data are accurate, complete, and verifiable from source documents 3)The study is conducted in compliance with the study protocol, the GCP guidelines and applicable regulations - ANSWER What are the primary purposes for study monitoring? 1) The investigator's name and site location 2) date of the visit 3) monitor's name 4) site personell contacted 5)summary of what information was reviewed 6)significant findings and corrective action - ANSWER Written monitoring reports should include what elements? Investigator Responsibilities - ANSWER 21 CFR 312.60-70 Investigator Responsibilities - ANSWER ICH E6 Section 4 1572 - ANSWER What form documents investigator agreement to investigator responsibilities in drug trials? Maintain adequate and accurate records Investigator responsibilitiy - ANSWER 21 CFR Part 312.62 Make study records available for inspection - ANSWER 21 CFR Part 312.68 1) Inventory of product received by site, and date 2) Dispensing and return information for each subject 3)Specific protocol information like batch numbers, expiration dates, serial numbers, unique codes assigned to trial subjects - ANSWER Drug accountability records should contain: Single line through the error Enter correct information Initial and date the change Provide explanation if needed Do not obliterate error No erasures No white-Out - ANSWER How should source document corrections be made according to GCP guidelines? 1947 - ANSWER When was the Nuremberg code developed? 1) Voluntary consent 2) Fruitful results 3) Based on animal studies 4)avoid unnecessary physical or mental suffering 5)should not be conducted if death or disability will occur with a priori knowledge 6)humanitarian Benefits outweigh risk 7) proper facilities and preparation 8)conducted by qualified individuals 9)freedom to withdraw consent - ANSWER What did the Nuremberg code establish? 1964 - ANSWER When was the Declaration of Helsinki? Reiterated Nuremberg Code, "Informed Consent" obtained, design and performance of experiment procedure is clearly formulated in a protocol - ANSWER What did the Declaration of Helsinki accomplish? 1979 - ANSWER When was the Belmont Report? 1974 - ANSWER When was the National Research Act passed by congress? Boundaries between practice and research? - ANSWER What did the Belmont report establish? Interventions designed solely to enhance well-being of the patient with reasonable expectation of success - ANSWER How does the Belmont Report Define "Practice"? Activity designed to rest a hypothesis, draw a conclusion to develop or contribute to generalized knowledge - ANSWER How does the Belmont Report define "Research"? 1) Respect for persons 2) Beneficience 3)Justice - ANSWER What are the three principles of the Belmont Report? 1) treated as independent agents, those with diminished autonomy are entitled to protection 2) subjects enter into research voluntarily and with adequate information - ANSWER What does "Respect for Persons" entail? 1) Respecting decisions 2) Protecting from harm 3)securing well being: do no harm and maximize benefits while minimizing possible harm - ANSWER What does "Beneficence" entail? 1) Fairness, potential participants should be treated equally 2)Benefit of research not restricted to those who can afford it 3)Research should not involve persons from groups not likely to benefit from application of the research - ANSWER What does "Justice" entail? Informed Consent - ANSWER ICH E6 Section 4.8 Informed consent - ANSWER What must be obtained from the subject or LAR prior to initiating any research related exams? When there is no additional relevant information to provide to the subject? - ANSWER When is the informed consent process over? 1) Statement that includes the nature of the research, the purpose, duration, procedures and experimental procedures 2) Description of risks/discomforts 3) Benefits to the subjects or others 4)Alternative procedures or courses 5) Statement of record confidentiality 6) Compensation 7)Who to contact 8) statement that participation is voluntary - ANSWER What 8 ICF elements are required by 21 CFR 50 1) Risks to embryo or fetus 2) circumstances that might end trial 3)additional costs 4)approximate number of subjects 5)consequences of subject's decision to withdraw historical control - ANSWER What type of controls are commonly used in patient trials? Randomization - ANSWER What is used to avoid subconscious bias in assigning subjects to treatment Blinding - ANSWER What is used to minimize potential subconscious bias in evaluating treatment response? 1)Obtain Med Hx, H&P before enrollment 2) Adverse event monitoring 3) Clinical laboratory tests 4)Special tests like ECG, PFTs, etc - ANSWER What kind safety evaluations are present in protocol and are designed to protect study subjects? Adverse Event - ANSWER What is defined as any untoward medical occurrence occurring in a patient or clinical investigation subject who has been administered an investigational product, does not necessarily have a causal relationship to the treatment? Serious Adverse Event - ANSWER What is defined as any experience that suggests a significant hazard, contraindication, side effect or precaution? 1) Fatal 2)Life-threatening 3)requires or prolongs inpatient hospitalization 3) results in persistent or significant injury 4)A congential anomaly - ANSWER In order to be considered a SAE, the event needs to meet one of the following criteria: Serious and Unexpected - ANSWER The sponsor must notify the FDA and all participating investigators of any adverse events that meet what two criteria? 3 years - ANSWER How long does an IRB retain all relevant records after completion of a trial? 2 Years - ANSWER How long does an investigator retain essential documents? Study Oriented Investigator Oriented - ANSWER What are the two types of FDA Inspections? Routine Triggered by NDA - ANSWER How are study oriented FDA Inspections classified? For Cause or Directed Triggered by data issue, complaint from study subject/staff, publication of results from an ongoing study - ANSWER How are investigator oriented FDA inspections classified? Form 482 - ANSWER What is the FDA Inspection Form? Form 483 - ANSWER What is the FDA form for issuing summary of observations during an inspection? 6th-8th - ANSWER Recommended language level of ICF 1) A Short form Consent document 2) An oral presentation of the required elements of informed consent 3)and IRB approved written summary of what is to be said to the participant or LAR 4)A witness must be present during the oral presentation - ANSWER Four components needed for Short Form Consent 1)Most recent version signed 2) subject signature is present in addition to the subject's namr 3) the subject dated, and is correct 4)Errors corrected per GCP 5) All pages are accounted for - ANSWER ICF Monitoring Ensures what 5 things Immediately - ANSWER When do SAEs need to be reported to Sponsors? 15 Calendar Days - ANSWER When do sponsors need to report SAEs to the FDA? 10 working Days - ANSWER When do sponsors/sites need to report UADE? During the course of the study, and 1 year after completion - ANSWER When are financial disclosures needed? Blinding and randomization - ANSWER What are two common tools to reduce bias? Data Safety Monitoring Board - ANSWER What is a group of experts that reviews research data to ensure subject safety and data validity following plan outlined in the protocol? 1)Oversee the conduct of the trial 2)Protect the rights, safety, and welfare of subjects 3)Control the use of investigational product - ANSWER What are three primary responsibility of investigators? Identification and correction - ANSWER What does QC focus on? Prevention - ANSWER What does QA focus on? CAPA - ANSWER What is a process to identify root cause of issues or problems and actions to resolve them? 15 calendar days - ANSWER Sponsor must submit IND Safety report within what time frame of learning it meets reporting criteria? 7 Calendar days - ANSWER Unexpected fatal or life-threating suspected adverse reactions must be reported by the sponsor in what time frame?