SOCRA CCRP Exam Questions and Answers with Rationales 2024-2025, Exams of Health sciences

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SOCRA CCRP Exam ACTUAL EXAM

QUESTIONS & Verified ANSWERS WITH

RATIONALES 2024-2025|GRADED A

$25,000 - ANSWhat is the $ reported amount for a financial disclosure for significant payments? $50,000 - ANSWhat is the $ reported amount for a financial disclosure for equity interest in a publicly traded company?

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 - ANSFour components needed for Short Form Consent
3. Achieve their primary intended purpose through chemical action within the body
4. Are dependent upon being metabolized for the primary achievement of the primary intended purpose - ANSDevice definitions excludes what 2 type of products
5. Address FDA requirements for additional information not in NDA
6. Continue to assess overall therapeutic value 3)Surveillance for less common adverse events - ANSGoals of Phase IV Trials
7. All grounds related to holds in Phase 1 trials AND
8. The protocol is clearly deficient in design to meet the stated objects - ANSGrounds for FDA Clinical Hold in Phase II/III Trials
9. Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a device

[Date] 2)if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application

2. any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects - ANSDefinition of Unanticipated adverse device effect
3. Approval
4. Modifications needed
5. Disapproval - ANSWhat are the 3 outcomes of IRB review?
6. Are usually those that support or sustain human life
7. are of substantial importance in preventing the impairment of human health 3)Present a potential, unreasonable risk of illness or injury - ANSClass III Devices Descriptions
8. Cardiovascular 2)Respiratory 3)CNS - ANSThree vital organ considered highest priority
9. Compensation affected by study outcome or in the form of equity interest in sponsor or compensation tied to sales 2)Significant equity interest in sponsor
10. Proprietary interest in tested product
11. Significant payments of other sorts to investigator or institution supporting activities of investigator - ANSWhat are 4 types of financial disclosures?
12. Confirmation of short term efficacy and safety
13. Establish long term efficacy and safety
14. Assess overall therapeutic value - ANSGoals of Phase III trials
15. 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 - ANSWhat does "Justice" entail?
16. Fatal 2)Life-threatening 3)requires or prolongs inpatient hospitalization

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3. results in persistent or significant injury 4)A congential anomaly - ANSIn order to be considered a SAE, the event needs to meet one of the following criteria:
4. 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 - ANSA Significant Risk (SR) Device Study is defined as:
5. Initial demonstration of efficacy in subjects with the condition under investigation
6. obtain short term safety - ANSGoals of Phase II Trials
7. Initial Safety, dose escalation studies to determine MTD
8. PK and PD property, might be cross over design
9. Absorption, distribution, metabolism and excretion studies
10. Efficacy assessment, if possible - ANSTypes of Phase I Trials
11. Inventory of product received by site, and date
12. Dispensing and return information for each subject 3)Specific protocol information like batch numbers, expiration dates, serial numbers, unique codes assigned to trial subjects - ANSDrug accountability records should contain:
13. Manufacturing, packaging, labeling and coding of the investigational drug
14. Providing the investigational product only to investigators participating in an investigation 3)Maintain drug and device accountability records from manufacturing through use, return and destruction - ANSWhat are SPONSOR responsibilities with regard to IP?
15. Medical Monitor
16. Data Safety Monitoring Boards
17. On-site monitoring - ANSWhat are three types of monitoring the sponsor is responsible for?

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1. Notifying the FDA
2. Stopping all studies and notifying the investigators 3)All drug returned to the sponsor or destroyed as directed by sponsor 4)If withdrawn due to safety reasons, the sponsor must notify the investigators and the IRBs of those reasons - ANSSponsors have the right with withdraw an IND at anytime, without prejudice by completing the following: (21 CFR Part 312)
3. Novelty of drug 2)Extent the drug has been studied previously
4. Known of suspected risks
5. Phase of development - ANSIND information depends on the amount of information available, these 4 things are: (21 CFR Part 312)
6. PK and toxicokinetic
7. Single dose toxicity
8. Repeated dose toxicity
9. Local tolerance
10. Genotoxicity
11. Carcinogenicity
12. Reproduction toxicity
13. Supplemental studies if needed - ANSTypes of Non-Clinical Studies (Animal Trials)
14. Prisoners
15. Pregnant women, children 3)Handicapped 4)mentally disabled 5)economically or educationally disadvantaged - ANSWhat populations are more likely to be a vulnerable subject?
16. Prohibition against adulterated or misbranded devices
17. Premarket notification 510k requirements
18. GMPs
19. Registration of manufacturing facilities
20. listing of device types - ANSWhat are the general controls that provide reasonable assurance of safety for a device?
21. Protocol and amendments
22. ICF

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3. Subject recruitment materials (ads)
4. IB 5)Available safety data
5. Information about payments/compensation to subjets 7)Current CV of Investigators - ANSWhat documents need to be submitted to the IRB?
6. Required process of scientific review to ensure the reasonable safety and effectiveness of medical devices
7. FDA approval required before the device can be legally marketed - ANSPre-Market Approval Requirements
8. Respect for persons
9. Beneficience 3)Justice - ANSWhat are the three principles of the Belmont Report?
10. Respecting decisions
11. Protecting from harm 3)securing well being: do no harm and maximize benefits while minimizing possible harm - ANSWhat does "Beneficence" entail?
12. Risks to embryo or fetus
13. circumstances that might end trial 3)additional costs 4)approximate number of subjects 5)consequences of subject's decision to withdraw 6)significant new finding statement - ANSWhat additional elements can be included in an ICF, but not required?
14. Signed 1572 or investigational agreement 2)CV 3)Protocol
15. Financial disclosure - ANSWhat documents must be obtained from an investigator prior to study start?
16. Special labeling requirements
17. mandatory performance standards
18. post-market surveilance - ANSIn addition to general controls, Class II devices are also subject to these types of special controls

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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
4. Statement of record confidentiality
5. Compensation 7)Who to contact
6. statement that participation is voluntary - ANSWhat 8 ICF elements are required by 21 CFR 50
7. Subjects enrolled
8. Summary
9. Number of withdrawals 4)Reason for withdrawals 5)Research results thus far
10. Current risk/benefit assessment 7)any new information since last review - ANSIRB Progress Reports should include what elements?
11. Subjects exposed to unreasonable risk, illness or injury 2)Clinical investigators are not qualified 3)Investigator's brochure is misleading, inaccurate or materially incomplete 4)The IND does not contain sufficient information to assess risk to subjects

• ANSGrounds for FDA Clinical Hold in Phase 1 Trials

1. The drug is intended to treat a serious or immediately life threatening disease
2. No comparable or satisfactory alternative drug/therapy is available to treat the stage of disease in the intended patient population - ANSA treatment protocol or IND may be filed if: ((21 CFR Part 312)
3. The investigator's name and site location
4. date of the visit
5. monitor's name
6. site personell contacted 5)summary of what information was reviewed 6)significant findings and corrective action - ANSWritten monitoring reports should include what elements?

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1. To facilitate the availability of promising new drugs available to desperately ill patients as early in the drug development process as possible, before general marketing begins 2)To obtain additional data on the drug's safety and effectiveness - ANSThe purpose of Treatment Use of Investigational Drug (21 CFR Part
3. To Identify undesirable PD properties of a substance that may have relevance to its human safety.
4. 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 - ANSDrug Development Safety Pharmacology Study Objectives (3)
5. treated as independent agents, those with diminished autonomy are entitled to protection
6. subjects enter into research voluntarily and with adequate information - ANSWhat does "Respect for Persons" entail?
7. 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 - ANSWhat are the primary purposes for study monitoring?
8. Voluntary consent
9. Fruitful results
10. 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
11. proper facilities and preparation 8)conducted by qualified individuals 9)freedom to withdraw consent - ANSWhat did the Nuremberg code establish? 1)Legally marketable device in accordance with its labeling

[Date] 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 - ANSDevices can be granted IDE if: 1)Most recent version signed
6. subject signature is present in addition to the subject's namr
7. the subject dated, and is correct 4)Errors corrected per GCP
8. All pages are accounted for - ANSICF Monitoring Ensures what 5 things 1)Obtain Med Hx, H&P before enrollment
9. Adverse event monitoring
10. Clinical laboratory tests 4)Special tests like ECG, PFTs, etc - ANSWhat kind safety evaluations are present in protocol and are designed to protect study subjects? 1)Oversee the conduct of the trial 2)Protect the rights, safety, and welfare of subjects 3)Control the use of investigational product - ANSWhat are three primary responsibility of investigators? 10 working Days - ANSWhen do sponsors/sites need to report UADE? 10 Working Days, Sponsor and reviewing IRB - ANSWhat timeframe and to whom do investigators have to report UADEs? 15 calendar days - ANSSponsor must submit IND Safety report within what time frame of learning it meets reporting criteria? 15 Calendar Days - ANSWhen do sponsors need to report SAEs to the FDA? 1572 - ANSWhat form documents investigator agreement to investigator responsibilities in drug trials? 1947 - ANSWhen was the Nuremberg code developed?

[Date] 1964 - ANSWhen was the Declaration of Helsinki? 1974 - ANSWhen was the National Research Act passed by congress? 1976 - ANSWhat year was the Medical Device Amendment? 1976, With Medical Device Amendments - ANSWhen was 510K Clearance Established? 1979 - ANSWhen was the Belmont Report? 2 Years - ANSHow long does an investigator retain essential documents? 21 CFR Part 814 - ANSpre market approval of medical devices 3 years - ANSHow long does an IRB retain all relevant records after completion of a trial? 30 Days, unless FDA notifies sponsor of clinical hold Upon earlier notification, investigations may begin - ANSHow long does it take for an IND to go into effect? (21 CFR Part 312) 30-Day Waiting Period - ANSHow long is the waiting period before the study can initiate after the treatment IND is submitted? 45 CFR Part 46 - ANSFederal Research 5 - ANSWhat is the minimum member requirement for an IRB? 5 Working Days - ANSHow quickly must a site notify the IRB of an emergency use of investigational drug? (21 CFR Part 312) 5 Working Days (Sponsor and IRB) - ANSNotification time requirement for emergency use of investigational device 5 Working Days, IRB and sponsor - ANSWhat time frame and to whom do sites have to report deviations from investigational plan in order to protect life or well being of patients on device trials?

[Date] 6th-8th - ANSRecommended language level of ICF 7 Calendar days - ANSUnexpected fatal or life-threating suspected adverse reactions must be reported by the sponsor in what time frame? A Progress Report - ANSIn order to conduct a continuing review, IRBs require what document? Activity designed to rest a hypothesis, draw a conclusion to develop or contribute to generalized knowledge - ANSHow does the Belmont Report define "Research"? Adverse Event - ANSWhat 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? All amounts - ANSWhat is the $ reportable amount for a financial disclosure if the amount is based on study outcome? All amounts - ANSWhat is the $ reported amount for a financial disclosure for equity interest in the sponsor? All amounts - ANSWhat is the $ reported amount for a financial disclosure for proprietary interest in the test product? An order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation - ANSWhat is a "Clinical Hold" April 30 1996 - ANSICH GCP Development Date Assuring the safety and rights of subjects - ANSFDA's primary objective in all phases of development is... Blinding - ANSWhat is used to minimize potential subconscious bias in evaluating treatment response? Blinding and randomization - ANSWhat are two common tools to reduce bias?

[Date] Blood Pressure Heart Rate ECG/EKG Repolarization/conductance abnormalities - ANSCore Battery for Cardiovascular System Boundaries between practice and research? - ANSWhat did the Belmont report establish? Build logically on previous submissions Be supported by additional information such as animal studies and other human studies - ANSAmendments to IND with new or revised protocols ( CFR Part 312) CAPA - ANSWhat is a process to identify root cause of issues or problems and actions to resolve them? Class I - ANSWhat type of device is sufficiently assured by general device controls? Class I, II, III - ANSHow are devices distinguished by risk? Clearance - ANSWhat is a 510k? Clinical Safety Data Management Definitions and Standards - ANSICH E2A Contract Research Organization - ANSWho may the sponsor transfer responsibility of duties or functions? Cover Sheet (FDA Form 1571) Table of Contents Introductory statement investigator's brochure protocol (s) Chemistry and manufacturing information pharm and tox information previous human experience with investigational drug - ANSA Sponsor Initiated IND must contain (21 CFR Part 312)

[Date] Data Safety Monitoring Board - ANSWhat is a group of experts that reviews research data to ensure subject safety and data validity following plan outlined in the protocol? Data Safety Monitoring Board - ANSWho is responsible for periodic review of study data while study is in progress? Determined by the nature of the harm that may result to the subject in the study - ANSHow is risk determined in device studies? Does not meet the criteria for significant risk - ANSHow do you define a non-significant risk device study? Dose Escalation (tolerance) Crossover (Bioequivalence) Parallel Group (efficacy and safety) Dose Range (Multiple doses, usually placebo controlled) Uncontrolled (Long term expansion studies) - ANS5 Common Study Designs During Marketing Applications - ANSWhen do sponsors have to submit summary forms of financial disclosures to the FDA? During the course of the study, and 1 year after completion - ANSWhen are financial disclosures needed? Efficacy - ANSICH E Elastic bandages, exam gloves, hand-held surgical instruments - ANSExamples of Class I devices Electronic records, electronic signatures - ANS21 CFR Part 11 Expedited review - ANSWhat kind of review can be used for minor changes in previously approved research? Experts - ANSWho may assist the IRB in review and determinations, but not vote? Financial Disclosures - ANS21 CFR Part 54

[Date] For Cause or Directed Triggered by data issue, complaint from study subject/staff, publication of results from an ongoing study - ANSHow are investigator oriented FDA inspections classified? Form 482 - ANSWhat is the FDA Inspection Form? Form 483 - ANSWhat is the FDA form for issuing summary of observations during an inspection? General Investigational Plan Protocols for specific human studies - ANSInitial IND should focus on ( CFR Part 312) guidance for industry, consolidated guideance - ANSICH E 6 Health and Human Services - ANSHow is HHS defined? HHS Regulations for Protection of Human Subjects - ANS45 CFR Part 46 Highest risk, PMA required - ANSHow do you define a device with Class III risk? Identification and correction - ANSWhat does QC focus on? If the changes in the research trial affect the treatment of the subject, or may affect the subject's willingness to continue in the study - ANSWhen must patient's be reconsented? If the research is funded in whole or part by HHS and regulated by the FDA

• ANSWhen is research regulated by both FDA and HHS? Immediately - ANSWhen do SAEs need to be reported to Sponsors? IND Application - ANS21 CFR 312 Informed Consent - ANS21 CFR Part 50 Informed Consent - ANSICH E6 Section 4.

[Date] Informed consent - ANSWhat must be obtained from the subject or LAR prior to initiating any research related exams? Institutional Review Board - ANS21 CFR Part 56 Interventions designed solely to enhance well-being of the patient with reasonable expectation of success - ANSHow does the Belmont Report Define "Practice"? Investigational agreement - ANSWhat is used in device studies instead of a 1572? Investigational Device Exemption - ANS21 CFR 812 Investigational Device Exemption - ANS21 CFR Part 812 Investigational New Drug Application FDA - ANSBefore 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) Investigator Responsibilities - ANS21 CFR 312.60- Investigator Responsibilities - ANSICH E6 Section 4 Lowest Risk, 510K often not required - ANSHow do you define Class I Devices? Maintain adequate and accurate records Investigator responsibilitiy - ANS21 CFR Part 312. Make study records available for inspection - ANS21 CFR Part 312. Medical Device Classification Procedures - ANS21 CFR Part 860 Medical Device Reporting - ANS21 CFR Part 803 Moderate risk, usually requires 510k, might require PMA - ANSHow do you define a device with Class II risk?

[Date] Monitor Responsibilties - ANSICH E6, Section 5. Motor activity behavioral changes coordination sensory/motor reflex response temperature - ANSCore Battery for Central Nervous System Multidisciplinary - ANSICH M Need for investigational drug arises in an emergency situation Insufficient time to allow for submission of an IND or a treatment IND Request for specified use by telephone or other rapid means of communication - ANSEmergency use of an investigational product (21 CFR Part 312) New Drug Application - ANS21 CFR 314 no new subjects may be given the IP and subjects already taking the drug should be discontinued unless continuation is specifically permitted by the FDA - ANSWhat does a FDA "Clinical Hold" mean for an ongoing study? Non-significant risk trials - ANSWhat type of device studies are subject to abbreviated IDE regulations? (21 CFR Part 812.2b) Not less than once a year Appropriate for the risk involved Review must be done prior to current expiration - ANSContinuing review must be conducted how often? On-Site Monitors - ANSWho is responsible for periodic site visits? Phase I - ANSWhat phase of study is usually single-center? Phase II and III - ANSThese phase of trials, the FDA helps assure the quality of the scientific evaluation is adequate to permit evaluation of the drugs safety and efficacy (21 CFR Part 312) Phase II/ III trials or

[Date] After all the clinical trials have been completed and the sponsor of the controlled clinical trial is actively pursuing marketing approval of the drug with due dilligence - ANSA treatment protocol or IND are usually found in what phase of trials? Phase II/III - ANSWhat phases of stuides are usually multicenter? Phase III - ANSWhat phase of study usually has the largest number of subjects per study? Pilot Study Pivotal Study - ANSTypes of Device Trials Placebo controlled dose-comparison concurrent control no-treatment concurrent control active-treatment concurrent control historical control - ANSWhat type of controls are commonly used in patient trials? Powered wheel chairs infusion pumps surgical drapes - ANSExamples of Class II devices Premarket Approval of Medical Devices - ANS21 CFR Part 814 Prevention - ANSWhat does QA focus on? Quality - ANSICH Q Quality System Regulations - ANS21 CFR Part 820 Randomization - ANSWhat is used to avoid subconscious bias in assigning subjects to treatment Reiterated Nuremberg Code, "Informed Consent" obtained, design and performance of experiment procedure is clearly formulated in a protocol - ANSWhat did the Declaration of Helsinki accomplish? Replacement heart valve

[Date] silicone-gel filled breast implants implanted cerebella stimulators implantable pacemakeres - ANSExamples of Class III Drugs Respiratory Rate Functional Assessments (tidal volume, hgb Oxygen saturation) - ANSCore Battery for Respiratory System Routine Triggered by NDA - ANSHow are study oriented FDA Inspections classified? Safety - ANSICH S Safety pharmacology studies for human pharmaceuticals - ANSICH S7A Serious Adverse Event - ANSWhat is defined as any experience that suggests a significant hazard, contraindication, side effect or precaution? Serious and Unexpected - ANSThe sponsor must notify the FDA and all participating investigators of any adverse events that meet what two criteria? Significant Risk Trials - ANSWhat type of device studies are subject to all IDE regulations (21 CFR Part 812) 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 - ANSHow should source document corrections be made according to GCP guidelines? Sponosr - ANSWho is responsible for providing information needed to conduct the study? Sponsor - ANSWho has the responsibility in maintaining quality assurance and quality control systems, with SOPs, for all activities?

[Date] Sponsor - ANSWho has the responsibility in submitting an annual report to the IND/IDE? Sponsor - ANSWho has the responsibility to ensure the study is designed by qualified individuals? Sponsor - ANSWho has the responsibility to obtain an agreement from the investigator to adhere to the protocol, obtain IRB approval and GCP compliance? Sponsor - ANSWho is required to notify all parties involved, if warranted, of new safety information adversely affecting subject safety? Sponsor - ANSWho is responsible for ensuring all investigators are conducting studies according to the general investigational plan and protocols in the IND? Sponsor - ANSWho is responsible for promptly reporting information about significant new adverse events or unanticipated adverse device effect with respect to the investigational product? Sponsor - ANSWho is responsible for selecting qualified investigators? Sponsor - ANSWho is responsible for selecting qualified monitors? Sponsor - ANSWho is responsible for submitting safety reports to sites? Sponsor - ANSWho is responsible fore maintaining an effective IND or IDE? Sponsor - ANSWho is responsible to terminate all studies if the product presents an unreasonable and significant risk to study subjects? Sponsor - ANSWho is responsible with providing pre-clinical and clinical study reports in the information amendments to the IND? Sponsor Medical Monitor - ANSWho is responsible for clinical oversight, evaluating safety information-trial wide?

[Date] Studies that investigate the mode of action and/or effects of a drug substance not related to its desire therapeutic target - ANSSecondary Pharmacodynamic Studies Studies that investigate the potential undesirable PD effects of a substance on physiological functions in relation to exposure in the therapeutic range or above - ANSSafety Pharmacology Studies (Pre-Clinical) Study Oriented Investigator Oriented - ANSWhat are the two types of FDA Inspections? Study that investigates the mode of action and/or effects of a drug substance in relation to its desired therapeutic target - ANSPrimary Pharmacodynamic Studies Subject and person conducting the consent process - ANSICH E guidelines requires who to sign the ICF? Subjects may not be given the investigational drug - ANSWhat does a FDA "Clinical Hold" mean for a proposed study? The FDA - ANSWho determines if Phase II/III studies are likely to yield data capable of meeting regulatory standards for marketing approval? The Informed Consent Form - ANSWhat cannot contain language that waives or appears to waive the rights of the subject? The Informed Consent Form - ANSWhat cannot include language that releases or appears to release investigator, institution, sponsor or their agents from liability for negligence? The Informed Consent Process - ANSWhen does the subject have the right to ask questions about the study? 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 - ANSIRB definition of Minimal Risk

[Date] 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 - ANSWhat does an Investigational Device Exemption (IDE) permit? The sponsor, the IRB evaluates the determination - ANSWho makes the initial determination of SR or NSR? The subject only - ANS21 CFR Part 50 only requires who to sign the ICF? To safeguard rights, safety and well being of all trial subjects To pay special attention to trials that may include vulnerable subjects - ANSWhat are the goals of an IRB? (21 CFR Part 56) Unanticipated adverse device effect (UADE) - ANSWhat is the SAE counterpart in device trials? Unapproved drug to be shipped lawfully for the purpose of conducting investigations of the drug - ANSAn IND permits what? (21 CFR Part 312) Varied backgrounds, diversity and expertise 1 member with scientific expertise 1 member with nonscientific concern 1 member not affiliated with insitution - ANSHow should an IRB be comprised? When there is no additional relevant information to provide to the subject? - ANSWhen is the informed consent process over?