SOCRA CCRP Exam Actual Exam 2024: Questions and Answers with Rationales, Exams of Nursing

Download SOCRA CCRP Exam Actual Exam 2024: Questions and Answers with Rationales and more Exams Nursing in PDF only on Docsity!

SOCRA CCRP EXAM ACTUAL EXAM 2024 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES AGRADE 2024. Three vital organ considered highest priority - ANSWER >>>>1) Cardiovascular 2 )Respiratory 3)CNS Types of Non-Clinical Studies (Animal Trials) - ANSWER >>>>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 Primary Pharmacodynamic Studies - ANSWER

Study that investigates the mode of action and/or effects of a drug substance in relation to its desired therapeutic target Secondary Pharmacodynamic Studies - ANSWER Studies that investigate the mode of action and/or

effects of a drug substance not related to its desire therapeutic target Core Battery for Cardiovascular System - ANSWER

Blood Pressure Heart Rate ECG/EKG Repolarization/conductance abnormalities Core Battery for Respiratory System - ANSWER Respiratory Rate Functional Assessments (tidal volume, hgb Oxygen saturation) Core Battery for Central Nervous System - ANSWER Motor activity behavioral changes coordination sensory/motor reflex response temperature 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. • ANSWER >>>>Investigational New Drug Application FDA

An IND permits what? (21 CFR Part 312) - ANSWER

Unapproved drug to be shipped lawfully for the purpose of conducting investigations of the drug FDA's primary objective in all phases of development is... - ANSWER >>>>Assuring the safety and rights of subjects These phase of trials, the FDA helps assure the quality of the scientific evaluation is adequate to permit Study that investigates the mode of action and/or effects of a drug substance in relation to its desired therapeutic target Secondary Pharmacodynamic Studies - ANSWER >>>>Studies that investigate the mode of action and/or effects of a drug substance not related to its desire therapeutic target Core Battery for Cardiovascular System - ANSWER >>>>Blood Pressure Heart Rate ECG/EKG Repolarization/conductance abnormalities Core Battery for Respiratory System - ANSWER >>>>Respiratory Rate Functional Assessments (tidal volume, hgb Oxygen saturation) Core Battery for Central Nervous System - ANSWER >>>>Motor activity behavioral changes coordination sensory/motor reflex response temperature 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) - ANSWER >>>>Investigational New Drug Application FDA An IND permits what? (21 CFR Part 312) - ANSWER >>>>Unapproved drug to be shipped lawfully for the purpose of conducting investigations of the drug FDA's primary objective in all phases of development is... - ANSWER >>>>Assuring the safety and rights of subjects These 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) - ANSWER >>>>Phase II and III Who determines if Phase II/III studies are likely to yield data capable of meeting regulatory standards for marketing approval? - ANSWER >>>>The FDA IND information depends on the amount of information available, these 4 things are: (21 CFR Part 312) - ANSWER >>>>1) Novelty of drug 2)Extent the drug has been studied previously

3. Known of suspected risks
4. Phase of development Initial IND should focus on (21 CFR Part 312) - ANSWER >>>>General Investigational Plan Protocols for specific human studies

Amendments to IND with new or revised protocols ( CFR Part 312) - ANSWER >>>>Build logically on previous submissions Be supported by additional information such as animal studies and other human studies A Sponsor Initiated IND must contain (21 CFR Part 312 ) - ANSWER >>>>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 How long does it take for an IND to go into effect? ( CFR Part 312) - ANSWER >>>>30 Days, unless FDA notifies sponsor of clinical hold Upon earlier notification, investigations may begin The purpose of Treatment Use of Investigational Drug (21 CFR Part 312) - ANSWER >>>>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

A treatment protocol or IND may be filed if: ((21 CFR Part 312) - ANSWER >>>>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 A treatment protocol or IND are usually found in what phase of trials? - ANSWER >>>>Phase II/ III trials or 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 How long is the waiting period before the study can initiate after the treatment IND is submitted? - ANSWER >>>>30-Day Waiting Period Emergency use of an investigational product (21 CFR Part 312) - ANSWER >>>>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

How quickly must a site notify the IRB of an emergency use of investigational drug? (21 CFR Part 312) - ANSWER >>>>5 Working Days Sponsors have the right with withdraw an IND at anytime, without prejudice by completing the following: (21 CFR Part 312) - ANSWER >>>>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 What is a "Clinical Hold" - ANSWER >>>>An order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation What does a FDA "Clinical Hold" mean for a proposed study? - ANSWER >>>>Subjects may not be given the investigational drug What does a FDA "Clinical Hold" mean for an ongoing study? - ANSWER >>>>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

Grounds for FDA Clinical Hold in Phase 1 Trials - ANSWER >>>>1) 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 Grounds for FDA Clinical Hold in Phase II/III Trials - ANSWER >>>>1) All grounds related to holds in Phase 1 trials AND

2. The protocol is clearly deficient in design to meet the stated objects Types of Phase I Trials - ANSWER >>>>1) Initial Safety, dose escalation studies to determine MTD
3. PK and PD property, might be cross over design
4. Absorption, distribution, metabolism and excretion studies
5. Efficacy assessment, if possible Goals of Phase II Trials - ANSWER >>>>1) Initial demonstration of efficacy in subjects with the condition under investigation
6. obtain short term safety Goals of Phase III trials - ANSWER >>>>1) Confirmation of short term efficacy and safety

2. Establish long term efficacy and safety
3. Assess overall therapeutic value What phase of study usually has the largest number of subjects per study? - ANSWER >>>>Phase III What phase of study is usually single-center? - ANSWER >>>>Phase I What phases of stuides are usually multicenter? - ANSWER >>>>Phase II/III Goals of Phase IV Trials - ANSWER >>>>1) Address FDA requirements for additional information not in NDA
4. Continue to assess overall therapeutic value 3)Surveillance for less common adverse events What year was the Medical Device Amendment? - ANSWER >>>> 21 CFR Part 803 - ANSWER >>>>Medical Device Reporting 21 CFR Part 812 - ANSWER >>>>Investigational Device Exemption 21 CFR Part 814 - ANSWER >>>>Premarket Approval of Medical Devices

21 CFR Part 820 - ANSWER >>>>Quality System Regulations 21 CFR Part 860 - ANSWER >>>>Medical Device Classification Procedures Device definitions excludes what 2 type of products - ANSWER >>>>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 When was 510K Clearance Established? - ANSWER

1976, With Medical Device Amendments What is a 510k? - ANSWER >>>>Clearance Pre-Market Approval Requirements - ANSWER >>>>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 How do you define Class I Devices? - ANSWER

Lowest Risk, 510K often not required How are devices distinguished by risk? - ANSWER Class I, II, III

How do you define a device with Class II risk? - ANSWER >>>>Moderate risk, usually requires 510k, might require PMA How do you define a device with Class III risk? - ANSWER >>>>Highest risk, PMA required Examples of Class I devices - ANSWER >>>>Elastic bandages, exam gloves, hand-held surgical instruments What are the general controls that provide reasonable assurance of safety for a device? - ANSWER >>>>1) Prohibition against adulterated or misbranded devices

2. Premarket notification 510k requirements
3. GMPs
4. Registration of manufacturing facilities 5 ) listing of device types What type of device is sufficiently assured by general device controls? - ANSWER >>>>Class I In addition to general controls, Class II devices are also subject to these types of special controls - ANSWER

1. Special labeling requirements

2. mandatory performance standards
3. post-market surveilance

Class III Devices Descriptions - ANSWER >>>>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 Examples of Class III Drugs - ANSWER

Replacement heart valve silicone-gel filled breast implants implanted cerebella stimulators implantable pacemakeres Examples of Class II devices - ANSWER >>>>Powered wheel chairs infusion pumps surgical drapes How is risk determined in device studies? - ANSWER Determined by the nature of the harm that may result to the subject in the study A Significant Risk (SR) Device Study is defined as: - ANSWER >>>>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 How do you define a non-significant risk device study?

• ANSWER >>>>Does not meet the criteria for significant risk Who makes the initial determination of SR or NSR? - ANSWER >>>>The sponsor, the IRB evaluates the determination IRB definition of Minimal Risk - ANSWER >>>>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 What type of device studies are subject to all IDE regulations (21 CFR Part 812) - ANSWER

Significant Risk Trials Replacement heart valve silicone-gel filled breast implants implanted cerebella stimulators implantable pacemakeres Examples of Class II devices - ANSWER >>>>Powered wheel chairs infusion pumps surgical drapes How is risk determined in device studies? - ANSWER >>>>Determined by the nature of the harm that may result to the subject in the study A Significant Risk (SR) Device Study is defined as: - ANSWER >>>>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 How do you define a non-significant risk device study? - ANSWER >>>>Does not meet the criteria for significant risk Who makes the initial determination of SR or NSR? - ANSWER >>>>The sponsor, the IRB evaluates the determination IRB definition of Minimal Risk - ANSWER >>>>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 What type of device studies are subject to all IDE regulations (21 CFR Part 812) - ANSWER >>>>Significant Risk Trials What type of device studies are subject to abbreviated IDE regulations? (21 CFR Part 812.2b) - ANSWER Non-significant risk trials Types of Device Trials - ANSWER >>>>Pilot Study Pivotal Study

What does an Investigational Device Exemption (IDE) permit? - ANSWER >>>>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 Devices can be granted IDE if: - ANSWER

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 Definition of Unanticipated adverse device effect - ANSWER >>>>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
6. any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects

What is the SAE counterpart in device trials? - ANSWER >>>>Unanticipated adverse device effect (UADE) What is used in device studies instead of a 1572? - ANSWER >>>>Investigational agreement What 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? - ANSWER >>>>5 Working Days, IRB and sponsor What timeframe and to whom do investigators have to report UADEs? - ANSWER >>>>10 Working Days, Sponsor and reviewing IRB Notification time requirement for emergency use of investigational device - ANSWER >>>>5 Working Days (Sponsor and IRB) Who is responsible fore maintaining an effective IND or IDE? - ANSWER >>>>Sponsor Who is responsible for ensuring all investigators are conducting studies according to the general investigational plan and protocols in the IND? - ANSWER >>>>Sponsor

Who is responsible for promptly reporting information about significant new adverse events or unanticipated adverse device effect with respect to the investigational product? - ANSWER >>>>Sponsor Who is responsible to terminate all studies if the product presents an unreasonable and significant risk to study subjects? - ANSWER >>>>Sponsor Who is responsible for selecting qualified investigators?

• ANSWER >>>>Sponsor Who is responsible for providing information needed to conduct the study? - ANSWER >>>>Sponosr Who is responsible for selecting qualified monitors? - ANSWER >>>>Sponsor What are three types of monitoring the sponsor is responsible for? - ANSWER >>>>1) Medical Monitor

2. Data Safety Monitoring Boards
3. On-site monitoring Who is responsible for clinical oversight, evaluating safety information-trial wide? - ANSWER >>>>Sponsor Medical Monitor

Who is responsible for periodic review of study data while study is in progress? - ANSWER >>>>Data Safety Monitoring Board Who is responsible for periodic site visits? - ANSWER

On-Site Monitors What are SPONSOR responsibilities with regard to IP?

• ANSWER >>>>1) Manufacturing, packaging, labeling and coding of the investigational drug

2. 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 What documents must be obtained from an investigator prior to study start? - ANSWER >>>>1) Signed 1572 or investigational agreement 2)CV 3)Protocol
3. Financial disclosure Who is responsible for submitting safety reports to sites? - ANSWER >>>>Sponsor Who is responsible with providing pre-clinical and clinical study reports in the information amendments to the IND? - ANSWER >>>>Sponsor

Who has the responsibility in submitting an annual report to the IND/IDE? - ANSWER >>>>Sponsor Who has the responsibility in maintaining quality assurance and quality control systems, with SOPs, for all activities? - ANSWER >>>>Sponsor Who has the responsibility to ensure the study is designed by qualified individuals? - ANSWER

Sponsor Who has the responsibility to obtain an agreement from the investigator to adhere to the protocol, obtain IRB approval and GCP compliance? - ANSWER Sponsor Who is required to notify all parties involved, if warranted, of new safety information adversely affecting subject safety? - ANSWER >>>>Sponsor When do sponsors have to submit summary forms of financial disclosures to the FDA? - ANSWER During Marketing Applications What are 4 types of financial disclosures? - ANSWER

1. 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

3. Proprietary interest in tested product
4. Significant payments of other sorts to investigator or institution supporting activities of investigator What is the $ reportable amount for a financial disclosure if the amount is based on study outcome? - ANSWER >>>>All amounts What is the $ reported amount for a financial disclosure for proprietary interest in the test product? - ANSWER

All amounts What is the $ reported amount for a financial disclosure for equity interest in the sponsor? - ANSWER >>>>All amounts What is the $ reported amount for a financial disclosure for equity interest in a publicly traded company? - ANSWER >>>>>$50, What is the $ reported amount for a financial disclosure for significant payments? - ANSWER >>>>>$25, Who may the sponsor transfer responsibility of duties or functions? - ANSWER >>>>Contract Research Organization ICH E6, Section 5.18 - ANSWER >>>>Monitor Responsibilties

What are the primary purposes for study monitoring? - ANSWER >>>>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 Written monitoring reports should include what elements? - ANSWER >>>>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 21 CFR 312.60- 70 - ANSWER >>>>Investigator Responsibilities ICH E6 Section 4 - ANSWER >>>>Investigator Responsibilities What form documents investigator agreement to investigator responsibilities in drug trials? - ANSWER

21 CFR Part 312.62 - ANSWER >>>>Maintain adequate and accurate records Investigator responsibilitiy 21 CFR Part 312.68 - ANSWER >>>>Make study records available for inspection Drug accountability records should contain: - ANSWER

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 How should source document corrections be made according to GCP guidelines? - ANSWER >>>>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 When was the Nuremberg code developed? - ANSWER >>>> What did the Nuremberg code establish? - ANSWER

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
4. proper facilities and preparation 8)conducted by qualified individuals 9)freedom to withdraw consent When was the Declaration of Helsinki? - ANSWER

1964 What did the Declaration of Helsinki accomplish? - ANSWER >>>>Reiterated Nuremberg Code, "Informed Consent" obtained, design and performance of Maintain adequate and accurate records Investigator responsibilitiy 21 CFR Part 312.68 - ANSWER >>>>Make study records available for inspection Drug accountability records should contain: - ANSWER >>>>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 How should source document corrections be made according to GCP guidelines? - ANSWER >>>>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 When was the Nuremberg code developed? - ANSWER >>>> What did the Nuremberg code establish? - ANSWER >>>>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 When was the Declaration of Helsinki? - ANSWER >>>>1964 What did the Declaration of Helsinki accomplish? - ANSWER >>>>Reiterated Nuremberg Code, "Informed Consent" obtained, design and performance of experiment procedure is clearly formulated in a protocol When was the Belmont Report? - ANSWER >>>>1979 When was the National Research Act passed by congress? - ANSWER >>>>1974 What did the Belmont report establish? - ANSWER Boundaries between practice and research? How does the Belmont Report Define "Practice"? - ANSWER >>>>Interventions designed solely to

enhance well-being of the patient with reasonable expectation of success How does the Belmont Report define "Research"? - ANSWER >>>>Activity designed to rest a hypothesis, draw a conclusion to develop or contribute to generalized knowledge What are the three principles of the Belmont Report? - ANSWER >>>>1) Respect for persons

2. Beneficience 3)Justice What does "Respect for Persons" entail? - ANSWER

1. treated as independent agents, those with diminished autonomy are entitled to protection

2. subjects enter into research voluntarily and with adequate information What does "Beneficence" entail? - ANSWER >>>>1) Respecting decisions
3. Protecting from harm 3)securing well being: do no harm and maximize benefits while minimizing possible harm What does "Justice" entail? - ANSWER >>>>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 ICH E6 Section 4.8 - ANSWER >>>>Informed Consent What must be obtained from the subject or LAR prior to initiating any research related exams? - ANSWER

Informed consent When is the informed consent process over? - ANSWER >>>>When there is no additional relevant information to provide to the subject? What 8 ICF elements are required by 21 CFR 50 - ANSWER >>>>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

What additional elements can be included in an ICF, but not required? - ANSWER >>>>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 6)significant new finding statement What cannot contain language that waives or appears to waive the rights of the subject? - ANSWER >>>>The Informed Consent Form What cannot include language that releases or appears to release investigator, institution, sponsor or their agents from liability for negligence? - ANSWER

The Informed Consent Form When does the subject have the right to ask questions about the study? - ANSWER >>>>The Informed Consent Process 21 CFR Part 50 only requires who to sign the ICF? - ANSWER >>>>The subject only ICH E6 guidelines requires who to sign the ICF? - ANSWER >>>>Subject and person conducting the consent process

When must patient's be reconsented? - ANSWER

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 What are the goals of an IRB? (21 CFR Part 56) -

ANSWER >>>>To safeguard rights, safety and well being of all trial subjects To pay special attention to trials that may include vulnerable subjects What is the minimum member requirement for an IRB?

• ANSWER >>>>5 How should an IRB be comprised? - ANSWER

Varied backgrounds, diversity and expertise 1 member with scientific expertise 1 member with nonscientific concern 1 member not affiliated with insitution Who may assist the IRB in review and determinations, but not vote? - ANSWER >>>>Experts What populations are more likely to be a vulnerable subject? - ANSWER >>>>1) Prisoners

2. Pregnant women, children 3)Handicapped 4)mentally disabled 5)economically or educationally disadvantaged