SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND ANSWERS 2025, Exams of Nursing

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1 SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND ANSWERS 2025 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

2 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

3 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: ( 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

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 5

unless continuation is specifically permitted by the FDA

7 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

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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

2. 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

How are devices distinguished by risk? - ANSWER

Class I, II, III

10 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

3. is of substantial importance in diagnosing, curing, mitigating or treating disease or other prevents impairment of human health

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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