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

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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

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

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

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

Premarket Approval of Medical Devices 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

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

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 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 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

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