SOCRA CCRP exam questions and answers already graded A+| Updated & Verified | 2024, Exams of Pharmacy

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SOCRA CCRP exam questions and answers

already graded A+| Updated & Verified | 2024

Timeline of Historical Events - ✔✔Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - ✔✔respect for persons, beneficence, justice Application of Respect for Persons - ✔✔informed consent (autonomy, choose for themselves) Application of Beneficence - ✔✔risk/benefit analysis Application of Justice - ✔✔appropriate selection of patients (equality) Language Level ICF - ✔✔6th-8th grade 8 basic elements of ICF - ✔✔1. purpose, duration, and procedures

2. risks/discomforts
3. benefits
4. alternatives
5. confidentiality
6. compensation/medical treatments injury
7. contact information

8. voluntary participation and discontinuation at any time Long ICF - ✔✔standard consent form Short ICF - ✔✔a document that elements of ICF, orally stated, understood by participant 4 components of consent process for short form - ✔✔1. short form document
9. oral presentation of ICF elements
10. IRB approved summary
11. a witness When can you use short form? - ✔✔language, short window ICF monitoring - ✔✔1. most recent IRB approved version
12. signature present
13. subject dated/correct date
14. errors corrected by a single line
15. all pages present SAE Reporting Requirement - ✔✔immediately investigator, 15 days for sponsor UADE Reporting Requirement - ✔✔10 days investigator, 10 days for sponsor

Consent and Assent for children - ✔✔Parental consent from 1 or both parents or LAR required, and child assent may be required as determined by IRB Time period where financial disclosure is needed - ✔✔during the study and one year after completion The primary goal of the IRB - ✔✔to protect the right and safety of human subjects Composition of IRB - ✔✔5 or more members with different backgrounds including 1 scientific, 1 nonscientific, and 1 not affiliated Definition of minimal risk and its expedited review process - ✔✔no more harm than routine exam; individual reviewer Definition of significant risk and non-significant risk device - ✔✔SR: the potential for serious risk, support human life, substantial importance NSR: does not meet SR requirement Difference between SR and NSR device studies - ✔✔SR: Follows all IDE reg., IDE app approved NSR: abbreviated requirements, no IDE app, and sponsor/IRB no report to FDA prior Time required for IRB record retension - ✔✔3 years after study completion Two common tools used for reducing bias - ✔✔Blinding and Randomization Data Safety Monitoring Plan (DSMP) - ✔✔is used to ensure safety of subjects and validity of data

Data Safety Monitoring Board (DSMB) - ✔✔a group of experts that reviews research data 3 primary investigator responsibilties - ✔✔1. oversee the conduct of the trial

2. protect the rights, safety, and welfare of subjects
3. control the use of the investigational product Significance of FDA 1572 and investigator agreement (device) - ✔✔a declaration of the investigator to comply with FDA regulations Commitment of Investigator listed on 1572 - ✔✔1. follow the protocol
4. personally conduct or supervise the study
5. obtain informed consent
6. report AE
7. properly train staff
8. maintain records
9. ensure compliant IRB oversees
10. comply with all other CFR requirements FDA dateline for investigator reporting SAE(s) (drug) - ✔✔does not give specific, just immediately report to sponsor, and promptly to IRB

FDA dateline for investigator reporting SAE(s) (device) - ✔✔does give specific, within 10 working days after discovery Investigator Responsibilities for ICF - ✔✔- obtain legally effective informed consent

• provide sufficient opportunity to decide
• minimize coercion or undo influence
• language understandable to the subject
• avoid exculpatory (waive legal rights)
• current version of IRB approved ICF Show ICF obtained prior to study procedures - ✔✔to record the time of consent Definition of essential documents - ✔✔documents that permit evaluation of the conduct of a trial and the quality of the data produced Time required to keep clinical trial records at site - ✔✔2 years after FDA approval or 2 years after study ended Quality Control (QC) focuses on what? - ✔✔identification and correction Quality Assurance (QA) focuses on what? - ✔✔prevention Corrective And Preventive Actions (CAPA) process - ✔✔to identify root cause of issues or problems and actions to resolve them

CAPA plan - ✔✔a document that describes the CAPA process A sponsor is... - ✔✔an entity that initiates a clinical trial A sponsor does not conduct a clinical trial directly, but... - ✔✔through clinical site(s) Under the regulation who is responsible for the clinical trial conducted under its initiation and oversight? - ✔✔the sponsor Role, Responsibilities, and Obligations of the Sponsor - ✔✔- selecting qualified investigators

• providing information and training needed
• monitoring the trial conduct
• ensuring protocol is followed
• maintaining effective IND
• proper reporting of significant AE or risks What is a sponsor's main responsibility? - ✔✔overall clinical trial conduct is in compliance of regulations Sponsors should qualify investigators based on what? - ✔✔training and experience Info needed from investigator prior to trial participation - ✔✔- 1572
• CV

• Signed protocol
• FDF Sponsor must choose who to oversee the trial? - ✔✔a qualified monitor Other sponsor responsibilties - ✔✔- monitor the progress
• secure compliance or discontinue shipment of IP
• review safety and efficacy data and report safety issues to FDA
• submit annual reports to FDA
• discontinue use of IP that cause significant risk, notify FDA 5 working days, destroy IP, and submit full report to FDA of study closure How long does a sponsor have to submit IND safety report? - ✔✔within 15 calendar days after knowing How many days does sponsor have to submit additional information to FDA? - ✔✔within 15 calendar days after receiving request How long does sponsor have to notify FDA of unexpected fatal or life-threatening suspected adverse reaction? - ✔✔within 7 calendar days of initial receipt of info How long does the sponsor have to report unanticipated adverse device affects (UADE)? - ✔✔within 10 working days of receipt of the info

Items to be considered for an electronic record system - ✔✔- completeness, accuracy, reliability, consistency, and ability to detect invalid records

• SOP usage
• audit trail
• limited access
• back-up
• checking systems (operational, authority, device)
• qualified personnel
• accountability of misconduct/falsification
• authenticity, integrity, and confidentiality Record retention requirements for drug sponsor - ✔✔2 years after approval or 2 years after last shipment of IP and FDA notified Record retention for device sponsor - ✔✔2 years after study completion or 2 years after PMA date or date on notice of completion Phases of drug development - ✔✔- Discovery (screening of small molecules, natural products, extract)
• Pre-clinical (animal testing, PK, PD)
• Phase 0 (PK and PD in humans), Phase I (safety), Phase II (efficacy), Phase III (pivotal studies), Phase IV (post marketing surveillance) Medical Device Classification - ✔✔- Class I- general controls (bandages, gloves)

• Class II- general controls + special controls (x-ray machine, infusion pump) may require 510(K) clearance
• Class III- general controls + pre-market approval (HIV test, pacemaker) usually requires PMA Medical device trials do not have phases, but are usually done in what two steps? - ✔✔pilot and pivotal Regulatory pathways - ✔✔SR full NSR abbreviated exempt is exempt from IDE app IVD classification - ✔✔- Class I- general controls
• Class II- general controls + special controls, may require 510(K) clearance
• Class III- pre-market approval required Focus Areas during FDA inspection of Sponsor/CRO - ✔✔- personnel and organization
• site selection and communication w/ site
• monitoring and AE monitoring/reporting
• data handling/verification
• control of IP
• electronics systems
• record retention 3 possible classifications a sponsor/CRO after FDA inspection - ✔✔1. official action indicated

2. voluntary action indicated
3. no action indicated Focus areas during FDA inspection of site - ✔✔- personnel and organization

• facility
• IRB approval
• protocol adherance
• documentation of informed consent
• data collection
• IP accountability
• financial disclosure
• clinical trial oversight/ monitoring
• electronic data
• adverse evnts
• record retention