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SOCRA CCRP Indispensable Study Assessment Guide Exam Questions with all Questions Accurately Answered Updated 2024/2025 CA$16.67   Add to cart
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SOCRA CCRP Indispensable Study Assessment Guide Exam Questions with all Questions Accurately Answered Updated 2024/2025
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SOCRA CCRP Indispensable Study Assessment Guide Exam Questions with all Questions Accurately Answered Updated 2024/2025 Quality Control (QC) focuses on what? - correct answer identification and correction Quality Assurance (QA) focuses on what? - correct answer prevention Corrective And Pr...

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  • November 5, 2024
  • 20
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • quality control qc
  • quality assurance qa
  • sponsor
  • fda
  • corrective and preventive actions capa
  • unanticipated adverse device affects uade
  • socra ccrp indispensable study assessment guide ex

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  • CCRP SOCRA
  • CCRP SOCRA

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KieranKent55

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SOCRA CCRP Indispensable Study
Assessment Guide Exam Questions with all
Questions Accurately Answered Updated
2024/2025

Quality Control (QC) focuses on what? - correct answer
identification and correction


Quality Assurance (QA) focuses on what? - correct answer
prevention


Corrective And Preventive Actions (CAPA) process - correct
answer to identify root cause of issues or problems and actions
to resolve them


CAPA plan - correct answer a document that describes the
CAPA process


A sponsor is... - correct answer an entity that initiates a clinical
trial


A sponsor does not conduct a clinical trial directly, but... -
correct answer through clinical site(s)


Under the regulation who is responsible for the clinical trial
conducted under its initiation and oversight? - correct answer
the sponsor

,Role, Responsibilities, and Obligations of the Sponsor - correct
answer - 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? - correct answer
overall clinical trial conduct is in compliance of regulations


Sponsors should qualify investigators based on what? - correct
answer training and experience


Info needed from investigator prior to trial participation -
correct answer - 1572
- CV
- Signed protocol
- FDF


Sponsor must choose who to oversee the trial? - correct answer
a qualified monitor


Other sponsor responsibilties - correct answer - 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? -
correct answer within 15 calendar days after knowing


How many days does sponsor have to submit additional
information to FDA? - correct answer within 15 calendar days
after receiving request


How long does sponsor have to notify FDA of unexpected fatal or
life-threatening suspected adverse reaction? - correct answer
within 7 calendar days of initial receipt of info


How long does the sponsor have to report unanticipated adverse
device affects (UADE)? - correct answer within 10 working days
of receipt of the info


Items to be considered for an electronic record system - correct
answer - 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

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