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