SOCRA CCRP Practice Study Guide Questions with Distinction level Marking scheme version 2024/2025
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Course
CCRP SOCRA
Institution
CCRP SOCRA
SOCRA CCRP Practice Study Guide Questions with Distinction level Marking scheme version 2024/2025
What is a CAPA?? - correct answer Corrective and Preventative Action. It is a process to identify root cause of issues or problems and actions to resolve them.. CAPA plan is a document that describe...
SOCRA CCRP Practice Study Guide Questions
with Distinction level Marking scheme
version 2024/2025
What is a CAPA?? - correct answer Corrective and Preventative
Action. It is a process to identify root cause of issues or problems
and actions to resolve them.. CAPA plan is a document that
describes the CAPA process.
What is quality assurance? - correct answer Planned and
systematic activities necessary to ensure that the trial is
performed and the data are generated and in compliance with
GCP and other regs.
What is quality control? - correct answer operational techniques
and activities to verify that the requirements for quality of the
trial-related activities have been fulfilled.
Difference between QA and QC - correct answer QC focuses on
identification and correction vs QA focuses on prevention
How is a Sponsor defined by FDA? - correct answer An entity
that initiates a clinical trial. Sponsor is not usually conducting
the trial directly, but through clinical sites. The sponsor is the
responsible party for the clinical trial conducted under its
initiation and oversight.
What is the Sponsor's main responsibility? - correct answer To
ensure that overall clinical trial conduct is in compliance with
regulations, which can be done by selecting qualified
,investigators, providing information and training, and monitoring
the trial conduct, and properly reporting significant AEs or risks.
What information is needed from Investigator prior to clinical
trial participation? - correct answer 1.investigator name and
address
2. protocol name/number
3. name and address of facilities
4. name and address of local lab
5. name and address of the IRB
6. Comment from the investigator (Investigator
Agreement/Statement 1572)
7. PI CV
8. clinical protocol
9. FDF
How should investigators be qualified for research participation?
- correct answer Via Training and Experience:
by reviewing Investigator statement form ( 1572), CV, signed
protocol, and FDF
What is recommended to be included within the Investigator
Brochure according to 21 CFR 312? - correct answer Includes:
1. description of the drug/device and the formulation (if known)
2. pharmacological and toxicological effects
3. pharmacokinetics and biological disposition in animals, and
humans, if known.
4. Safety and effectiveness in humans
, 5. possible risks and side effects
Monitoring Importants - correct answer 1. Sponsor must choose
qualified monitor (based on training and experience)
2. Sponsor must:
monitor the progress of the trial
3. secure compliance or discontinue shipment of IP to non-
complying investigator
3. Review safety and effectiveness data and report any safety
issues to FDA
4. Submit annual reports to FDA
5. Discontinue use of IP that causes unreasonable and significant
risk to subjects, notify FDA within 5 working days, and IRB,
destroy the IP, and submit full report to FDA of the study closure
For unanticipated adverse device effects, within how many days
does It need to be reported to FDA/IRB? - correct answer
Within 10 working days.
When is the annual report due for a drug trial due by the
Sponsor? - correct answer Within 60 days of the anniversary of
when the IND went into effect
What are the contents of the annual report for an IND study? -
correct answer Individual study info (summary status of
demographics), summary information such as from clinical and
nonclinical investigations - deaths, SAEs, understandings of the
drug/device action's, any significant changes that were required.
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