CCRP Final Exam Study Guide [socra] *Q&A* |Verified Study Set| 2024/2025
4 views 0 purchase
Course
SOCRA
Institution
SOCRA
CCRP Final Exam Study Guide [socra]
*Q&A* |Verified Study Set| 2024/2025
What is the main function of Good Clinical Practice (GCP) guidelines?
To ensure the safety, integrity, and quality of clinical trial data.
What document must be submitted to an IRB before initiating a clinical trial?
...
CCRP Final Exam Study Guide [socra]
*Q&A* |Verified Study Set| 2024/2025
What is the main function of Good Clinical Practice (GCP) guidelines?
To ensure the safety, integrity, and quality of clinical trial data.
What document must be submitted to an IRB before initiating a clinical trial?
The study protocol and informed consent documents.
How does informed consent support ethical research practices?
It ensures participants understand the risks and benefits before agreeing to participate.
What is the primary goal of a Phase III clinical trial?
To confirm the effectiveness and monitor the adverse effects of a treatment in a larger
population.
What type of study design allows researchers to compare outcomes between groups receiving
different treatments?
A comparative study design.
In clinical trials, what does the term "enrollment" refer to?
The process of recruiting and registering participants into the study.
1
,What does it mean if a study is "double-blinded"?
Both participants and researchers are unaware of which treatment each participant is
receiving.
What are the responsibilities of a principal investigator (PI) in a clinical trial?
To oversee the trial's execution and ensure compliance with regulatory requirements.
What must be done if a participant experiences a severe adverse event?
It must be reported to the IRB and sponsor immediately, following specific guidelines.
What is the purpose of the clinical trial registry?
To enhance transparency and allow public access to information about clinical trials.
What type of data is typically collected through electronic data capture (EDC) systems?
Clinical and operational data related to trial participants and study outcomes.
What does "retrospective study" refer to in clinical research?
A study that analyzes data from past events or outcomes rather than collecting new data.
What is the role of a research monitor?
To ensure compliance with the protocol, regulations, and GCP throughout the study.
2
,How often should monitoring visits be conducted during a clinical trial?
Monitoring frequency is determined by the study’s complexity and risk level but typically
occurs regularly.
What is the definition of a "control group" in a clinical trial?
A group of participants that does not receive the experimental treatment and is used for
comparison.
What is a common reason for terminating a clinical trial early?
Safety concerns or finding that the treatment is ineffective.
What should be included in the informed consent document?
Information about the study's purpose, procedures, risks, benefits, and participant rights.
What does the term "subject recruitment" refer to in clinical trials?
The process of attracting and enrolling eligible participants to take part in the study.
What is the main objective of post-marketing surveillance?
To monitor the safety and effectiveness of a drug after it has been approved for public use.
What is the purpose of an adverse event reporting system in clinical research?
3
, To document and analyze any negative occurrences experienced by participants during the
trial.
What does the term "ethics approval" indicate?
That a research proposal has been reviewed and deemed ethically acceptable by an IRB.
How should data integrity be maintained in clinical trials?
By ensuring accurate and complete data collection, documentation, and reporting.
What is the difference between qualitative and quantitative research methods?
Qualitative research focuses on understanding phenomena, while quantitative research
emphasizes numerical data and statistical analysis.
What does the term "intent-to-treat analysis" mean in clinical trials?
An analysis that includes all randomized participants, regardless of whether they completed
the study.
What is the role of patient advocacy groups in clinical research?
To represent patient interests and perspectives, ensuring that research is aligned with their
needs.
What does "sample size determination" involve in study design?
4
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller StellarGrades. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.26. You're not tied to anything after your purchase.
