100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Previously searched by you
Previously searched by you
logo
SOCRA CCRP Practice Study Guide Questions with Distinction level Marking scheme version 2024/2025 $11.49
Add to cart
Quickly navigate to
Preview
  2.  
  3. CCRP SOCRA
  4.  
  5. CCRP SOCRA

Exam (elaborations)

SOCRA CCRP Practice Study Guide Questions with Distinction level Marking scheme version 2024/2025
 0 purchase
  • 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...

[Show more]

Preview 3 out of 19  pages

Document information

  • November 5, 2024
  • 19
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

Written for

  • CCRP SOCRA
  • CCRP SOCRA

Seller

avatar-seller
KieranKent55

Reviews received

Content preview

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.

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

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

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

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 KieranKent55. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $11.49. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

67479 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 15 years now

Start selling
$11.49
  • (0)
Add to cart
Added