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
2024 Newest |ACRP CCRC| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE $12.49   Add to cart
Quickly navigate to
Preview
  2.  
  3. Prep Tests
  4.  
  5. Prep Tests

Exam (elaborations)

2024 Newest |ACRP CCRC| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE
 0 view  0 purchase
  • Course
  • Prep Tests
  • Institution
  • Prep Tests

2024 Newest |ACRP CCRC| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE ADR - ANSWER-Adverse Drug Reaction Audit - ANSWER-Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certific...

[Show more]

Preview 4 out of 48  pages

Document information

  • November 11, 2024
  • 48
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • 2024 newest acrp ccrc updatecomprehens

Written for

  • Prep Tests
  • Prep Tests

Seller

avatar-seller
EmilyCharlene

Reviews received

Content preview

2024 Newest |ACRP CCRC|2024-2025 UPDATE|COMPREHENSIVE
FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED
ANSWERS|GET IT 100% ACCURATE



ADR - ANSWER✔✔-Adverse Drug Reaction


Audit - ANSWER✔✔-Reviews how the research was conducted; takes into account

SOPs, IRB requirements & GCP (ensures compliance)


Audit Certificate - ANSWER✔✔-Confirmation audit took place


Audit Report - ANSWER✔✔-Written Evaluation - not regularly made available to

regulatory body; only when serious evidence exists concerning non-compliance


Audit Trail - ANSWER✔✔-Documentation of audit events


Single Blind Study - ANSWER✔✔-Subjects Unaware


Double Blind Study - ANSWER✔✔-Subjects & Researchers are unaware


Comparator - ANSWER✔✔-Item used as an active control references in a clinical trail


Coordinating Committee - ANSWER✔✔-Group a sponsor comprises to coordinate

multi-center trials


Coordinating Investigator - ANSWER✔✔-An investigator who oversees multiple sites

of a clinical trial (multicenter)

Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 1/48

,IDMC - ANSWER✔✔-Independent Data Monitoring Committee, Data & Safety

Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety & progress;

make recommendations to continue, modify or stop


IEC - ANSWER✔✔-Independent Ethics Committee; group who oversees protection,

rights, safety & well-being of human subjects


Investigator's Brochure - ANSWER✔✔-Compilation of data on an investigational

product used in human subjects


Legally acceptable representative - ANSWER✔✔-person whom is lawfully able to

consent on behalf of another


SAE - ANSWER✔✔-Serious Adverse Event - Results in death, is life-threatening,

requires long-term hospitalization, results in long term disability/hospitalization

incapacitation or is a congenital birth defect


Source data - ANSWER✔✔-original clinical information from source documents

(medical record information)


Vulnerable subjects - ANSWER✔✔-*Hierarchical structure employees


*armed forces


*detainees


*incurable disease pts


Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 2/48

,*homeless


*poor


*those in nursing home


*minors


*those unable to give consent


ICH - ANSWER✔✔-International Conference on Harmonization


Principles of ICH & GCP - ANSWER✔✔-*Protect research subjects


*conduct research as it has been approved


*research should be clear, organized & approved by an IRB/IEC


IRB / IEC Responsibilities - ANSWER✔✔-*Oversee principles of ICH/GCP


*Make sure the PI / Co-Is are qualified


* Review studies at least once a year


Requirements of an IRB - ANSWER✔✔-* at least 5 members


* one non-scientific member


* one non-institute member


What needs reported to the IRB? - ANSWER✔✔-*Changes / deviations from protocol

due to unforeseen hazard

Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 3/48

, * changes to subject risk


* adverse events


* new info that may impact subject safety


Payment to subjects must be.... - ANSWER✔✔-prorated & not contingent on subject

completing study


Investigator Responsibilities - ANSWER✔✔-*Maintain delegation long


*Ensure staff are trained/informed about the protocol (give delegated tasks)


* Ascertain reason study participant withdraws consent while respecting their privacy

& rights


* Adhere to approved protocol


*Document & explain any deviations from approved protocol


* Process protocol amendments according to GCP


*Manage proper storage & care for trial devices/drugs. (PI can delegate this task to

trained professional - PharmD, etc)


Protocol amendments should be submitted to - ANSWER✔✔-1. IRB


2. Sponsor


3. Regulatory Authority



Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 4/48

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 EmilyCharlene. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $12.49. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

80467 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling

Recently viewed by you

Package deal ·

(0)

Hét perfecte pakket om je examen van Biologische Psychologie I Inleiding te knallen! (19/20 behaald)
$12.49
  • (0)
  Add to cart