100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
Previously searched by you
ACRP CCRC ACTUAL TEST 2024 WITH REAL QUESTIONS AND WELL VERIFIED ANSWERS || ALREADY GRADED + | GUARANTEED PASS | LATEST VERSION 2024/2025!!!$23.49
Add to cart
ACRP CCRC ACTUAL TEST 2024 WITH REAL QUESTIONS AND WELL VERIFIED ANSWERS || ALREADY GRADED + | GUARANTEED PASS | LATEST VERSION 2024/2025!!!
1 view 0 purchase
Course
ACRP CCRC ACTUAL
Institution
ACRP CCRC ACTUAL
ACRP CCRC ACTUAL TEST 2024 WITH REAL
QUESTIONS AND WELL VERIFIED ANSWERS ||
ALREADY GRADED + | GUARANTEED PASS |
LATEST VERSION 2024/2025!!!
Documents that may be inspected to show the sponsors oversight of trial may
include: - ANSWER-- Documents that describe transfer of obli...
ACRP CCRC ACTUAL TEST 2024 WITH REAL
QUESTIONS AND WELL VERIFIED ANSWERS ||
ALREADY GRADED + | GUARANTEED PASS |
LATEST VERSION 2024/2025!!!
Documents that may be inspected to show the sponsors oversight of trial may
include: - ANSWER-- Documents that describe transfer of obligations
- Investigator/site qualifications/selection process and training
- Monitoring plans, reports and corrective actions through the monitoring process
According to ICH E9, IDMCs should provide what? - ANSWER-- Intervals assess
the safety of clinical trial
- Recommend to sponsor whether to continue, modify, or stop trial
What does NAI stand for? - ANSWER-No action indicated
What does VAI stands for? - ANSWER-Voluntary action indicated
What does OAI stand for? - ANSWER-Official action indicated
A report prepared by marketing-authorization holder describing the worldwide
safety experience with medicine at defined time after authorization is called? -
ANSWER-Periodic Safety Update Report (PSUR)
,Potential reasons for an unannounced clinical investigator inspection can include
what? - ANSWER-- Receipt of complaint
- On termination of clinical site
- In response to sponsor or IRB/IEC inspections
Important immediate inspection preparation strategies include: - ANSWER--
Inform personnel
- Secure facility resources
- Organize study related documents
- Ensure access to original data
Directed/for-cause inspections may focus on? - ANSWER-The particular reason
that prompted the inspection
What is the major focus area for routine inspections for a clinical investigator? -
ANSWER-- Data reviews
- ICF process and documentation
What is the major focus area for a sponsor/CRO GCP inspection related to trial? -
ANSWER-- Vendor selection and management
- Data management (e.g. review of data management plan)
Common inspection management strategies include? - ANSWER-- Scope of
inspection
- Understand inspection timeframes
-Copy of personnel records
,What type of risk-based inspection involves the selection of a number of clinical
trials for the inspection sample? - ANSWER-Routine National Systems Inspections
True or False? Globalization of clinical research is a major factor that's led to
development of a common and accepted framework and sharing of inspection
observations in different regions. - ANSWER-True
The FRD CDER published information about inspection site selection tools that
takes into account what three levels of risk attributes? - ANSWER-Application
level, study level, clinical site level
Factors that influence GCP inspection selection process include? - ANSWER--
The number of UK patients and nature of subjects
- Outcome of previous GCP inspections
- Organization with no inspection history
True or False? Concerns about accuracy of submitted data can include an unusual
recruitment pattern. - ANSWER-True
True or False? For the EMA, inspections are conducted by the EMA inspectorate
of the EU. - ANSWER-False
True or False? Comprehensive data management plans can help ensure the
recording of accurate and complete data. - ANSWER-True
True or False? Regulatory investigators must have rights/privileges granted for
electronic record systems. - ANSWER-True
, Current coordinator is asked a question about the enrollment source completed by
prior coordinator during regulatory inspection. What should her response be if she
knows the correct answer? - ANSWER-Decline answer as she has no first-hand
knowledge of the creation of source document
Which are for full-analysis sample set? - ANSWER-- Includes all randomized
subjects
- Complete follow-up of all randomized subjects for study outcomes if necessary
- Most likely to mirror normal day to day practice
Which are for a per-protocol sample set? - ANSWER-- Completion of pre-
specified minimal exposure to treatment is necessary
- Availability of measurements of primary variable is necessary
- No major protocol violations nor violation of entry criteria
Investigator continues to randomize patient until patient is grouped with
investigators desired product. Is this ethical? - ANSWER-No
Data manager suspects fraud and immediately calls investigator stating fraud was
committed. Was this the best course of action? - ANSWER-No
What must or may the physician do with regard to unproven intervention?
(Declaration of Helsinki) - ANSWER-May consider an unproved intervention
What are expected or possible consequences of over-estimation of recruitment
potential? - ANSWER-- The trial will overrun its projected timeline
- The recruitment period will be prolonged and more sites may be needed
- The study will not have sufficient data within the required timeframe and will be
stopped because of lack of budget
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 winnieelizabeth424. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $23.49. You're not tied to anything after your purchase.