Exam (elaborations)
SOCRA CERTIFICATION EXAM 2024/2025 WITH 100% ACCURATE SOLUTIONS
- Course
- Institution
SOCRA CERTIFICATION EXAM 2024/2025 WITH 100% ACCURATE SOLUTIONS
[Show more]
Content preview
SOCRA CERTIFICATION EXAM 2024/2025 WITH 100% ACCURATESOLUTIONS
Jeff Washington works for the Acme Device Company, the sponsor of a new clinical trial named CLEAR2.
He has just been appointed as Clinical Trial Manager for the CLEAR2 study.
Which of the following best describes Jeff’s role in the CLEAR2 study?
A. Jeff guides clinical aspects of the trial.
B. Jeff oversees the operational execution of the trial.
C. Jeff focuses his time onsite at particular study sites, ensuring data is captured correctly.-
==Correct Answer: Jeff guides clinical aspects of the trial.-==
Jeff guides clinical aspects of the trial. The Clinical Trial Manager (also referred to as Clinical Scientist)
serves as the clinical lead on a study. While the Clinical Trial Manager may or may not be a physician,
this person usually has significant medical and research experience and guides clinical aspects of the
trial. The Clinical Trial Manager is also typically responsible for the entire development program for the
product, not just an individual trial.
Typically, the Project Manager, not the Clinical Trial Manager, oversees the operational execution of the
trial.
The Clinical Research Associate (CRA), not the Clinical Trial Manager, conducts onsite monitoring visits,
and during these visits one of their responsibilities is to ensure data are captured correctly.
You are the Clinical Research Coordinator (CRC) at a study site. You receive a batch of lab results from
the central lab for the study and note that one subject’s date of birth does not appear to match the date
of birth on the medical record for that subject at your site.
Whom should you contact at the central lab to rectify this discrepancy?
, A. The Help Desk
B. The Medical Director
C. The Project Manager-==Correct Answer: The Help Desk-==You would most likely contact the
Help Desk at the central lab first, to rectify this administrative discrepancy. Most central labs have a help
desk that is responsible for answering questions, solving lab issues and resupplying lab materials. Refer
to the Lab Manual provided by the central lab for your trial to find specific contact information.
The Project Manager is responsible for ensuring that the study progresses from the central lab
standpoint. The Medical Director has the responsibility of overseeing the entire central lab. These staff
members would not likely be responsible for administrative issues and would generally delegate tasks
such as verifying a date of birth to the help desk.
Both Sponsors and Contract Research Organizations/Academic Research organizations (CRO/AROs)
employ Project Managers (PMs), Medical Monitors, and Clinical Research Associates (CRAs) to conduct
clinical trials.
How do the roles of these individuals at the Sponsor differ from those at the CRO/ARO?
A. The individuals at the Sponsor organization generally have a less significant role in the study
than at the CRO/ARO.
B. All of these individuals have the same role at the Sponsor as they do at the CRO/ARO.
C. The individuals at the Sponsor generally have a more significant role on the study than at the
CRO/ARO.-==Correct Answer: All of these individuals have the same role at the Sponsor as they do at
the CRO/ARO.-==All of these individuals have the same role at the Sponsor as they do at the CRO/ARO;
it is just a matter of whether the Sponsor chooses to contract out these functions to a CRO/ARO or to
perform these functions themselves.
A drug’s safety is determined by which of the following criteria?
A. The dose at which no side effects are reported
B. The absence of harmful side effects on the individuals exposed to it so far
C. The Food and Drug Administration’s (FDA) review of source documentation at a clinical site-
==Correct Answer: The absence of harmful side effects on the individuals exposed to it so far-==The
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 YANCHY. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $16.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
80461 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now