Exam (elaborations)
ACRP CCRC Exam Prep Questions & Answers (Module Quiz)
ACRP CCRC Exam Prep Questions & Answers (Module Quiz)
[Show more]
Content preview
ACRP CCRC Exam Prep Questions &Answers (Module Quiz)
What are expected or possible consequences of over-estimation of
recruitment potential? - -- 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
-What should be the first consideration when conducting a clinical trial? - -
Subject welfare
-When is the investigator allowed to deviate from the protocol? - -When
there is an immediate hazard to a patient.
-If the investigator wanted to deviate from the protocol for an immediate
hazard to a patient, according to ICH E6 guidelines who world they need to
report the deviation and rationale to, if appropriate? - -- The Sponsor
- IRB/IEC
- Regulatory Authorities
-Which conditions should be fulfilled when enrolling a subject into your trial?
- -- Subject meets all inclusion criteria
- Subject has given written informed consent
-You've been delegated to handle the storage and inventory of IP. The study
drug must be stored below 25C/77F. On a summer Monday morning you
discover that the temperature recording machine in the storage room has
failed so you doin't know what the temperature has been over the weekend.
You check the current temperature; it's 24C/75F. What should you do? - --
Contact the Sponsor, explain what happened and ask for instructions
- Set up a site staff meeting to conduct a root cause analysis
-A protocol amendment was issued for a trial. Your site received IRB
approval for the amendment and wants to implement the increase in PO
dose for your trial subjects as identified in the amendment trial subjects. As
delegated consenting duties you must re-consent trial subjects before being
able to administer the adjusted dose. You decide to only re-consent trial
subjects who are still taking the IP and not from the subjects woh already
completed their drug intake period. Is this allowed according the E6
Guideline for GCP? - -No, these subjects are still enrolled in the trial and
therefore need to be updated on any changes to the protocol.
, -A trial subject informs you she no longer wants to participant in the trial.
What should your course of action be? - -You ask if the patient wishes to
share the reason why she wants to leave the trial. If not, you exclude the
subject from the trial immediately.
-A patient cannot recall the name of the heart condition medication he took
a few years ago. This is important information for deciding whether the
patient may be enrolled in a clinical trial (IC/EC). What's your best course of
action? - -You attempt to retrieve the patients medical history by contacting
previous caregivers and you wait for additional information before
enrollment.
-Who has ultimate trial responsibility for each subject? - -The principle
investigator.
-A trial subject suffers from severe repeat headaches. Should this adverse
event be reported to the IRB? - -No
-What statements are true concerning an adverse drug reaction? - -- All
noxious and unintended responses to a medicinal product related to any
dose should be considered as an ADR
- An ADR suggests a relationship to trail medication
- All ADRs must be documented
-What Adverse Events (AEs) are Serious Adverse Events (SAEs)? - -- Any AE
that results in death
- Any AE that results in inpatient hospitalization
- Any AE that is a congenital anomaly
-During a study visit a patient tells the investigator that she visited an
emergency room and received intensive treatment for allergic
bronchospasm. Since the patient was in the emergency room for only three
hours, the investigator did not assess the event as serious. Is this a correct
assessment? - -No, this would be a medically important event and should be
considered serious
-What data points minimally need to be reported by the site when reporting
an SAE, so that the sponsor can process the event? - -Identification of event,
product, and trial subject
-During a visit with investigator, a subject reported feeling heart palpitations
for a brief period of time during the previous evening. The heart palpitations
resolved without reoccurrence. The investigator considered these symptoms
to be unrelated to study drug. The next day, the subject told a fellow student
that he felt tired and was planning on taking a nap. Later, the subject was
found dead. A preliminary report from the medical examiner indicated the
, subject died of pulmonary embolism. What should your next course of action
be? - -- Record these events in case report form
- Immediately notify sponsor about serious adverse events
-When asked by a regulatory body why they received SAE related
information on 12/2013 from an incident that occurred in 5/2013, the
sponsor explained the reason being they received the trial related SAE
information from the investigator in 12/2013. Is the sponsor correct in only
holding the investigator accountable for their late reporting? - -No, the
sponsor should support the conduct QC activities with the sites to help them
ensure timely SAE reporting.
-A trial subject in a cardiology trial is admitted to hospital with heart attack.
The investigator considers this event possibly related to the study drug even
though this is not listed in the IB as a potential adverse reaction. What would
the investigator report this event to the sponsor as? - -An unexpected,
serious adverse event
-A 22y/o male was entered into a clinical study for treatment of
schizophrenia The study drug was administered orally, BID. One week later,
the subject visited the investigator complaining of sever sore throat. The IB
lists this as an occurrence reported by 1% of subjects receiving drug. How
should this severe throat be classified? - -- An adverse event
- An adverse drug reaction
-In regards to AE and ADR reporting, what statements are true? - -- All ADRs
are AEs but not all AEs are ADRs
- Worsening in pre-existing medical conditions is an AE
-Preplanned hospitalization is usually not an SAE
-What determines the causality of an adverse event? - -The investigator
-Which term best describes the cyclical process that involves the Plan, Do,
Check, Act activities? - -Quality improvement
-Which term best describes an independent assessment of completed work
to ensure it will meet applicable quality standards? - -Quality assurance
-Which term best describes the activities done to ensure quality output? - -
Quality control
-Which term requires structure and a definition of acceptable standards of
performance? - -Quality planning
-Which is represented in ALCOA-C? - -Attributable
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 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 Victorious23. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for £11.76. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
75759 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy revision notes and other study material for 14 years now