CRA
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- Created by: apelletier
- Created on: 08-11-18 20:58
1) What is the term for the study on what a drug does to the body?
Pharmacodynamics study
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The pharmaceutical industry is specialized in the discovery, development, production and marketing of:
Drugs and Medical devices for human subjects and animals
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What is an NDA?
An application to the FDA to approve a new drug for marketing
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Who is responsible for the safety and welfare of the subjects in clinical trial?
Everyone involved
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What is the most important consideration when conducting clinical research?
Protection of trial subjects
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A Clinical trial is
A study on humans to assess safety and efficacy of a new product
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What is the term for the study that defines the amount of the drug that stays in the human body over time?
Pharmacokinetics
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What does the letter D represent in "IND"?
Drug
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How is the characterization of a new compound to determinate its therapeutic potential performed?
With animals, cell and tissue culture, enzymes and computer models
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Who usually participates in Phase I clinical trials?
Less than 100 healthy voluntary subjects.
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When did ICH GCP become effective in Europe?
1998
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What is the regulatory authority governing medicinal products in the USA ?
FDA
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What does the 'E' mean in the ICH guidelines, e.g. ICH E6?
Efficacy
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What does Part E6 of ICH GCP discuss?
Good Clinical Practice
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What is the status of Canada in ICH?
Observer
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The Health Canada regulations on clinical trials are based on what?
ICH GCP and the FDA regulations with some additions
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How does FDA use the ICH GCP regulations?
As legally non-binding Guidelines
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What does MCA stand for?
Medicines Control Agency
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What does the letter "A" in FDA mean?
Administration
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What does the letter "A" in MedDRA mean?
Activities
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What does the R means in CFR?
Regulations
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What body finances the NIH studies?
DHHS
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What does FBC stand for?
Full Blood Count
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What is the Canadian law on clinical trials conduct?
FDA
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What does ADME mean?
Absorption, Distribution, Metabolism and Excretion
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What does CIOMS stand for?
Council for International Organisations of Medical Science
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What does MRI stand for?
Magnetic Resonance Imaging
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What are Phase II studies usually called
Dose determination study
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What is a Phase IV study usually called
Safety surveillance study
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What are the new Phase 0 studies usually called
Exploratory study
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How are drugs with serious side effects (like cancer drugs) tested?
On patients with the target disease
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For what phase do the terms for single and, multiple escalating doses SAD and MAD apply?
Phase I
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What are Phase III studies usually called
Confirmatory study
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Which studies are traditionally called FIH (First In Humans)?
Phase I studies
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When are drugs usually tested on women and children?
In the late phases
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What are Phase II studies usually called
Dose ranging study
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What documents may FDA review?
A and C only
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What is the definition of a CRO according to the FDA?
Legal entity, which assumes one or more obligations of sponsor
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Who has the ultimate responsibility for the investigational drug accountability at the study site?
The Principal Investigator
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What is FALSE about the FDA regulations?
Sponsor may develop his own rules
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What is the name of the regulatory permission to conduct a clinical trial in USA?
IND
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Which class are ultrasound diagnostic systems, if implants are class III ?
Class III (Moderate risk)
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What act authorizes Health Canada to regulate therapeutic products?
The Food and Drugs Act
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Which document allows selling a therapeutic product in Canada?
NOC (Notice Of Compliance)
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Where are the Canadian requirements for investigational Medical Devices found?
In the Canadian Medical Devices Regulations
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What body regulates the clinical research in Canada?
The Health Products and Food Branch (HPFB)
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When can a sponsor start a drug clinical trial in Canada?
After receipt of No Objection Letter
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When is the Abbreviated New Drug Submission (ANDS) used?
For generic products
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What document must the sponsor present to Health Canada to get an authorization for a clinical trial?
Clinical Trial Application (CTA)
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What does REC mean?
Research Ethics Committee
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How many members should be present at IRB meetings to have quorum under ICH?
It is not specified
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Who is responsible for the communication with the IRB/IEC?
The Principal investigator
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What do we call the member whose primary area of interests is not in the scientific area?
Lay member
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What are the usual timelines for a non-commercial Ethics Committee Approval ?
60 to 90 days
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To what should IRB/IEC pay special attention?
Vulnerable subjects
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What must the Investigator provide to IRB at the end of the study?
A summary of the trial outcome
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How long should the IRB/IEC retain documentation according ICH GCP?
3 years after the end of the clinical trial
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Who is responsible for the informed consent process?
The Principal investigator
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What should be the language used in the oral and written information about the trial, including in the written informed consent form according to ICH GCP?
Non-technical
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Who can sign a consent form on behalf of a subject according to ICH GCP?
Subject’s Legally Authorized Representative
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According to the Declaration of Helsinki, who can obtain consent ?
The investigator or another physician, designated by him
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If a subject is unable to read and his legally acceptable representative is also unable to read, then who should be present during the entire informed consent discussion?
An impartial witness
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When should the informed consent be taken by a physician not engaged in the investigation, according to the Declaration of Helsinki?
When subject is in a dependent relationship to the investigator or may consent under duress
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Who can obtain informed consent from study participants?
It should be a physician or a qualified person, to whom he delegated this responsibility
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What is the timeline for an Investigator to report a SAE to the Sponsor?
Immediately
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If all information for a complete report on a fatal SUSAR is not available within 7 days, what is the deadline for a follow-up report?
Another 8 days
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What is the difference between SAE and SUSAR (Suspected Unexpected Serious Adverse Reaction)?
A SUSAR is a SAE, which is unexpected and considered related to study drug
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What is the timeline for the Sponsor to report a life-threatening Suspected Unexpected Serious Adverse Reaction (SUSAR)?
7 days
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A clinical trial subject breaks his leg in a skiing accident and arrives at his regular visit walking in crutches - is it an SAE?
Yes, but only if he stayed in hospital overnight, or had serious permanent complications
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Who is responsible for the IND Safety Reports?
The Sponsor
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What is a surrogate endpoint?
A measurement, related to the outcome and used in place of another, which is more difficult to assess
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To show that a specific pharmacokinetic parameter was the same for a generic product as the original product, what sort of trial would you perform?
Equivalence
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If the expected withdrawal rate after randomisation is 20% and 200 patients are required to complete the clinical trial, how many patients will you need to randomise?
250
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What is the main purpose of blinding?
To reduce bias
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In a trial with three treatment groups of two active treatments and a placebo, subjects are allocated so that there will be twice as many subjects taking an active treatment than on placebo. What is the minimum block size possible with the allocation
6 subjects per group
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Who should the monitor inform immediately about ALL errors, omissions, discrepancies and protocol violations discovered during a site visit?
The Principal investigator
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How long should Sponsor-specific trial related essential document be retained?
2 years after marketing approval or trial discontinuation
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What information the investigator does NOT need to obtain from the IRB?
The IRB conditions for approval in case of changes in trial design
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Who provides insurance & indemnity to trial subjects in case of trial related injury ?
The Sponsor
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What is the FDA 1571 Form ?
IND application form
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When would be the best time for the Sponsor to ship the investigational product to an investigator?
During the Investigator meeting to use the momentum
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Who is responsible to assure the direct access of the CRA to the patient source documents acc. to ICH GCP?
The Investigator
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What is NOT required from Principal investigators in the Statement of Investigator Form 1572?
Current licence from a professional order
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Who is the person responsible to provide qualified advice on trial related medical issues not described in protocol and IB?
The Sponsor Medical Monitor
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Who provides insurance & indemnity to trial subjects in case of trial related injury?
The Sponsor
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The investigator may implement a deviation or a change of the protocol to eliminate an immediate hazard for the subjects without prior IRB/IEC approval or favorable opinion. What should be submitted as soon as possible to the IRB/IEC, the Sponsor and
A only
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Who prepares the data analysis plan for the protocol?
The Study Biostatistician
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With which of the following areas is associated to the international standard ISO-10993 as discussed in chapter 4?
Conducting clinical trials with medical devices
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When must an investigator implement a deviation from, or change to a protocol without agreement of the sponsor and prior approval/favourable opinion of the IRB/IEC?
To eliminate an immediate hazard to trial subjects
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Other cards in this set
Card 2
Front
The pharmaceutical industry is specialized in the discovery, development, production and marketing of:
Back
Drugs and Medical devices for human subjects and animals
Card 3
Front
What is an NDA?
Back
Card 4
Front
Who is responsible for the safety and welfare of the subjects in clinical trial?
Back
Card 5
Front
What is the most important consideration when conducting clinical research?
Back
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