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coordinating clinical research practice exam

Terms in this set (50)

What is the purpose of an IRB?
To protect the rights and welfare of human subjects of research
When must the investigator obtain IRB approval of the study and the consent form?
Before enrolling any patients in the study
The IRB must inform the investigator the study has been approved by:
Written notification saying it has been approved
For initial approval of proposed research, the investigator must submit to the IRB:
The full protocol and the informed consent
Any proposed advertising for the study:
Must be submitted to the IRB and approved before it can be used
Any amendment that ____________ must be approved by the IRB prior to implementation.
a. Increases the risk to subjects
b. Decreases the number of subjects
c. Changes the protocol in anyway
d. All of the above
e. None of the above
a. Increases the risk to subjects
Which of the following are necessary to waive consent?
a. Subject is unable to give consent
b. No time or unable to contact next of kin
c. Life-threatening condition
d. No other treatment available
e. None of the above
f. All of the above
f. All of the above
The investigator's signature must be on the consent form. True or false?
False
The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as:
Informed consent
Informed consent is documented by:
A written, signed, and dated informed consent form
Which signatures are required by regulation to be on the consent form?
a. The investigator
b. The subject
c. The investigator and the subject
d. The subject and a witness
e. The investigator, the subject, and a witness
b. The subject
ICH guidelines provide a unified standard for __________ clinical trials involving human subjects.
Designing, conducting, recording, and reporting
What are the two main themes covered by the formal ICH definition of "Good Clinical Practice?"
The rights and well-being of study subjects, and credibility of the data
GCPs are derived from all of the following except:
a. Safety surveillance systems
b. Federal regulations
c. Ethical codes
d. ICH guidelines
e. Official guidance documents
a. Safety surveillance systems
Non-clinical studies refer to studies that do not involve:
a. Animal testing
b. Drugs
c. Human subjects
d. Toxicology parameters
e. Safety
c. Human subjects
In which development phase might normal, healthy volunteers be given a new drug?
Phase I
Large multi center studies are usually done in which phase?
Phase III
One of the primary purposes of a Phase II study is to:
Demonstrate efficacy within the established safe dose range
By regulation, an investigator must keep records relating to:
Disposition of the study drug, case histories, case report forms, and signed informed consent forms
Most Sponsors will expect an investigative site to keep all study records for:
Until the Sponsor says they may be destroyed
Which of the following should be kept separately from other study documents?
a. Signed consent forms
b. Grant information
c. IND safety reports
d. IRB communications
e. Screening logs
b. Grant information
A source document is any document where:
a. Lab values are shown
b. HIPAA authorization was received
c. Data are first recorded
d. A subject's name is shown
e. Sponsor access to the document is not allowed
c. Data are first recorded
Standard operating procedures (SOPs) are essential for:
a. Standardizing processes
b. Ensuring that regulatory requirements are met
c. Training new personnel
d. Managing workload
e. All of the above
e. All of the above
SOPs are:
Written descriptions of how tasks are to be performed
Once an SOP is in place, it should never be changed. True or false?
False
In general, a Sponsor will not place a study at a site without:
a. An on-site IRB
b. A study coordinator
c. An assurance that the study will enroll at least a given number of subjects
d. An assurance that there will be no staff turnover during the study
e. At least one sub-investigator who is a physician
b. A study coordinator
A competing study can be one that is ongoing in:
a. The site
b. The same clinic or hospital
c. The community
d. Only a and b above
e. a, b, and c above
e. a, b, and c above
Some of the questions an investigator and a CRC should ask when assessing protocol feasibility at their site include all the following EXCEPT:
a. Will the Sponsor pay at least 30% of the grant in advance?
b. Have we worked with this Sponsor before and was the partnership successful?
c. Is the number of subjects to be enrolled realistic?
d. Is the study scientifically sound?
e. Is the IRB apt to have problems with any aspects of this protocol?
a. Will the Sponsor pay at least 30% of the grant in advance?
Most Sponsors operate on which kind of basis when it comes to grant payments?
Fee-for-service
Financial disclosure applies to:
Only those people listed on the 1572
Investigator meetings are a requirement for any multi center study with six or more sites. True or false?
False
Study initiation meetings are usually held:
After the site has received all study materials and is ready to start enrollment
One of the most difficult aspects of doing clinical trials is:
Recruiting sufficient subjects
The FDA considers advertising for study subjects to be:
Part of the consent process
Payments to subjects in clinical trials should:
Be done only with prior IRB approval
Patient compliance with study drug dosing is a statistical issue, so site personnel do not have to be concerned about it. True or false?
False
Which of the following should NOT be included in the protocol?
a. A description of the objectives and purpose of the study
b. The inclusion and exclusion criteria for study subject
c. The design of the study
d. The amount of the grant per subject
e. The investigator's responsibilities
d. The amount of the grant per subject
Case report forms are usually completed by:
The CRC
In general, corrections to case report forms should be made by:
c. The CRC or the investigator
It is a regulatory requirement to have a source document for every data item collected on case report forms. True or false?
False
The most common reason for a study to be closed at a site is:
The study is complete
By regulation, investigators are required to make a final study report to:
a. The FDA and the Sponsor
b. The Sponsor and the IRB
c. The institution
d. The Sponsor, the IRB, and the FDA
e. The Sponsor
b. The Sponsor and the IRB
There are two main reasons that a Sponsor might audit a study site. They are:
To ensure that the site is complying with the regulations and protocol; or there is evidence that the site is out of compliance and the Sponsor wants to verify whether or not it is true.
The FDA __________ sponsor audit reports of a study site.
Does not have routine access to
In study-related audits by the FDA, the studies audited are usually:
Closed
The two main aspects of a study that will be looked at by the FDA during an audit are:
Study conduct and study data
There are three classifications that result from an FDA audit. The one that means that deviations from the regulations were found but that they were not serious, is:
VAI (Voluntary Action Indicated)
Define Investigator Brochure (IB). Page 178
A compilation of all information known to date about the test product, including chemistry and formulation information and preclinical and clinical data. It is updated at least annually. Once the product is marketed, it is replaced by the labeling (package insert) for the product.
What are the three classes of Establishment Inspection Reports (EIR) that result from an inspection? Page 169
NAI (No action indicated) - this is the best outcome, and means that no significant deviations from the regulations were found.
VAI (Voluntary action indicated) - This report will provide information about findings of deviations from the regulations and good clinical practice; may or may not require a response from the investigator.
OAI (Official action indicated) - this is the worst result to receive. This report identifies serious deviations and requires prompt action from the investigator.
List seven examples of a vulnerable population.
1. Children
2. Pregnant women
3. Prisoners
4. Handicapped or mentally disabled people
5. People with acute or severe mental illness
6. People who are economically or educationally disadvantaged
7. Those who are institutionalized
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