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Nicki Kauffman
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Decks in this class (27)
Clinical Safety Data Management
An adverse event is defined as on...,
An adverse event is one which 2,
A subject in an arthritis clinica...
33
cards
General Considerations for Clinical Trials
The ethical principles underlying...,
The term non clinical studies ref...,
Nonclinical studies a should be p...
36
cards
Statistical Priniciples in Clinical Trials
The primary concern in a confirma...,
Statistical principles are releva...,
Bias is defined as a error in mis...
54
cards
Clinical Investigation of Pediactric Population
The decision to proceed with a pe...,
The decision to proceed with a pe...,
Formulation of pediatric drugs ma...
34
cards
ICH Good Clinical Priniciples Part 1
In ich gcp an audit is defined as 1,
In ich gcp an inspection is defin...,
In ich gcp monitoring is defined ...
35
cards
ICH Good Clinical Priniciples Part 2
According to ich the investigator...,
According to ich the sponsor may ...,
According to ich the investigator...
35
cards
ICH Good Clinical Priniciples Part 3
Regarding withdrawals or drop out...,
Ich guidelines for trial design i...,
Ich guidelines for protocol prepa...
30
cards
ICH Good Clinical Priniciples Part 4
Double blind study design entails...,
In a single blind trial the perso...,
The purpose of a double blind des...
30
cards
ICH Good Clinical Priniciples Part 5
With regard to liability claims t...,
The sponsor should ensure that in...,
With regard to access to medical ...
35
cards
IRB Records And Minutes
Irb minutes should record 1,
If a regular voting member and hi...,
The minutes of the irb meeting sh...
11
cards
IRB Membership and Voting
An irb member with a conflict of ...,
When reviewing studies involving ...,
The irb should a have a physician...
10
cards
IRB Decision Making
Actions that the irb can take whe...,
The decision to approve with cond...,
The irb may not approve a study i...
17
cards
Unanticipated Events
The most important consideration ...,
Timely and accurate reporting of ...,
A research subject enrolled in a ...
29
cards
Protocol Deviations
A protocol deviation is 1,
A pharmacist providing an investi...,
A subject in an ind protocol miss...
19
cards
DSMB (Data and Safety Monitoring Board
Regulations provide which of the ...,
An independent dsmb for a clinica...,
Dsmb s primary responsibility is ...
12
cards
Declaration of Helsinki
The declaration of helsinki was f...,
Which of the following ethical fr...,
The declaration of helsinki conta...
7
cards
Belmont Report
The principle of justice in the b...,
Respect for persons in the belmon...,
Which of the following is cited a...
10
cards
Investigational New Drug (IND)
A 1572 is a contract between 1,
According to fda regulations the ...,
Which of the following is not a c...
15
cards
Investigational Device Exemption (IDE)
A sponsor who makes a cardiac pac...,
A 510k premarket notification is ...,
An ide is required before a new d...
18
cards
Financial Disclosures
Financial disclosure in clinical ...,
With respect to financial disclos...,
Fda requires the disclosure by th...
11
cards
Clinical Trial Design And Implementation Part 1
The studies designed to first int...,
The studies with the highest risk...,
The studies with lowest number of...
30
cards
Clinical Trial Design And Implementation Part 2
In a two group parallel design tr...,
In an open label trial 2,
In a single blind trial 3
21
cards
Recruitment and Advertising
According to the fda guidance on ...,
According to the fda guidance on ...,
According to the fda guidance on ...
13
cards
Payments to Research Subjects
Payments to research subjects sho...,
According to fda guidance the pay...,
In a questionnaire study of homel...
11
cards
Withdrawal of Subjects
Withdrawal of subjects from a res...,
A subject withdrawing from a prim...,
If an investigator terminates a s...
9
cards
CRC Situational Analysis
The costs of a clinical trial are...,
During a monitoring visit the mon...,
For a subject who has had a conse...
43
cards
Elements of Informed Consent
An essential element of informed ...,
An essential element of consent t...,
The essential basic elements of c...
24
cards
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ACRP CCRC Exam Prep
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