SOCRA CCRP Flashcards
1
Q
Double Dummy
A
A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be identical
2
Q
Meta-Analysis
A
The formal evaluation of the quantitive evidence from two or more trials bearing the same questions
3
Q
Study Director
A
Has the overall responsibility for the technical conduct of the study
4
Q
21 CFR 312
A
Deals with Investigational New Drug Application
5
Q
CFR
A
Code of Federal Regulations
6
Q
CRO
A
Contract Research Organization
7
Q
IDE
A
Investigational Device Exemption
8
Q
21 CFR 50
A
Protection of human subjects
9
Q
IRB
A
Institutional Review Board
10
Q
CFR
A
Case Report Form
11
Q
FDA
A
Food and Drug Administration
12
Q
ICH
A
International Conference for Harmonization
13
Q
CCRP
A
Certification for Clinical Research Professionals
14
Q
SOCRA
A
Society for Clinical Research Association
15
Q
IND
A
Investigational New Drug Application
16
Q
IEC
A
Independent Ethics Committee
17
Q
The Belmont Report
A
3 Principles:
- Benefice
- Respect for person
- Justice
18
Q
Investigator
A
An individual who actually conducts a clinical investigation
19
Q
Sponsor
A
A person who initiates and supports, by provision of financial or other resources, a nonclinical study
20
Q
Source Document
A
Original documents, data, and records
21
Q
Subpart D
A
Clinical investigations for children
22
Q
GCP
A
Good Clinical Practice
23
Q
Control Article
A
Purpose is establishing a basis for comparison with the test article
- Food additive
- Color additive
- Drug
24
Q
Clinical Investigation
A
Any experiment in which a drug is administered or dispensed to, or used involving one or more human subjects
25
Misbranding
Section 502 of Federal Food, Drug, and Cosmetic Act
26
Randomization and Blinding
Helps avoid possible bias in the selection of subjects arising from the predictability of treatment assignments
27
Randomization
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias
28
Blinding/Masking
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s)
29
Single-Blinding
Usually refers to the subject(s) being unaware
30
Double-Blinding
Usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s)
31
Audit Trail
Documentation that allows reconstruction of the course of events
32
Comparator (Product)
An investigational or marketed product (ie active control), or placebo, used as a reference in a clinical trial
33
Form 3455
Certification: Financial interest and arrangements of clinical investigators
34
Quality Assurance Unit
Any person or organization element, except the study director, designated by the testing facility management to perform the duties relating to quality assurance of nonclinical lab studies
35
FDA Form 1571
Coversheet for Investigational New Drug Application
36
Testing Facility
A person who actually conducts a nonclinical lab study
37
Monitor
An individual designated by a sponsor or contract research organization to oversee the progress of an investigation
38
Principal Investigator
The physician who leads the conduct of a clinical trial at a study site
39
Test Article
Any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360 F of the Public Health Service Act
40
Transitional Device
A device subject to Section 520(1) of the act, that is, a device that the FDA considered to be a new drug or an antibiotic drug before May 28, 1976
41
Assent
A child's affirmative agreement to participate in a clinical investigation
42
OHRP
Office of Human Research Protections
43
Phase 1
- Patients or normal volunteers
| - Range of 20 - 80 people
44
Phase 2
No more than several hundred subjects
45
Phase 3
- Controlled and uncontrolled trials
| - Several hundred to thousand subjects
46
Exempted Investigations
A device, other than a transitional device, in commercial distribution immediately before May 28, 1928, when used or investigated in accordance with the labeling indications in effect at that time
47
Individual Study Information
A brief summary of the status of each study in progress and each study completed in the previous year
48
CDER
Center for Drug Evaluation and Research
49
CBER
Center for Biologics Evaluation and Research
50
Significant Risk Device
Investigational device that is needed in treatment or care but also poses significant risk to the health of subjects
51
Meta-Analysis
The formal evaluation of the quantitive evidence from two or more trials bearing the same questions
52
Study Director
Has overall responsibility for the technical conduct of the study
53
21 CFR 312
Deals with Investigational New Drug Application
54
5 working days
The documentation required after using a test article shall be submitted to the IRB in how many days?
55
30 days
The FDA shall provide a written determination after the FDA receives the IND or earlier in how many days?
56
10 days
The sponsor's request for a regulatory hearing must be made within how many days of the sponsor's receipt of the FDA's notification of non-acceptance?
57
30 days
If the FDA proposes to terminate an IND, the FDA will notify the sponsor in writing, and invite correction or explanation within a period of how many days?
58
- 30 days after the FDA receives the IND
| - On earlier FDA authorization to ship the drug
When may the sponsor ship an investigational new drug to the investigators name in the IND?
59
30 days
As soon as possible, and no more than how many days after the imposition of the clinical hold, the Division Director will provide the sponsor with a written explanation on the basis for the hold?
60
7 calendar days
The sponsor shall notify the FDA by telephone or fax of any unexpected fatal or life-threatning experience associated with the use of the drug as soon as possible but no later than how many days after the sponsor's initial receipt of the information?
61
30 days
An IND goes into effect how many days after the FDA receives the IND, unless the FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold?
62
60 days
A sponsor shall have how many days of the anniversary date that the IND went into effect to submit a brief report of the investigation's progress?
63
2 years
If a study is submitted in support of an application for marketing approval, records must be kept for how many years after an agency decision on that applications?
64
2 years
If the study is submitted in support of an IND but not an application for marketing approval, the records must be kept for how many years after the submission of the IND?
65
1 year
The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for how many years following the study's completion?
66
Contract Research Organization (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions
67
Life-threatening
An adverse event or suspected adverse reaction is considered “life-threatening” if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death
68
Serious Adverse Event
An adverse event or suspected adverse reaction is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect
69
Investigational new drug
New drug or new biological drug that is used in a clinical investigation
