US Code of Federal Regulations Flashcards
HHS: Title 45 CFR Part 46
Policy for Protection of Human Research Subjects-Common Rule
Title 21 CFR Part 11
Electronic Records, Signature
Title 21 CFR Part 50
Informed Consent
Title 21 CFR Part 54
Financial Disclosure
Title 46 CFR Part 56
Institutional Review Boards
Title 21 CFR Part 312
Investigational New Drug Application
Title 21 CFR Part 812
Investigational Device Exemption
Public Health: Title 42 Part 11
Clinical Trials Registration and Results Submission
General requirements for informed consent
45 CFR 46.116 & 21 CFR 50.20
IRB Membership Requirements
45 CFR 46.107 & 21 CFR 56.107
IRB Functions and Operations
45 CFR 46.108 & 21 CFR 56.108
Criteria for IRB Approval of Research
45 CFR 46.111 & 21 CFR 56.111
Review by Institution
45 CFR 46.112 & 21 CFR 56.112
21 CFR Part 803
Medical Device Reporting
21 CFR Part 812
Investigational Device Exemption (counterpart to IND requirements 21 CFR 312
21 CFR Part 820
Quality Systems Regulations (counterpart to GMP requirements)
21 CFR 814
Premarket Approval of Medical Devices (counterpart to NDA requirements 21 CFR 314)
21 CFR Part 860
Medical Device Classification Procedures
42 CFR 11
ClinicalTrials.gov
*Applicable Clinical Trial ACT includes interventional studies (with one or more arms) of clinical trials including health-related outcomes, drug, biologic, or device products
21 CFR 312.60-312.70
Investigator’s Responsibilities
312 subpart D, 812 subpart E
Investigator’s responsibilities
21 CFR 312.64
Investigator’s responsibility to report adverse events during the study
21 CFR 312.62
Maintain adequate and accurate records
21 CFR 312.68
Make study records available for inspection
Financial Disclosure by Clinical Investigators
21 CFR 54
Financial Interest and Arrangements of Clinical Investigators (Form FDA 3454)
This is for clinical investigators who have no disclosable financial interest in or arrangements with the sponsor of the covered clinical study
Financial Interests and Arrangements of Clinical Investigators (Form FDA 3455)
The named individual has participated in financial arrangements or holds financial interests that are required to be disclosed as follows:
The form should include an attachment with detailed information about the financial interest and arrangements and a description of the steps taken to minimize the potential for bias.
21 CFR 56 & 45 CFR 46
Institutional Review Board
21 CFR 50; ICH E6, Sec. 4.8 and 45 CFR 46
Informed Consent
General Requirements for informed consent
21 CFR 50.20 & 45 CFR 46.116 and 45 CFR 46.117
Exception from general requirements
21 CFR 50.23
Exception from informed consent requirements for emergency research
21 CFR 50.25
Additional protections for pregnant women, human fetuses, and neonates involved in research
45 CFR 46 Subpart B
Elements of informed consent
21 CFR 50.25
Additional protections about biomedical and behavioral research involving prisoners as subjects
45 CFR 46 Subpart c
Documentation of informed consent
21 CFR 50.27
Additional protections for children involved as subjects in research
45 CFR 46 Subpart D
Additional safeguards for children in clinical investigations
21 CFR 50 Subpart D
Waiver of written consent
45 CFR 46.117(c) and 21 CFR 56.109(c)(1)
-The research involves no more than minimal risk to the subjects
-Linking research to the subject would present a potential farm
-IRB may require providing written information to the subject
45 CFR 46
Names vulnerable populations: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons
21 CFR 56
Names vulnerable populations: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons
What is the definition of “Child”
21 CFR 50.3 & 45 CFR 46.402
Persons who have not attained the legal age or consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted
Parental Permission
21 CFR 50.3 and 45 CFR 46.402
21 CFR 314
New Drug Application
Part 11
Electronic Records; Electronic Signature
Part 50
Protection of Human subjects
Part 56
Institutional Review Board
Part 312
Investigational New Drug Application
Part 812
Investigational Device Exemptions
21 CFR 11 Subpart A
Electronic records, electronic signature
Subpart A-General Provisions
§11.1 Scope.
§11.2 Implementation.
§11.3 Definitions.
21 CFR 11 Subpart B
Electronic records, electronic signature
§11.10 Controls for closed systems.
§11.30 Controls for open systems.
§11.50 Signature manifestations.
§11.70 Signature/record linking.
21 CFR 11 Subpart C
Electronic records, electronic signature
§11.100 General requirements.
§11.200 Electronic signature components and controls.
§11.300 Controls for identification codes/passwords.
21 CFR 50 Subpart A
Protection of Human Subjects
§50.1 Scope.
§50.3 Definitions.
21 CFR 50 Subpart B
Informed Consent of Human Subjects
§50.20 General requirements for informed consent.
§50.23 Exception from general requirements.
§50.24 Exception from informed consent requirements for emergency research.
§50.25 Elements of informed consent.
§50.27 Documentation of informed consent.
21 CFR 50 Subpart D
Additional Safeguards for Children in Clinical Investigations
§50.50 IRB duties.
§50.51 Clinical investigations not involving greater than minimal risk.
§50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual
subjects.
§50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely
to yield generalizable knowledge about the subjects’ disorder or condition.
§50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children.
§50.55 Requirements for permission by parents or guardians and for assent by children.
§50.56 Wards.
