regulations, forms, definitions Flashcards
21 CFR 11
electronic signatures, electronic records
21 CFR 50
informed consent of human subjects
21 CFR 50.25
elements of informed consent
21 CFR 50.20
general requirements for informed consent
21 CFR 50.23
exception from general requirements of informed consent
21 CFR 50.24
exception from informed consent requirements for emergency research
21 CFR 50.27
documentation of informed consent
21 CFR 50 subpart D
additional safeguards for children in clinical investigations
21 CFR 50.51
clinical investigations NOT involving greater than minimal risk for children
21 CFR 50.52
clinical investigations INVOLVING greater than minimal risk but presenting prospect of direct benefit to subjects - children
21 CFR 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 disorder or condition - children
21 CFR 50.54
clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting health/welfare of children
21 CFR 50.55
requirements for permission by parents or guardians and for assent by children
21 CFR 50.56
wards
21 CFR 54
financial disclosure of investigators
21 CFR 56
IRBs
21 CFR 56.106-7
IRB membership
21 CFR 56.108-9
IRB functions and operations
21 CFR 56.110
expedited review procedures for research involving NO MORE than minimal risk for minor changes in approved research
21 CFR 312
procedures and requirements governing the use of investigational new drugs (including IND applications)
45 CFR 46
protection of human subjects (HHS)
45 CFR 46 subpart A
basic HHS policy for protection of human subjects
45 CFR 46 subpart B
additional protections for pregnant women, human fetuses, and neonates
45 CFR 46 subpart C
additional protections pertaining to biomedical and behavioral research involving prisoners as subjects
45 CFR 46 subpart D
additional protections for children and wards
CBER
center for biologics evaluation and research (center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act)
3454
certification of financial interests
3455
financial disclosure form (55=FF)
IDE
investigational device exemption (allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data)
483
inspections observations
482
notice of inspections
3500A
mandatory reporting of adverse events/problems (A= mAndAtory) (medwatch)
3500
voluntary reporting of adverse events/problems (medwatch)
