21 CFR Flashcards
(41 cards)
21 CFR 56.109 (f)
Conducting continuing review of research at least once per year
21 CFR 56.109 (c)
Determine when and at what level of informed consent is required or waived
21 CFR 50.24
Exception from informed consent requirements for emergency research
21 CFR 812.110 (c)
Requires that an investigator administer the investigational product or supervise appropriate staff who will be administering for medical devise trials
21 CFR 56.115 (c)
FDA may refuse to consider a clinical investigation if the institution or IRB that reviewed the investigation refuses to allow an inspection
21 CFR 56.115 (b)
Requires that IRB records be reviewed for at least 3 years after completion of the research
21 CFR 56.113
Terminate any research that is not being conducted following regulations or research that caused unexpected serious harm to subjects
21 CFR 56.111 (a)
Requires criteria that an IRB must find when approving a study
- minimal risk
- documented consent
- selection of subjects is equitable
- monitor data
- privacy detected
- protect women, prisoners, children
21 CFR 312.32
Requires that the sponsor then must notify FDA and all participating investigations of potential serious risks ASAP or no later than 15 calendar days
21 CFR 312.60
Describes responsibilities of investigators
- oversee conduct of the trial under appropriate regulation
- protect the rights, safety and welfare of subjects
- control the use of investigational product
21 CFR 56.109
Describes an approach for IRB review of research
-continuing review and re-approval of a research study
21 CFR 56.109 (a)
Review, approve, or disapprove all research activities under its jurisdiction based on benefits and risks evaluation
21 CFR 56.109 (b)
Oversee informed consent process and all documents to be used and presented to subjects
21 CFR 56.115
Requires IRB to prepare and maintain documentation of IRB activities
- copies of all research proposals
- minutes of IRB meeting
- records of continuing review
- copies of all correspondences
- list of IRB members
- written procedures
21 CFR 809.3 (a)
Defines IVDs in vitro diagnostics away to test for certain property or result outside of the human body. EX. Testing blood, urine, glucose
21 CFR 312.62 (c)
Describes record retention for an investigator
- 2 years after FDA approval or
- 2 years after study ended
21 CFR 312.69
Controlled substance act requires that investigational product be kept in secure location with control access
21 CFR 312.64
Requires that an investigator immediately reports to the sponsor any SAE
- whether or not drug related
- include assessment of reasonable possibility that drug caused event
21 CFR 312.61
Describes the responsibilities of an investigator for investigational product use and access in drug trials
21 CFR 312.62 (a)
Requires investigators to maintain adequate records of disposition of the drug including dates, quantity and use by subjects.
-shall return unused supplies to the sponsor or provide disposition of unused supplies
21 CFR 312.52 (c) (3)
Lists items a clinical protocol should contain
-phase 1 general outline of the planned investigation estimated duration and # of control, kind of clinical observations, lab tests performed and copies descriptions of CRFs
21 CFR 812.150
Requires an investigator submits to sponsor and IRB a report of any UADE ASAP but no later than 10 working days after learning effect
- sponsor report to FDA and IRB within 10 working days
21 CFR 812.3(m)
Defines significant risk (SR) device as a investigational device that is
- intended as a implant represented to be of use for supporting or sustaining human life
- used for diagnosing, curing, mitigating, or treating disease
- otherwise prevents risk
21 CFR 812.2(c)
Defines an IDE exempt study
