21 CFR Flashcards
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
21 CFR 312.3
Defines term investigator as individual who actually conducts a clinical investigation
-responsible leader of the team
21 CFR 812.3
Unanticipated adverse device effect (UADE)
-any serious adverse event associated with a device that was not previously identified or UAP that relates to the rights, safety, or welfare of subjects
21 CFR 50.25
Lists the basic elements of informed consent
21 CFR 50.27
Documentation of informed consent is required
21 CFR 50.27 (b)
Allow the use of a short form consent document
-also in 45 CFR 46.117 (b)
21 CFR 56.102 (I)
Definition of minimal risk
-probability and magnitude of harm or discomfort is not greater than those encountered ordinarily in daily life or during routine physical exams or tests
21 CFR 56.101
Maintain IRB compliance in term of its policies and standard practice with the requirements of all relevant regulatory agencies
21 CFR 56.107
Summarizes criteria for IRB membership
- 5+ members
- diversity
- knowledgeable persons
- both men and women
- at least 1 scientific
- at least 1 non scientific
- at least 1 not affiliated with institution
21 CFR 54.4 (b)
The regulation that requires investigators to provide information on financial interests and arrangements during the course of the study and 1 year after completion of the study
21 CFR 54.4 (a)
If there are financial interests involved, steps taken to minimize the potential for bias should be given to the FDA
21 CFR 54
Describes financial disclosure required by clinical investigators
21 CFR 56.108 (C)
Disapproval of a research can only be done with the non expedited review procedure
21 CFR 56.108 (a)
Requires IRB to follow written procedures
21 CFR 56.102 (g)
Defines IRB
-assure protection of human subjects (rights and welfare)
21 CFR 11.30
Describes regulations regarding electronic records and electronic signatures for an open system
-access not controlled
21 CFR 11.10
Describes regulations regarding electronic signatures and records for a closed system
-access is controlled by persons who oversee content
21 CFR 50.20
No person can participate in clinical research without the person or the person’s legally authorized representative (LAR)
-general requirements for informed consent
