Socra Practice- 21Cfr Parts 11, 50, 54, 56, 312 & 812 Subparts & 45Cfr Part 46 Subparts

Front 1

What is 21 CFR Part 11 and what are it's Subparts?

Back 1

Electronic Records; Electronic Signatures

A. General Provisions

B. Electronic Records

C. Electronic Signatures

Front 2

What is 21 CFR Part 50 and what are the 4 Subparts?

Back 2

Protection of Human Subjects

A. General Provisions

B. Informed Consent of Human Subjects

C. [Reserved]

D. Additional Safeguards for Children

Front 3

What is 21CFR50.20 Subpart B?

Back 3

General Requirements for Informed Consent

Front 4

What is 21CRF50.23 Subpart B?

Back 4

Exception from General Requirements

Front 5

What is necessary to satisfy 21CFR50.23 Subpart B?

Back 5

A.) Informed Consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from the subject.

B.) The human subject is confronted by a life-threatening situation necessitating the use of the test article.

C.) Time is not sufficient to obtain consent from the subjects legal representative.

D.) There is no available alternative method of treatment approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject

Front 6

What is 21CFR50.24 Subpart B?

Back 6

Exceptions from Informed Consent Requirements for Emergency Research

Front 7

What is necessary to satisfy 21CFR50.24 Subpart B?

Back 7

A. The human subjects are in a life threatening situation, avaliable treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness particular interventions.

B.) The clinical investigation could not practically be carried out without the waiver

C.) Obtaining informed consent is not feasible- as described in 21CFR50.24 (a)

D.) Participation in the research holds out the prospect of direct benefit to the subjects- as described in 21CFR50.24 (a)

E. The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator, has committed to attempting to contact legally authorized representative for each subject within that window of time, and if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent.

Front 8

What is 21CFR50.25 Subpart B?

Back 8

Basic Elements of Informed consent

Front 9

List BASIC Elements of Informed Consent under Section 21CFR50.25 Subpart B?

Back 9

A.) An explanation of whom to contact for answers to pertinent questions about the research and research subjects rights and whom to contact in the event of a research - related injury

B.) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

C.) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect the records.

D.) A description of any reasonable foreseeable risks or discomforts to the subject.

E.) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are avaliable if injury occurs, and if so, what they consist of, or where further information may be obtained.

F.) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subjects participation, a description of the procedures to be followed, and identification for any procedures which are experimental.

G.) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject otherwise entitled, and that the subject may discontinue participation at any time with out penalty or loss of benefits to which the subject is otherwise entitled.

H.) A description of any benefits to the subject or to others which may reasonably be expected from the research

Front 10

What is 21CFR50.50 Subpart D?

Back 10

IRB Duties

Front 11

What is 21CFR50.51 Subpart D?

Back 11

Clinical investigations not involving greater than minimal risk

Hint 11

46.404

Front 12

What is 21CFR50.53 Subpart D?

Back 12

Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely yield generalizable knowledge about the subject's disorder or condition

Hint 12

46.406

Front 13

What is 21CFR50.27 Subpart B?

Back 13

Documentation of Informed Consent

Front 14

What is 21CFR50.54 Subpart D?

Back 14

Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

Hint 14

46.407

Front 15

What is 21CFR50.55 Subpart D?

Back 15

Requirements for permission by parents or gardians and for assent by children.

Front 16

What is 21CFR50.52 Subpart D?

Back 16

Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects-children

Hint 16

46.405

Front 17

What is 21CFR50.56 Subpart D?

Back 17

Wards

Front 18

What is 21 CFR Part 56 and what are the 5 Subparts?

Back 18

Institutional Review Boards

A. General Provisions

B. Organization and Personal

C. IRB Functions and Operations

D. Records and Reports

E. Administrative Actions for Noncompliance

Front 19

What is 21CFR56.104 Subpart A?

Back 19

Exemptions from IRB Requirement

Front 20

What is 21CFR56.105 Subpart A?

Back 20

Waiver of IRB Requirement

Front 21

What is 21CFR56.106 Subpart B?

Back 21

Registration

Front 22

What is 21CFR56.107 Subpart B?

Back 22

IRB Membership

Front 23

What is 21CFR56.108 Subpart C?

Back 23

IRB Functions and Operations

Front 24

What is 21CFR56.109 Subpart C?

Back 24

IRB Review of Research

Front 25

What is 21CFR56.110 Subpart C?

Back 25

Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research

Front 26

What is 45 CFR Part 46 and what are the 5 Subparts?

Back 26

Public Welfare

A. Basic HHS policy for protection of human research subjects

B. Additional protections for pregnant women, human fetuses and neonates involved in research

C. Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects.

D. Additional protections for children involved as subjects in research

E. Registration of institutional review boards

Front 27

What is 21CFR 312 and what are it's Subparts?

Back 27

A. General Provisions

B. Investigational New Drug Application

C. Administrative Actions

D. Responsibilities of Sponsors and Investigators

E. Drugs Intended to Treat Life-threatening and Severely - debilitating Illnesses

F. Miscellaneous

G. Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests

H. [Reserved]

I. Expanded Access to Investigational Drugs for Treatment Use

Front 28

21 CFR Part 56 Subpart D- IRB Records and Reports.

56.115 IRB Records

The records required by this regulation shall be retained for at least __________ after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the FDA at reasonable times and in a reasonable manner.

Back 28

3 years