21 code of federal regulations

Question 1

21 pt 11 is what CFR

Answer 1

electronic records; electronic signatures

Question 2

Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

Answer 2

(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

Question 3

Electronic signatures that are not based upon biometrics shall:

Answer 3

(1) Employ at least two distinct identification components such as an identification code and password.
(2) Be used only by their genuine owners; and
(3) Be administered and executed to ensure that attempted use of an individual’s electronic signature by anyone other than its
genuine owner requires collaboration of two or more individuals

Question 4

Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ
controls to ensure their security and integrity. Such controls shall include:

Answer 4

(a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the
same combination of identification code and password.
(b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover
such events as password aging).
(c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially
compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue
temporary or permanent replacements using suitable, rigorous controls.
(d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and
report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate,
to organizational management.
(e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password
information to ensure that they function properly and have not been altered in an unauthorized manner.

Question 5

What is 21 pt 50

Answer 5

Informed consent / Protections of human subjects

Question 6

(a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in
paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation
certify in writing all of the following:

Answer 6

(1) The human subject is confronted by a life-threatening situation necessitating the use of the test article.
(2) Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally
effective consent from, the subject.
(3) Time is not sufficient to obtain consent from the subject’s legal representative.
(4) There is available no alternative method of approved or generally recognized therapy that provides an equal or greater
likelihood of saving the life of the subject.

Question 7

What are basic elements of an ICF

Answer 7

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of
the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are
experimental.
(2) A description of any reasonably foreseeable risks or discomforts to the subject.
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research.
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the
subject.
(5) 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 Food and Drug Administration may inspect the records.
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to
whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be
obtained.
(7) 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 to the subject.
(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to
which the subject is otherwise entitled.

Question 8

When using a short from for ICF who are all required to be there?

Answer 8

Witness
Subject
PErson obtaining consent

Question 9

What does the witness, subject and person obtaining consent sign for short form ICF

Answer 9

Short form is signed by subject

Witness signs both short form and a copy of the summary

Person actually obtaining the consent shall signa copy of the summary

Question 10

Subpart D for 21 ICF 56 is what?

Answer 10

Additional safeguards for children in clinical trials

Question 11

Any clinical investigation with no greater than minimal
risk to children is presented may involve children as subjects only if the IRB finds that:

what section is this related to?

Answer 11

(a) No greater than minimal risk to children is presented; and
(b) Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians

50.51

Question 12

Any clinical investigation with more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a
monitoring procedure that is likely to contribute to the subject’s well-being, may involve children as subjects only if the IRB finds
that:

what section is this related to?

Answer 12

(a) The risk is justified by the anticipated benefit to the subjects;
(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available
alternative approaches; and
(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians

50.52

Question 13

Any clinical investigation with more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject,
or by a monitoring procedure that is not likely to contribute to the well-being of the subject, may involve children as subjects only if
the IRB finds that:

what section is this related to?

Answer 13

(a) The risk represents a minor increase over minimal risk;
(b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in
their actual or expected medical, dental, psychological, social, or educational situations;
(c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition that is of
vital importance for the understanding or amelioration of the subjects’ disorder or condition; and
(d) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians

50.53

Question 14

If an IRB does not believe that a clinical investigation within the scope described in §§50.1 and 56.101 of this chapter and
involving children as subjects meets the requirements of §50.51, §50.52, or §50.53, the clinical investigation may proceed only if:

What section is this?

Answer 14

(a) The IRB finds that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or
alleviation of a serious problem affecting the health or welfare of children; and
(b) The Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent disciplines (for example:
science, medicine, education, ethics, law) and following opportunity for public review and comment, determines either:
(1) That the clinical investigation in fact satisfies the conditions of §50.51, §50.52, or §50.53, as applicable, or
(2) That the following conditions are met:
(i) The clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a
serious problem affecting the health or welfare of children;
(ii) The clinical investigation will be conducted in accordance with sound ethical principles; and
(iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents

50.44

Question 15

The assent of the children is not a necessary condition for proceeding with the clinical investigation if the IRB determines:

Which section does this refer too?

Answer 15

(1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted, or

(2) That the intervention or procedure involved in the clinical investigation holds out a prospect of direct benefit that is
important to the health or well-being of the children and is available only in the context of the clinical investigation.

50.55

Question 16

Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement
if it finds and documents that:

Answer 16

(1) The clinical investigation involves no more than minimal risk to the subjects;
(2) The waiver will not adversely affect the rights and welfare of the subjects;
(3) The clinical investigation could not practicably be carried out without the waiver; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Question 17

Under 50.51 or 50.52 how many parents will need to grant permission

Answer 17

one

Question 18

Where clinical investigations are covered by §50.53 or §50.54 and permission is to be obtained from parents how many parents need to give consent?

Answer 18

both

Question 19

What is 50.56

Answer 19

Wards

Question 20

(a) Children who are wards of the State or any other agency, institution, or entity can be included in clinical investigations
approved under §50.53 or §50.54 only if such clinical investigations are:

Answer 20

(1) Related to their status as wards; or
(2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as
subjects are not wards.

Question 21

(b) If the clinical investigation is approved under paragraph (a) of this section, the IRB must require appointment of an
advocate for each child who is a ward.

Answer 21

(1) The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis.
(2) One individual may serve as advocate for more than one child.
(3) The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best
interest of the child for the duration of the child’s participation in the clinical investigation.
(4) The advocate must not be associated in any way (except in the role as advocate or member of the IRB) with the clinical
investigation, the investigator(s), or the guardian organization.

Question 22

The following categories of clinical investigations are exempt from the requirements of this part for IRB review:

Answer 22

a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA
regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA
requirements in effect before July 27, 1981.
(b) Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under
Food and Drug Administration regulations before that date.
(c) Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any
subsequent use of the test article at the institution is subject to IRB review.
(d) Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed
or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural,
chemical, or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved
by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Question 23

What is 56.105

Answer 23

waive of IRB requirement

Question 24

who must register for an IRB

Answer 24

Each IRB in the United States that reviews clinical investigations regulated by FDA under sections
505(i) or 520(g) of the act and each IRB in the United States that reviews clinical investigations that are intended to support
applications for research or marketing permits for FDA-regulated products must register at a site maintained by the Department of
Health and Human Services (HHS).

Question 25

what research permit under section 505(i) of the act?

Answer 25

an investigational new
drug application (IND)

Question 26

what research permit under section 520(g) of the act

Answer 26

an investigational device
exemption (IDE).

Question 27

what info must an IRB register?

Answer 27

(1) The name, mailing address, and street address (if different from the mailing address) of the institution operating the IRB
and the name, mailing address, phone number, facsimile number, and electronic mail address of the senior officer of that
institution who is responsible for overseeing activities performed by the IRB;
(2) The IRB’s name, mailing address, street address (if different from the mailing address), phone number, facsimile number,
and electronic mail address; each IRB chairperson’s name, phone number, and electronic mail address; and the name, mailing
address, phone number, facsimile number, and electronic mail address of the contact person providing the registration
information.
(3) The approximate number of active protocols involving FDA-regulated products reviewed. For purposes of this rule, an
“active protocol” is any protocol for which an IRB conducted an initial review or a continuing review at a convened meeting or
under an expedited review procedure during the preceding 12 months; and
(4) A description of the types of FDA-regulated products (such as biological products, color additives, food additives, human
drugs, or medical devices) involved in the protocols that the IRB reviews.

Question 28

When must an IRB register?

Answer 28

Each IRB must submit an initial registration. The initial registration must occur before the IRB
begins to review a clinical investigation described in paragraph (a) of this section. Each IRB must renew its registration every 3
years. IRB registration becomes effective after review and acceptance by HHS.

Question 29

Where can an IRB reigster?

Answer 29

Each IRB may register electronically through http://ohrp.cit.nih.gov/efile. If an IRB lacks the
ability to register electronically, it must send its registration information, in writing, to the Office of Good Clinical Practice, Office of
Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD
20993.

Question 30

If an IRB’s contact or chair person information changes, the IRB must
revise its registration information by submitting any changes in that information within ____ days of the change.

Answer 30

90

Question 31

An IRB’s decision to
review new types of FDA-regulated products (such as a decision to review studies pertaining to food additives whereas the IRB
previously reviewed studies pertaining to drug products), or to discontinue reviewing clinical investigations regulated by FDA is a
change that must be reported within _____days of the change.

Answer 31

30

Question 32

An IRB’s decision to disband is a change that must be reported within _____ days of permanent cessation of the IRB’s review of research. All other information changes may be reported when the IRB
renews its registration

Answer 32

30

Question 33

What is 56.110

Answer 33

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

Question 34

An IRB may use the expedited review procedure to review either or both of the following:

Answer 34

(1) Some or all of the research
appearing on the list and found by the reviewer(s) to involve no more than minimal risk,

(2) minor changes in previously approved
research during the period (of 1 year or less) for which approval is authorized.

Question 35

What is 56.111

Answer 35

(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do
not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the
subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the
knowledge that may be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits
that may result from the research (as distinguished from risks and benefits of therapies that subjects would receive even if not
participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the
research (for example, the possible effects of the research on public policy) as among those research risks that fall within the
purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the
research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of
research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disabled
persons, or economically or educationally disadvantaged persons.
(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in
accordance with and to the extent required by part 50.
(5) Informed consent will be appropriately documented, in accordance with and to the extent required by §50.27.
(6) Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of
subjects.
(7) Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
data.

Question 36

what is 56.115

Answer 36

IRB records

Question 37

(a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities,
including the following:

Answer 37

(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample
consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB;
the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in
or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as
board certifications, licenses, etc., sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and
any employment or other relationship between each member and the institution; for example: full-time employee, part-time
employee, a member of governing panel or board, stockholder, paid or unpaid consultant.
(6) Written procedures for the IRB as required by §56.108 (a) and (b).
(7) Statements of significant new findings provided to subjects, as required by §50.25.