21 code of federal regulations Flashcards
21 pt 11 is what CFR
electronic records; electronic signatures
Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(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.
Electronic signatures that are not based upon biometrics shall:
(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
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:
(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.
What is 21 pt 50
Informed consent / Protections of human subjects
(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:
(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.
What are basic elements of an ICF
(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.
When using a short from for ICF who are all required to be there?
Witness
Subject
PErson obtaining consent
What does the witness, subject and person obtaining consent sign for short form ICF
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
Subpart D for 21 ICF 56 is what?
Additional safeguards for children in clinical trials
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?
(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
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?
(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
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?
(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
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?
(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
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?
(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