copied cards Flashcards
What does 21 CFR Part 11 cover?
Electronic Records; Electronic Signatures
What is a closed system?
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
What is an open system?
An environment in which system access is NOT controlled by persons who are responsible for the content of electronic records taht are on the system.
What is a digital signature?
It is an electronic signature based on crypotgraphic methods of originator authentication, computer by using a set of rules and set of parameters such that the identity of the signer and the integrity of the data can be verified.
What is an electronic signature?
it is a computer data compilation of any symbol or series of symbols executed, adopted, or digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
What is a handwritten signature?
a scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.
What does biometrics mean?
it is a method of verifying an individual’s identity based on measurement of the individual’s physical features or repeatable actions wehre those features and/or actions are both unique to that individual and measureable.
Act means…
The Federal Food, Drug, and Cosemetic Act
Agency means…
Food and Drug Administration
General Requirements for electonric signatures are..
1) Each electronic signature should be unique & shall not be reused or reassigned to anyone else. 2) Before the organization certifies the signature they have to verify the identity of the individual. 3) Persons shall certify that electronic signatures used after 20AUG1997 are legally binding.
Electronic signatures NOT based on biometrics shall
1) employ at least two distinct identification components (ID code and password). 2) be used only by genuine owners. 3) use of the signature by anyone other than its genuine owner requires collaboration of two or more individuals.
Electronic signatures that ARE based on biometrics shall
be designed to ensure that they cannot be used by anyone other than their genuine owner.
Controls for ID codes and passwords shall include these 5 components:
1) maintain the uniqueness of each ID code and pw 2) Ensure that the ID code and pw ussuances are periodically checked, recalled, or revised. 3) Following loss management procedures to electronically deauthorize lose, stolen, missing or otherwise potentially compromised tokens, cards, and other devices. 4) use of transaction safeguards to prevent unauthorized use of pws and/or ID codes 5) initial and periodic testing of devices that bear or generate id code or pw info.
What does 21 CFR Part 50 cover?
Protection of Human Subjects
Clinical Investigation means..
any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the FDA or is not subject to requirements for prior submission to the FDA but the results of which are intended to be submitted later to or held for inspection by the FDA as part of an application for a research or marketing permit.
Sponsor
person who initiates a clinical investigation, but who does not actually conduct the investigation.
Sponsor-Investigator
individual who both initiates and actually conducts, alone or with others, a clinical investigation.
Exceptions from informed consent for emergency research
1) subject is in a life-threatening situation and collection of valid scientific evidence is necessary to determine safety and effectiveness of particular interventions. 2) Obtaining consent is not feasible. 3) Participation in the research holds out the prospect of direct benefit. 4) The clinical investigation could not practicably be carried out without the waiver. 5) the tx plan makes sense and the investigator is doing what he/she can to contact a legally authorized rep. 6) IRB has approved 7) additional protections of the rights and welfare of the subjects will be provided
Elements of informed consent
1) statement that the study involved research. 2) description of any reasonably foreseeable risks or discomforts to the subject. 3) description of any benefits to the subject or others. 4) disclosure of alternative procedures. 5) statement describing the extent to which confidentiality of records will be maintained 6) statement regarding compensation and medical tx if any injury. 7) who to contact for answers to pertinent questions about research and subjects rights. 8) participation is voluntary.
Additional elements of informed consent
1) statement that the particular tx may involve additional risk to the subject. 2) anticipated circumstances under which participation may be terminated. 3) any additional costs. 4) consequences of a subjects decision to withdraw. 5) statement that significant findings during the research will be provided. 6) approximate number of subjects involved in the study.
Each IRB should have at least how many members?
5
Each IRB shall include:
1 member whose primary concerns are in the scientific area and 1 whose primary concerns are in nonscientific areas, and 1 who is not otherwise affiliated with the institution.
Criteria for IRB approval
- Risks to subjects are minimized. 2. Risks to subjects are reasonable in relation to anticipated benefits. 3. Selection of subjects is equitable. 4. informed consent from each subject. 5. informed consent should be documented. 6. research plan makes adequate provision for monitoring the data collected. 7. adequate provisions to protect the privacy of subjects and to maintain confidentiality of subjects.
test article
any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the public health service act.