certification program reference manual Flashcards
Signed electronic records shall contain information associated with the signing that clearly indicates all (3) 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.
Obtaining informed consent shall be deemed feasible unless both the investigator and a physician who is not otherwise participating in the clinical investigation
certify in writing all (4) 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.
If immediate use of the test article is, in the investigator’s opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent physician’s determination in advance of using the test article, what must happen?
The determinations of the clinical investigator shall be made and, within 5 working days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. Documentation should be submitted to IRB 5 days after using test article.
When may the President waive the prior consent requirement for the administration of an
investigational new drug to a member of the armed forces in connection with the member’s participation in a particular military operation?
President determines in writing that obtaining consent: Is not feasible; is contrary to the best interests of the military member; or is not in the interests of national security
For DOD IND, the duly constituted institutional review board must include how many nonaffiliated members who shall not be employees or officers of the Federal Government?
At least three nonaffiliated members who shall not be employees or officers of the Federal Government.
How often must the IRB renew its registration?
Every 3 years.
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 how many days of change?
Within 30 days of the change.
An IRB’s decision to disband is a change that must be reported within how many days of the change?
Within 30 days of permanent cessation of the IRB’s review of research.
Each IRB must have at least how many members?
At least five members, with varying backgrounds to promote complete and adequate review of
research activities commonly conducted by the institution.
What is a phase I study?
(1) Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80.
(2) Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease
processes.
What is a phase II study?
Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a
relatively small number of patients, usually involving no more than several hundred subjects.
What is a phase III study?
Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness
and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects.
The sponsor must notify FDA and all participating investigators of an IND safety report within how many days?
15 calendar days.
Which FDA form is used to submit IND safety reports?
FDA Form 3500A.
When must the sponsor must notify FDA of any
unexpected fatal or life-threatening suspected adverse reaction?
As soon as possible but in no case later than 7 calendar days after the sponsor’s initial receipt of the information.
