21 CRF 312 Flashcards
Transfer of responsibility from sponsor to contract research organization (CRO)
A sponsor may transfer responsibility of any or all of its obligations to a contract research organization
if not all obligations are transferred, the writing is required to describe each of the obligations being assumed by the CRO.
any obligations not covered by the written description shall be deemed not to have been transferred
Form FDAs included in an IND application
- FDA Form 1572 – Statement of Investigator
- FDA Form 1571 – Investigational New Drug
For INDs that require an exception from informed consent under 21CFR50.24, a separate IND is required by …
Sponsor or CRO if all Sponsor obligations are transferred to the CRO
Which Phase?
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.
Phase 1
Which phase?
sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained. Total number of subjects and patients varies with the drug, but is generally in the range of 20 to 80.
Phase 1
Which phase?
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
Which phase?
Expanded controlled and uncontrolled trials. 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. Usually include several hundred to several thousand participants
Phase 3
Outcomes that define serious adverse event or serious suspected adverse reaction
a. Death
b. Life-threatening adverse event
c. Inpatient hospitalization or prolongation of existing hospitalization
d. A persistent or significant incapacity or disability
e. A congenital anomaly/birth defect
Which FDA form is completed to report IND safety reports (that are unexpected fatal or life- threatening suspected adverse reaction) by a manufacturer
Form FDA 3500A
Definition of “unexpected”
Adverse events or suspected adverse reactions that are mentioned in the IB as occurring with a class of drugs
or as anticipated from the pharmacological properties of the drug but are not specifically mentioned as occurring with the particular drug under investigation
Who is responsible for retaining records and reports required by this part for how many years after a marketing application is approved for a drug; or, if an application is not approved, until how many heat after shipment and delivery of the drug for investigational use is discontinued and FDAhas been notified
Sponsor or investigator
2 years, 2 years
Who shall obtain a commitment from whom to promptly update financial disclosure information if any relevant changes occur during the course of the investigation and for how long following the completion of the study
Sponsor, clinical investigator, 1 year
Whose responsibility is it to ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed about obligations in meeting the trial commitments
Investigator
Which phase?
include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans. studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes
Phase 1
Which phase?
well controlled, closely monitored, conducted in a relatively small number of patients, usually involving no more than several hundred
Phase 2
