Title 21, Part 312 - Investigational New Drug Application (IND) Flashcards
Contract Research Organization
Definition ONLY
a person that assumes, as an indpendent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection of monitoring of investiations, evaluation of reports, and the preparation of materials to be submitted to the Food and Drug Administration
Act
Definition ONLY
Federal Food, Drug, and Cosmetic Act
Independent Ethics Committee (IEC)
Definition ONLY
a review panel that is responsible for ensuring the protection of the rights, safety, and well-bbeing of human subjects involved in a clinical investigation
*An IRB is one type of IEC
Investigator
Definition ONLY
an individual that actually conducts a clinical investigation
Sponsor
Definition ONLY
an individual who takes responsibility for and initiates a clinical investigation
Direct Costs
Definition ONLY
costs incurred by a sponsor that can be specfically and exclusively attributed to providing the drug for the investigational use for which FDA has authorized cost recovery
Indirect Costs
Definition ONLY
costs incurred primarily to produce the drug for commerical sale (e.g., costs for facilities and equipment used to manufacture the supply of the investigational drug
Who submits IND to FDA
Sponsor submites IND to FDA if the sponsor intends to conduct a clinical investigtion with an investigational new drug
How many Phases of an Investigation can an IND be submitted for?
IND may be submitted for one or more phases of an investigation
Phase 1
-introduction of drug to human subjects
-tests for safety, dosage
-studies are usually closely monitored
-20 - 80 subjects
Phase 2
-tests for efficacy and side effects of the drug
-usually well controlled, closely monitored, and conducted in a small number of subjects (no more than several hundred subjects)
Phase 3
-tests for effectiveness
-compares drug to other standard treatments
-involves several hundred to several thousand subjects
What is the FDA’s primary objective in reviewing an IND?
-Assuring the **safety and rights of subjects **
-Assure the quality of the scientific evaluation
IND Application -
Order of Contents Within Application
Order of Contents Within Application
1) Cover Sheet
2) Table of Contents
3) Introductory Statement and General Investigational Plan
4) [reserved]
5) Investigator’s Brochure
6) Protocols
7) Chemistry, Manufacturing, and Control Information
8) Pharmacology and Toxicology Information
9) Previous human experience with the investigational drug
10) Additional Information
11) Relevant Information
IND Protocol Amendments
-Sponsor submits any amendments
-A protocol amendment will need to be submitted for any change in:
1)Phase 1 protocol that significantly affects the safety of subjects
2)Phase 2 or 3 protocols that significantly affect the safety of subjects, the scope of the investigation, or the scientific quality of the study
IND Safety Reporting
Adverse event
Definition ONLY
-Any untoward medical occurrence associated with the use of a drug in humans, whether or not considred drug related
IND Safety Reporting
Life-Threatening Adverse Event or Life-Threatening Suspected Adverse Reaction
Definition ONLY
-Considered “life-threatening” if, in the view of the investigator or sponsor, its occurrence places the patient or subject at immediate risk of detath
*Does not include an adverse event that, that it occurred in a more seve
IND Safety Reporting
Serious Adverse Event or Serious Suspected Adverse Reaction
Definition ONLY
An event/reaction is considered serious if any of the following happens:
1) death,
2) a life-threatening adverse event,
3) inpatient hospitalization,
4) persistent incapacity or disruption to conduct normal life functions,
4) a congenital anomoly/birth defect
IND Safety Reporting
Suspected Adverse Reaction
Definition ONLY
-Any adverse reaction which there is a reasonable possibility that the drug caused the adverse event
*reasonable possiblity suggests a causal relationship b/t the drug and a
IND Safety Reporting
Unexpected Adverse Event or Unexpected Suspected Adverse Reaction
Definition ONLY
-Unexpecrted if the reaction/event is..
1) not listed in the IB or not listed at the specificity or severity that has been observed
2) the IB is not required or available
3) not consistent with the risk information described in the investigation plan
IB - investigator’s brochure
Who notifies the FDA about safety reports and when?
The sponsor most notify FDA and all participating investigators ASAP or no later than 15 calendar days after the sponsor determines the information is qualified to report
When should Unexpected fatal or life-threatening suspected adverse reaction reports be submitted? Who reports to who?
-The sponsor must notify FDA ASAP, or no later than 7 calendar days from the sponsor’s initial reciept of the information
Who submits an Annual Report and When?
-A sponsor shall submit an annual report within 60 days of the anniversary date that the IND went into effect
Who can withdraw an IND application?
A sponsor may withdraw an IND at any time
