Investigational New Drug (IND) Flashcards
A 1572 is a contract between:
a) IRB and FDA
b) Investigator and FDA
c) Sponsor and FDA
d) Sponsor and institution
b) Investigator and FDA
According to FDA regulations, the investigator brochure must be:
a) Given by the sponsor to the IRB
b) Given by the investigator to the IRB
c) Given by the sponsor to the investigator
d) Given by the sponsor to the CRO
c) Given by the sponsor to the investigator
Which of the following is not a commitment made by the investigator on a 1572 form to the FDA?
a) Supervise all associates and colleagues
b) Adhere to the IRB approved protocol
c) Ensure IRB review of protocol and any changes
d) Not enter into any financial arrangement with the sponsor
e) Inform patients that the drugs are investigational
d) Not enter into any financial arrangement with the sponsor
Which of the following is an FDA mandated responsibility that represents the investigator’s responsibility to the sponsor?
a) Submission of an updated 1572
b) Completion of a delegation log
c) Retention of records for three years
d) Update the investigator’s CV annually
a) Submission of an updated 1572
All of the following items are required on a Form 1572 except:
a) The principal investigator’s CV
b) Information on sub investigators
c) Laboratory facilities utilized
d) IRB information
e) Financial disclosures of the principal investigator
e) Financial disclosures of the principal investigator
The investigators brochure is a central part of the submission of an IND:
a) Form 1571
b) Form 1572
c) Form 3455
d) MedWatch Form 3500 A
a) Form 1571
A Form 1571 includes all of the following items except:
a) The protocol
b) The investigator’s brochure
c) A chemistry manufacturing and controls section
d) Pharmacology and toxicology data
e) Financial disclosure of the sponsor
e) Financial disclosure of the sponsor
An IND is needed for all of the following except:
a) A new chemical entity
b) A new or unapproved indication
c) A new dosage form or dosage level or new drug combination
d) Off label use at the discretion of a physician
d) Off label use at the discretion of a physician
An IND is not needed for all of the following except:
a) An application not intended for human use
b) In vitro testing
c) Laboratory animal studies
d) Use of a drug on label
e) A contemplated new marketing application
e) A contemplated new marketing application
A study may be approved for an IND exemption for all of the following except:
a) The study will not pursue a new indication
b) The study will not pursue a change in the labeling or advertising
c) The study will not involve a new population
d) The study will not adhere to an approved route of administration or dosage level.
d) The study will not adhere to an approved route of administration or dosage level.
The following reports should be filed as needed or promptly with the FDA by the sponsor except:
a) Annual report
b) Adverse event report
c) Protocol amendments
d) Change in the IRB roster
d) Change in the IRB roster
The sponsor’s decision to use a CRO should be declared in:
a) Form 1571
b) Form 1572
c)Form 3455
d) Medwatch Form 3500 A
a) Form 1571
For an adverse event to be reported to the FDA it must be:
a) Serious
b) Serious and unanticipated
c) Serious, unanticipated and possibly related
d) Serious, unanticipated and probably related.
c) Serious, unanticipated and possibly related
A sponsor may charge a subject for an investigational drug:
a) If the sponsor’s budget needs it
b) If the drug is expensive
c) If the institution agrees
d) With written permission from the FDA.
d) With written permission from the FDA.
A sponsor investigator must complete the following forms for the FDA at the initiation of a clinical trial I:
a) Form 1571 only
b) Form 1572 only
c) Form 1571 and Form 1572
d) Medwatch form 3500 A
c) Form 1571 and Form 1572
