1 CRF Part 312 – Investigational New Drug Application

Question 1

Is a new drug in accordance with part 312 is exempt from the premarketing approval requirements and may be shipped lawfully for the purposes of the trial?

Answer 1

True

Question 2

What is 21 CRF Part 312 regarding?

Answer 2

IND: Investigational New Drug

Question 3

NEW INVESTIGATIONAL DRUG can be distributed commercially in a test market

Answer 3

False

Question 4

Charging for an investigational new drug in a clinical trial is permitted without approval from the FDA unless the drug is being provided for treatment use.​

Answer 4

False

Question 5

Which factors are considered when determining whether a clinical trial should be conducted?

Answer 5

The predicted risk or benefit associated with a drug’s use​, The number of participants needed in a study to obtain valid results​, The cost associated with conducting the trial

Question 6

How many days will the FDA take to provide written determination of receiving an IN?

Answer 6

30 days

Question 7

Phase 1 of a Trial

Answer 7

It is the FDA’s responsibility to ensure the SAFETY of subjects

Question 8

Phase 2 & 3 trials

Answer 8

it is the FDA’s responsibility to ensure the SAFETY and the DRUG’S EFFECTIVENESS​

Question 9

Phase 4

Answer 9

Post Market Safety & Efficacy

Question 10

An unexpected death of a subject while participating in a clinical trial which is considered possibly related to the drug being tested should be reported to the FDA:

Answer 10

As soon as possible but no later than 7 days after notification of the event.​

Question 11

To obtain a notice of exemption of IND requirements from the FDA for a particular clinical study, the sponsor of the potential IND should:

Answer 11

Submit the IND application and wait 30 days

Question 12

The sponsor must wait _____ calendar days after IND submission before initiating research activities in support of an Investigational New Drug application (IND).

Answer 12

30 days

Question 13

Sponsor has how many days to notify the FDA if a PI is added

Answer 13

30 days

Question 14

The sponsor must notify the FDA of any unexpected fatal or life-threatening experience associated with the use of the drug

Answer 14

as soon as possible but not later than 7 calendar days after the sponsor’s initial receipt of the information. ​

Question 15

Sponsors must provide written notification to the FDA and to all investigators participating in a trial within

Answer 15

15 calendar days of any adverse event that is Both serious and unexpected, and reasonably likely to have been caused by the investigational new drug.

Question 16

within how many days of the INDs effective date anniversary will the sponsor need to submit a what?

Answer 16

60 days of a brief progress report

Question 17

When must an investigational new drug application (IND) be submitted according to 21 CFR 312?

Answer 17

When initiating any clinical investigations involving a new drug

Question 18

What type of data is required when submitting an investigational new drug application (IND)?

Answer 18

Clinical data from past trials involving similar products, Data on animal testing conducted using the proposed product, Data on manufacturing processes used during development

Question 19

What type of review process takes place after submission of an investigational new drug application (IND)?

Answer 19

Statistical analysis using collected clinical data, A comprehensive evaluation by FDA regulatory experts, Approval from Institutional Review Board (IRB)

Question 20

FDA can issue a “ “ at any time to delay or suspend a current trial

Answer 20

Clinical Hold

Question 21

Grounds for imposition of a clinical hold include the following:

Answer 21

The investigator’s brochure is misleading, The IND does not contain sufficient info to assess risk

Question 22

If no subjects are enrolled after X years, or if the trial has been on a clinical hold for X year, the FDA can place the trial on what

Answer 22

2 years, 1 year, Inactive status

Question 23

A trial that is in inactive status for X years, will be what

Answer 23

5 years, terminated

Question 24

312.54 chapter 50.24

Answer 24

The sponsor shall monitor any subject that was treated under “emergency use”​

Question 25

Sponsors shall ensure PIs are abiding by the investigator statement on which form

Answer 25

1572

Question 26

Sponsor shall recall all stock and discontinue clinical trial how soon if Sponsor determines the drug presents unreasonable risk to subjects.

Answer 26

as soon as possible but no later than 5 working days after making the determination of discontinuance​

Question 27

Sponsor shall maintain adequate records for how many years

Answer 27

2

Question 28

Section 312.305 is for what

Answer 28

Expanded Access or Compassionate Use

Question 29

Section 312.320 is for what

Answer 29

Treatment IND/Protocol

Question 30

Section 314.101 is for what

Answer 30

marketing application

Question 31

The FDA will accept as support for an IND or application for marketing approval, a well-designed and well-conducted foreign clinical study not conducted under an IND, if the following conditions are met:

Answer 31

The FDA can validate the data from the study through an onsite inspection if the agency deems it necessary, The study was conducted in accordance with good clinical practice (GCP)

Question 32

In an emergency, where there is not sufficient time to secure IRB review prior to beginning treatment, the emergency use of the investigational drug must be reported to the IRB within X working days, as required under what part ?

Answer 32

5 working days, 21 CFR 56.104(c).

Question 33

The sponsors request for a regulatory hearing must be made within ___ of the sponsors receipt of FDA’s notification of nonacceptance.

Answer 33

10 days

Question 34

True or False. FDA Form 1572 is required for all trials.

Answer 34

False. Form 1572 is required for IND studies but not required for IDE. A generic doctor agreement is all that is required for IDE.

Question 35

Fatal or life-threatening unexpected adverse drug reactions are required to be reported no later than how many days after first knowledge?

Answer 35

7 calendar days after first knowledge

Question 36

non-life-threatening unexpected or adverse drug reactions are required to be reported no later than how many days after first knowledge?

Answer 36

15 calendar days after first knowledge

Question 37

For emergency use of a drug, where immediate use of the product was required and the patient was not able to be consented, how long does the sponsor have to notify the FDA of the use of the product?

Answer 37

5 working days