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SOCRA 2024 Flashcards > 1 CRF Part 312 – Investigational New Drug Application > Flashcards

1 CRF Part 312 – Investigational New Drug Application Flashcards

1
Q

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?

A

True

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2
Q

What is 21 CRF Part 312 regarding?

A

IND: Investigational New Drug

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3
Q

NEW INVESTIGATIONAL DRUG can be distributed commercially in a test market

A

False

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4
Q

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.​

A

False

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5
Q

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

A

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

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6
Q

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

A

30 days

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7
Q

Phase 1 of a Trial

A

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

Typically 20-80 people

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8
Q

Phase 2 & 3 trials

A

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

Phase 2: Typically a few dozen to 300 people; further evaluate safety and effectiveness
Phase 3: Several hundred to 3000 people; safety and efficacy, confirm effectiveness and monitor safety.

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9
Q

Phase 4

A

Post Market Safety & Efficacy; gather info on drugs effect in various populations and any side effects associated with long term use.

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10
Q

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:

A

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

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11
Q

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

A

Submit the IND application and wait 30 days

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12
Q

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

A

30 days

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13
Q

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

A

30 days

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14
Q

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

A

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

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15
Q

Sponsors must provide written notification to the FDA and to all investigators participating in a trial within X Days of any adverse event that is both serious and unexepected, and reasonably likely to have been caused by the investigational new drug.

A

15 calendar days

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16
Q

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

A

60 days of a brief progress report

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17
Q

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

A

When initiating any clinical investigations involving a new drug

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18
Q

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

A

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

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19
Q

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

A

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

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20
Q

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

A

Clinical Hold

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21
Q

Grounds for imposition of a clinical hold include the following:

A

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

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22
Q

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

A

2 years, 1 year, Inactive status

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23
Q

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

A

5 years, terminated

24
Q

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

A

1572

25
Q

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

A

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

26
Q

Sponsor shall maintain adequate records for how many years

A

2

27
Q

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:

A

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)

28
Q

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 ?

A

5 working days, 21 CFR 56.104(c).

29
Q

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

A

10 days

30
Q

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

A

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

31
Q

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

A

7 calendar days after first knowledge

32
Q

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

A

15 calendar days after first knowledge

33
Q

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?

A

5 working days

34
Q

Can you charge for an IND?

A

session#5 slide 10; Charging for an investigational new drug in a clinical trial is not permitted without approval from the FDA unless the drug is being provided for treatment use.

35
Q

FDA gives authorization to ship only if it’s labelled appropriately “XXXX”

A

“not for use in humans”

36
Q

The immediate package of an investigational new drug intended for human use shall bear a label with the statement

A

“Caution: New Drug—Limited by Federal (or United States) law to investigational use.”

37
Q

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

​

A . Statistical analysis using collected clinical data ​

​

B .A comprehensive evaluation by FDA regulatory experts ​

​

C .Approval from Institutional Review Board (IRB) ​

​

D .All of the above

A

D .All of the above

38
Q

Can a sponsor or investigator commercially distribute or test market an IND?

A

NO

39
Q

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

​

A. When initiating any clinical investigations involving a new drug​

​

B. When submitting new marketing applications for a drug product​

​

C .When introducing any changes to an approved drug product​

​

D .All of the above

A

A. When initiating any clinical investigations involving a new drug​

40
Q

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

A . Clinical data from past trials involving similar products ​

​

B .Data on animal testing conducted using the proposed product ​

​

C .Data on manufacturing processes used during development ​

​

D .All of the above

A

D .All of the above

41
Q

Grounds for imposition of a clinical hold include the following: ​

A) The investigator’s brochure is misleading ​

B) The investigator’s brochure is complete​

C) The IND does not contain sufficient info to assess risk ​

D) A and C

A

D) A and C

42
Q

Selecting qualified investigators.​

Providing investigators with the information they need to conduct the investigation.​

Ensuring proper monitoring of the trial.​

Ensuring the trial is conducted according to the plan and protocols contained in the IND.​

Informing the FDA and all investigators of significant new adverse effects or risks that are reasonably likely to be caused by the investigational new drug.​

Maintaining proper records.​

Disposing of unused supplies of the investigational new drug.

A

Sponsor responsibilities

43
Q

Sponsor Responsibilities

A

Selecting qualified investigators.​

Providing investigators with the information they need to conduct the investigation.​

Ensuring proper monitoring of the trial.​

Ensuring the trial is conducted according to the plan and protocols contained in the IND or IDE.​

Informing the FDA and all investigators of significant new adverse effects or risks that are reasonably likely to be caused by the investigational new drug.​

Maintaining proper records.​

Disposing of unused supplies of the investigational new drug.

44
Q

Can a sponsor transfer responsibilities to a CRO?

A

Yes, a sponsor can transfer all or some of their trial-related responsibilities to a Contract Research Organization (CRO). However, the sponsor is still ultimately responsible for the quality and integrity of the trial data.

45
Q

Investigators’ responsibilities include:​

A

Providing the sponsor with a completed, signed Statement of Investigator. (Form FDA 1572)​

Conducting the trial in accordance with the signed investigator statement, protocol, and applicable regulations.​

Protecting the rights, safety, and welfare of trial participants.​

Obtaining informed consent from all trial participants.​

Maintaining proper records.​

Furnishing all required progress reports, safety reports, financial disclosure reports, and a final report.​

Complying with Institutional Review Board review. and​

Ensuring the proper handling of controlled substances.

46
Q

The term “life – threatening” means:​

A) Diseases or conditions where the likelihood of death is high unless the course of disease is interrupted​

B) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival​

C) A and B​

D) None of the above

A

C) A and B​

47
Q

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:​

A) The FDA can validate the data from the study through an onsite inspection if the agency deems it necessary ​

B) The study was approved by the foreign agency ​

C) The study was conducted in accordance with good clinical practice (GCP)​

D) A and C ​

E) All of the above ​

A

D) A and C ​

47
Q

Will the FDA will accept as support for an IND or marketing approval, a well-designed and well-conducted foreign clinical study?

A

Yes

48
Q

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

7 days​

15 days​

30 days​

10 days

A

10 days

49
Q

Form 1572 is for what? and what must it contain?

A

Name and address of Clinical Investigation
name and code of protocol
name and address of research facility and any labs
name of address of responsible IRB
name of sub investigators
signed commitment by investigator

50
Q

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

A

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

51
Q

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

A) 7 calendar days for both​

B) 15 calendar days for both ​

C) 7 calendar days after first knowledge​

D) 15 calendar days after first knowledge​

E) A and B​

F) C and D

A

F) C and D

52
Q

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?​

5 working days​

7 working days​

5 calendar days​

7 calendar days

A

5 working days​

53
Q

For an IND, how soon should the sponsor report serious unexpected life-threatening safety events to FDA?​

7 calendar days.​

30 calendar days​

7 working days​

30 working days

A

7 calendar days.​

54
Q
A
55
Q

INDs that are “Inactive” for ___+ years may be terminated​

1​

3​

5​

7

A

5

56
Q

A sponsor that, on July 16, 1980, has an effective IND application for an investigation of a device shall continue to comply with the requirements of 21 CFR Part 312 until ____ days after that date.​
​
a) 30​
b) 60​
c) 90​
d) 120

A

c) 90​

SOCRA 2024 Flashcards (8 decks)

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