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Socra Study > 21 CFR Part 312 > Flashcards

21 CFR Part 312 Flashcards

1
Q

What does 21 CFR 312 apply to?

A

Clinical investigations of products (Investigational New Drugs)

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2
Q

What conditions must be met under 21 CFR 312 for exemption?

A

-not for new use or new indication of labeling
-not for change in advertising of prescription drug
-does not change risk associated with study drug by changing route/dosing/use
-investigation meets all other requirements

MUST MEET ALL OF THESE

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3
Q

How should an investigational new drug be labelled?

A
  • Must bear a label saying “Caution: New Drug—Limited by Federal (or United States) law to investigational use.”
    -cannot be false or misleading
    -cannot claim the product is safe or effective
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4
Q

Can an IND be commercially distributed?

A

No

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5
Q

Can an IND be promoted?

A

No, a sponsor or investigator cannot say it is safe or effective for what it is being investigated for.

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6
Q

Can a sponsor prolong an investigation after finding that the results of the investigation establish sufficient data to support a marking application?

A

No

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7
Q

General criteria for charging for investigational new drugs

A

1) sponsor must meet requirements
2) sponsor must justify amount to be charged
3) sponsor must get prior FDA authorization to charge
4) FDA will withdraw authorization to charge if charging is interfering with development of drug

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8
Q

What must a sponsor do to charge for a drug?

A

1) Provide evidence the drug has potential benefit that would outperform available products
2) Demonstrate that data from the trial could establish that the drug is effective or safe or would support a labeling change
3) Demonstrate that they have to charge since the cost of the drug is extraordinary to the sponsor

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9
Q

How long can a sponsor charge for a drug?

A

The duration of the trial unless the FDA specifies a shorter period

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10
Q

When should the FDA provide a written determination for an IND(Form FDA 1571)?

A

30 days or earlier

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11
Q

What needs to be submitted to the FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug?

A

IND

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12
Q

Phase 1 trials

A

-initial introduction of investigational new drug to humans
-tests metabolism, side effects, may gain early evidence
-closely monitored
-20 to 80 people

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13
Q

Who might be in a Phase 1 trial?

A

Normal healthy volunteers, unless drugs could be toxic (like cancer drugs), in which case patients with end-stage disease

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14
Q

Phase 2 trials

A

-evaluate effectiveness for a particular indication, determine common side effects
-closely monitored
-several hundred subjects
-Drug being studied is often compared to a placebo or different drug

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15
Q

Phase 3 trials

A

-after there is evidence the drug is effective
-gather more info about effectiveness and safety
-evaluate benefit-risk relationship of the drug
-provides basis for drug labeling
-several hundred to several thousand people

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16
Q

Phase 4 trials

A

Post approval, can look at long-term safety or compare the drug to other drugs on the market. Could be required by the FDA is the drug is approved through an accelerated process.

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17
Q

What happens at the end of a Phase 2 trial?

A

FDA and sponsors discuss how large-scale studies in Phase 3 will be done.

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18
Q

Difference between how the FDA evaluates phase 1 trials vs phases 2 and 3

A

FDA looks for subject safety and rights in phase 1, but is more concerned with scientific quality of the investigation in phases 2 and 3.

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19
Q

What should an Investigational New Drug application (IND) contain? 10 points

A

1) Cover sheet
2) Table of Contents
3) Intro statement and investigational plan
4) Investigator’s brochure
5) Protocols
6) Chemistry, manufacturing, and control information
7) Pharmacology and toxicology information
8) Previous human experience with the investigational drug
9) Additional Information
10) Information previously submitted

also needs FDA Forms 1571 and 1572

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20
Q

Cover sheet for an IND should include

A

1) Name and address of the SPONSOR, date, name of drug
2) Phase of trial
3) Commitment to not start until IND is in effect
4) Commitment to comply with IRB, give them initial and continuing reviews
5) commitment to follow regulatory requirements
6) name and title of monitor
7) name and title of person responsible for review and evaluation of drug safety
8) name and address of CRO’s and obligations transferred (if applicable)
9) sponsor signature

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21
Q

Introductory statement should include

A

1) name of drug, structure, ingredients, dosage, broad objectives and duration of clinical trial
2) other human experience with drug
3) if the drug has been withdrawn from other markets
4) plan for investigating study drug

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22
Q

Investigator’s brochure should include

A

1) description of drug and formulation
2) summary of drug effects
3) summary of how body interacts with drug
4) info on safety and effectiveness
5) possible risks, side effects, precautions

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23
Q

Difference between phase 1 and 2/3 protocols

A

Phase 1 is an outline, only needs detail in parts that are critical to safety. Phase 2/3 needs detail in all areas.

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24
Q

Protocol for an IND should include

A

1) statement of objectives and purpose of the study
2) Name/address/qualifications of the investigators, research facilities, IRB
3) inclusion/exclusion criteria and number of subjects
4) design of study
5) method of determining dose, maximum dose, duration of participant exposure to drug
6) observations and measurements that will be made
7) clinical procedures, lab tests, other measures taken to minimize risk

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25
Q

Special topics that may require additional information in an IND may include

A

1) drug dependence and abuse potential
2) radioactive drugs
3) pediatric studies
4) any other relevant info that would help evaluate

26
Q

Does a sponsor need to resubmit information previously submitted for an IND?

A

No, but they should reference it

27
Q

What should the sponsor submit with their IND if they have material in a foreign language?

A

The original literature and an accurate and complete English translation

28
Q

How many copies need to go in an IND file?

A

3, the original and 2 copies

29
Q

How should an IND number its submissions?

A

Initial IND should be numbered 000, each subsequent submission should be numbered chronologically in sequence

30
Q

What needs to be submitted if a sponsor wants to conduct a new study under an IND?

A

The sponsor should submit a protocol amendment with the new protocol in place. Must be submitted to FDA and be approved by the IRB

31
Q

Should a sponsor submit a separate IND when conducting an investigation with an exception from informed consent for emergency research?

A

Yes

32
Q

When should a sponsor submit a separate IND?

A

When conducting an investigation with an exception from informed consent for emergency research

33
Q

Examples of changes requiring an amendment under an IND

A

1) increase in drug dosage or duration of exposure
2) significant increase in number of participants
3) significant change in design of protocol
4) adding a new test to monitor safety or reduce side effect risk
5) dropping a test that monitored safety

34
Q

What sort of information might require an information amendment?

A

-new toxicology, chemical, or other technical info
-report regarding the discontinuance of a clinical investigation

35
Q

What goes in an information amendment (what makes it different from other amendments?)

A

essential info that wouldn’t go in a protocol amendment, IND safety reports, or an annual report

content includes:
1) statement of nature and purpose of the amendment
2) organized submission of the data
3) request for FDA to comment if desired by sponsor

36
Q

How often should information amendments to the IND be submitted?

A

As necessary, but not more than once every 30 days

37
Q

When should an IND safety report be submitted to the FDA?

A

1) serious and unexpected suspected adverse reaction
2) findings from other studies that suggest significant risk
3) findings from animal or in vitro testing
4) increase in occurrence in serious suspected adverse reactions
5)

38
Q

How quickly should an IND safety report be submitted to the FDA?

A

ASAP, no later than 15 days

39
Q

When does additional information requested by the FDA for an IND safety report need to be submitted?

A

ASAP, no later than 15 days

40
Q

When does the sponsor need to notify the FDA of an unexpected fatal or life threatening suspected adverse reaction by?

A

ASAP, no later than 7 calendar days

41
Q

How should relevant follow-up information to an IND safety report be submitted?

A

As soon as possible, and should be clearly marked as a Follow-up IND Safety Report

42
Q

Is a safety report an admission that the study drug caused or contributed to an AE?

A

No

43
Q

When should an annual report be submitted for an IND?

A

Within 60 days of the anniversary date the IND went into effect

44
Q

What should an annual report for an IND include?

A

1) individual study info (name, number of subjects planned, study results)
2) summary info (SAEs, IND safety reports, deaths, info gained)
3) investigational plan for the coming year
4) if investigator’s brochure has changed, description of revision and new brochure
5) any Phase 1 protocol mods made and not already submitted
6) significant foreign marketing developments
7) outstanding business for the IND (if sponsor requests)

45
Q

When may a sponsor withdraw an IND?

A

At any time

46
Q

What is FDA form 1571?

A

an IND application

47
Q

What FDA form is an IND application?

A

FDA Form 1571

48
Q

What is FDA form 1572?

A

(Statement of Investigator) the document that notifies FDA of relevant changes in investigators conducting clinical trials under the IND

should be submitted with FDA form 1571 (IND application)

49
Q

Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?

A

Phase I

50
Q

What does a sponsor/ sponsor-investigator agree to when signing Form FDA 1571?

A

-Not to begin clinical investigations until 30 days after FDA’s receipt of the IND, unless the investigator receives earlier notification from the FDA
-Not to begin or continue investigations covered by the IND if those studies are placed on clinical hold
-That an IRB/IEC that complies with 21 CFR 56 will be responsible for initial and continuing review and approval of each of the studies in the proposed clinical investigations
-To conduct the investigation in accordance with all other applicable regulatory requirements

51
Q

Once an IND is submitted and becomes effective, a sponsor-investigator who is an IND holder is required to submit reports/updates to whom?

A

The FDA

52
Q

What are the 3 types of protocol amendments?

A

-New sponsor protocol
-A change in an existing protocol when the entire sponsor protocol is not revised
-Identifying and adding a new investigator to a study

53
Q

When should an information amendment be submitted?

A

Information amendments must be submitted when new toxicology, chemistry or other technical information is available. The IND holder must also report study discontinuation to the FDA as an information amendment.

54
Q

Who must an IND report (Annual report) be submitted to?

A

Investigators must submit annual reports (also referred to as IND reports) to the sponsor-investigator and the sponsor-investigator must submit annual reports to the FDA within 60 days of the anniversary date that the IND went into effect.

55
Q

Who is a final report submitted to?

A

Investigators must provide the sponsor with an adequate report shortly after completion of the investigator’s participation in the investigation.

56
Q

What form must be filled out by the sponsor before an investigational new drug can be shipped to an investigator?

A

Form FDA 1571(aka IND application) or an Investigational Device Exemption (IDE)

57
Q

What form does FDA required information about the investigator and subinvestigator go on when researching investigational drugs?

A

Form FDA 1572(statement of investigator)

58
Q

What form does FDA required information about the investigator and subinvestigator go on when researching investigational devices?

A

This information is usually included in the investigator’s agreement

59
Q

What does the investigator agree to in Form FDA 1572?

A

-Personally conduct or supervise the investigation according to the protocol.
-Inform the subjects that the drugs are being used for investigational purposes and satisfy other requirements for obtaining informed consent.
-Maintain complete and accurate records and make the records available for inspection.

60
Q

Under 21 CFR 312, who can administer the investigational drug?

A

An investigator shall administer the drug only to subjects under the investigator’s personal supervision or under the supervision of a sub-investigator responsible to the investigator.

61
Q

Can the investigator delegate responsibility for product accountability?

A

Yes, but they remain ultimately responsible.

62
Q

Who do US regulations require to monitor the conduct of a clinical study under and IND or IDE?

A

The Sponsor

Socra Study (14 decks)

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