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SOCRA > TIMELINES > Flashcards

TIMELINES Flashcards

1
Q

An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than _________

A

Once per year

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2
Q

The Secretary of the Department of Health & Human Services (HHS) has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary will evaluate the list at least every __ _____ and amend as appropriate.

A

8 years

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3
Q

IRB records shall be retained for at least __ ______ after completion of the research

A

3 years

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4
Q

If obtaining informed consent is not feasible (due to life threatening situation, inability to communicate with subject or obtain legally effective consent, time is not sufficient to obtain consent from the subject’s legal representative, and there is no available alternative method of approved/generally recognized therapy), documentation by investigator shall be submitted to IRB within __ _____ after use of the test article

A

5 days

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5
Q

Emergency use of a test article is reported to the IRB/FDA within __ ______

A

5 days

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6
Q

Each IRB must renew its registration every __ ______

A

3 years

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7
Q

If an IRB’s contact or chair person information changes, the IRB must revise its registration information by submitting any changes in that information within __ _____ of the change

A

90 days

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8
Q

An IRB’s decision to review new types of FDA-regulated products or to discontinue reviewing clinical investigations regulated by FDA is a change that must be reported within __ ______ of the change

A

30 days

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9
Q

An IRB’s decision to disband is a change that must be reported within __ _____ of permanent cessation of the IRB’s review of research.

A

30 days

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10
Q

Charging for expanded access to an investigational drug for treatment use may continue for __ _____ from the time of FDA authorization

A

1 year

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11
Q

FDA shall provide a written determination for an IND __ _____ after FDA receives the IND or earlier

A

30 days

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12
Q

Phase 1 studies - total number of subjects

A

20 - 80

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13
Q

Phase 2 studies - total number of subjects

A

Several hundred

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14
Q

Phase 3 studies - total number of subjects

A

Several hundred to several thousand

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15
Q

The sponsor shall submit a protocol amendment when a new investigator is added to an IND and notify FDA within __ _____ of the investigator being added

A

30 days

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16
Q

A protocol change intended to eliminate an apparent immediate hazard to subjects may be implemented _______ provided FDA is subsequently notified by protocol amendment and then reviewing IRB is notified

A

Immediately

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17
Q

Information amendments (new chemistry information, removing investigator) to the IND should be submitted not more than every __ _____

A

30 days

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18
Q

The sponsor must notify FDA and all participating investigators in an IND safety report of potential serious risks, from clinical trials or any other source, as soon as possible, but in no case later than __ ______ after the sponsor determines that the information qualifies for reporting

A

15 days

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19
Q

The sponsor must notify FDA of any unexpected fatal or life-threatening suspected adverse reactions as soon as possible but in no case later than __ ____ after the sponsor’s initial receipt of the information

A

7 days

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20
Q

If the results of a sponsor’s investigation show that an adverse event not initially determined to be reportable is actually reportable, the sponsor must report such suspected adverse reaction in an IND safety report as soon as possible, but in no case later than __ _____ after the determination is made

A

15 days

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21
Q

A sponsor shall within __ ______ of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation

A

60 days

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22
Q

An IND goes into effect __ _____ after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold

A

30 days

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23
Q

A sponsor may ship an investigational new drug to investigators named in the IND __ ____ after FDA receives the IND

A

30 days

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24
Q

If all investigations covered by an IND remain on clinical hold for __ _____ or more, the IND may be placed on inactive status by FDA

A

1 year

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25
Q

FDA may propose to terminate an IND if it finds that the IND has remained on inactive status for __ _____ or more

A

5 years

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26
Q

If FDA proposes to terminate an IND, FDA will notify the sponsor in writing, and invite correction or explanation within a period of __ _____

A

30 days

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27
Q

The sponsor’s request for a regulatory hearing must be made within __ _____ of the sponsor’s receipt of FDA’s notification of nonacceptance

A

10 days

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28
Q

If no subjects are entered into clinical studies for a period of __ _____ or more under an IND, or if all investigations under an IND remain on clinical hold for __ _____ or more, the IND may be placed by FDA on inactive status

A

2 years

1 year

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29
Q

Upon receipt of notification by the FDA, the sponsor shall have __ ____ to respond as to why the IND should continue to remain active

A

30 days

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30
Q

A sponsor who determines that its investigational drug presents an unreasonable and significant risk to subjects shall discontinue those investigations that present the risk, notify FDA, all IRBs, and all investigators. The sponsor shall discontinue the investigation as soon as possible, and in no event later than __ _____ after making the determination that the investigation should be discontinued

A

5 days

31
Q

A sponsor shall retain all records and reports for __ _____ after a marketing application is approved for the drug or if an application is not approved, until __ ____ after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified

A

2 years

2 years

32
Q

An investigator shall retain all records and reports for __ ____ following the date a marketing application is approved for the drug or if no application is to be filed or if the application is not approved, until __ ____ after the investigation is discontinued and FDA is notified

A

2 years

2 years

33
Q

The investigator shall promptly update financial disclosure information to the sponsor if any relevant changes occur during the course of the investigation and for __ _____ following the completion of the study

A

1 year

34
Q

IDE changes (developmental changes, changes to clinical protocol, changes from credible information) may be made without prior FDA approval if the sponsor submits a notice of the change to the IDE not later than __ _____ after making the change

A

5 days

35
Q

Treatment IDE’s may begin __ _____ after FDA receives the treatment IDE submission

A

30 days

36
Q

A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects shall terminate all investigations as soon as possible. Termination shall occur not later than __ ____ after the sponsor makes this determination and not later than __ ____ after the sponsor first received notice of the effect

A

5 days

15 days

37
Q

An investigator or sponsor may withdraw from the responsibility to maintain records and transfer custody of the records to any other person. Notice of a transfer shall be given to FDA not later than __ _____ after the transfer occurs

A

10 days

38
Q

An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than __ ____ after the investigator first learns of the effect

A

10 days

39
Q

An investigator shall report to the sponsor, within __ _____, a withdrawal of approval by the reviewing IRB of the investigator’s part of an investigation

A

5 days

40
Q

An investigator shall submit progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less often than __

A

Yearly

41
Q

An investigator shall notify the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in no event later than __ ____ after the emergency occurred

A

5 days

42
Q

If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within __ ____ after the use occurs

A

5 days

43
Q

An investigator shall, within __ _____ after termination or completion of the investigation or the investigator’s part of the investigation, submit a final report to the sponsor and the reviewing IRB

A

3 months

44
Q

A sponsor who conducts an evaluation of an unanticipated adverse device effect shall report the results of such evaluation to FDA and to all reviewing IRB’s and participating investigators within __ _____ after the sponsor first receives notice of the effect

A

10 days

45
Q

A sponsor shall notify FDA and all reviewing IRB’s and participating investigators of any withdrawal of approval of an investigation by a reviewing IRB within __ _____ after receipt of the withdrawal of approval

A

5 days

46
Q

A sponsor shall notify all reviewing IRB’s and participating investigators of any withdrawal of FDA approval of the investigation and shall do so within __ ____ after receipt of notice of the withdrawal of approval

A

5 days

47
Q

A sponsor shall submit to FDA, at __ _____ intervals, a current list of the names and addresses of all investigators participating in the investigation. The sponsor shall submit the first such list __ ____ after FDA approval

A

6 month

6 month

48
Q

At regular intervals, and at least ____, a sponsor shall submit progress reports to all reviewing IRB’s. In the case of a significant risk device, a sponsor shall also submit progress reports to FDA.

A

Yearly

49
Q

A sponsor shall notify FDA and all reviewing IRB’s of any request that an investigator return, repair, or otherwise dispose of any units of a device. Such notice shall occur within __ ____ after the request is made and shall state why the request was made

A

30 days

50
Q

In the case of a significant risk device, the sponsor shall notify FDA within __ ____ of the completion or termination of the investigation and shall submit a final report to FDA and all reviewing IRB’s and participating investigators within __ _____ after completion or termination

A

30 days

6 months

51
Q

In the case of a device that is not a significant risk device, the sponsor shall submit a final report to all reviewing IRB’s within __ ____ after termination or completion

A

6 months

52
Q

A sponsor shall submit to FDA a copy of any report by an investigator of use of a device without obtaining informed consent, within __ _____ of receipt of notice of such use

A

5 days

53
Q

If an IRB determines that a device is a significant risk device, and the sponsor had proposed that the IRB consider the device not to be a significant risk device, the sponsor shall submit to FDA a report of the IRB’s determination within __ _____ after the sponsor first learns of the IRB’s determination

A

5 days

54
Q

An active protocol is any protocol for which the IRB conducted an initial review or a continuing review at a convened meeting or under an expedited review procedure during the preceding __ _______

A

12 months

55
Q

IRB registration is effective for __ ______

A

3 years

56
Q

The sponsor for an Applicable Clinical Trial (ACT) must submit and register the required clinical trial information to clinicaltrials.gov no later than __ _____ after enrollment of the first participant

A

21 days

57
Q

Results information for an Applicable Clinical Trial (ACT) subject to the results information submission requirements must be submitted to clinicaltrials.gov by the sponsor no later than __ ______ after the primary completion date

A

1 year

58
Q

The Director will post publicly on clinicaltrials.gov the clinical trial registration information, except for certain administrative data, for an applicable drug clinical trial not later than __ _____ after the sponsor has submitted such information

A

30 days

59
Q

The Director will post publicly clinical trial results information on clinicaltrials.gov no later than __ ____ after the date of submission of clinical trial results

A

30 days

60
Q

Changes to the clinical trial registration information must be updated every __ _____ on clinicaltrials.gov

A

12 months

61
Q

Overall recruitment status on clinicaltrials.gov must be updated not later than __ _____ after any change in overall recruitment status

A

30 days

62
Q

Primary Completion Date must be updated on clinicaltrials.gov not later than __ _____ after the clinical trial reaches its actual primary completion date

A

30 days

63
Q

If the first human subject was not enrolled in the clinical trial at the time of registration, the Study Start Date must be updated on clinicaltrials.gov not later than __ _____ after the first human subject is enrolled

A

30 days

64
Q

Intervention name must be updated on clinicaltrials.gov to a non-proprietary name not later than __ _____ after a non-proprietary name is established for any intervention included in the intervention name data element

A

30 days

65
Q

Expanded Access Status must be updated on clinicaltrials.gov not later than __ _____ after a change in the availability of expanded access to an investigational drug product

A

30 days

66
Q

Overall recruitment status must be updated on clinicaltrials.gov not later than __ ____ after any change in overall recruitment status (i.e. changed to suspended, terminated, withdrawn, etc)

A

30 days

67
Q

Individual site status must be updated on clinicaltrials.gov not later than __ _____ after a change in status for any individual site

A

30 days

68
Q

Study completion date must be updated on clinicaltrials.gov not later than __ _____ after the clinical trial reaches its actual study completion date

A

30 days

69
Q

Device product not approved or cleared by US FDA must be updated on clinicaltrials.gov not later than __ _____ after a change in approval or clearance status has occurred

A

15 days***

70
Q

Record verification date must be updated on clinicaltrials.gov any time the sponsor reviews the complete set of submitted clinical trial information for accuracy and not less than every __ ______ even if no other updated information is submitted at that time

A

12 months

71
Q

If a protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial, updates to any relevant clinical trial registration information data elements must be submitted on clinicaltrials.gov not later than __ _____ after the protocol amendment is approved by a human subjects protection review board

A

30 days

72
Q

Fatal or life-threatening unexpected adverse drug reactions occurring in clinical investigations should be reported to regulatory agencies no later than __ _____ after first knowledge by the sponsor, followed by as complete a report as possible within an additional __ ______

A

7 days

8 days

73
Q

Serious unexpected adverse drug reactions that are not fatal or life-threatening must be filed no later than __ _____ after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting

A

15 days

74
Q

The Investigator’s Brochure should be reviewed at least _______ and revised as necessary in compliance with a sponsor’s written procedures

A

Annually

SOCRA (2 decks)

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