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SOCRA reporting timelines + etc. 2023 > SOCRA CCRP reporting timelines, etc. 2023 > Flashcards

SOCRA CCRP reporting timelines, etc. 2023 Flashcards

1
Q

What is the dollar threshold for reporting disclosures for equity interests? And what form would be submitted to disclose this information?

A

Any equity interest in any publicly held sponsor more than $50,000 in value. Form 3555.

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2
Q

What dollar amount is the threshold for reporting significant payments of other sorts from sponsor to investigator?

A

More than $25,000.

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3
Q

How long do sponsors have to keep financial disclosure records?

A

2 years after application approval and until 1 year post study completion.

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4
Q

What organization developed the Declaration of Helsinki?

A

The World Medical Association/WMA.

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5
Q

What basic ethical principles helped lead the development of OHRPs and IRBs?

A

The Belmont Report for conduct of biomedical and behavioral sciences research involving human subjects.

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6
Q

What are the 4 components that are required for an e-records system to be part 11 compliant?

A

System Validation, Audit Trails, unique e-signatures and copies available for download and monitoring.

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7
Q

If an IND or IDE is used in an emergency situation (including drug or in vitro device) to save a human life, how many days does Investigator have to report use to IRB?

A

5 working days.

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8
Q

When using the short form ICF, who signs what components?

A

Subject: short form only
Witness: short form and summary/original ICF both
Physician/obtainer: summary/original ICF only

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9
Q

Emergency use of a drug/medical device must be reported to the IRB within how many days?

A

5 working days.

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10
Q

What does IND stand for?

A

Investigational New Drug.

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11
Q

What does IDE stand for?

A

Investigational Device Exemption.

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12
Q

How often do IRBs need to renew registration?

A

3 years.

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13
Q

What is the minimum number of IRB members required?

A

5 members.

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14
Q

How long are IRBs expected to keep records for?

A

3 years after study completion.

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15
Q

What is another name for Expanded Access Use?

A

Compassionate use - is a way for patients to receive drug who is not eligible, but in a life-threatening situation and no other alternatives exist.

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16
Q

From time of FDA approval, how long are sponsors allowed to charge for Expanded Access Use to an IND?

A

1 year. Sponsor may request reauthorization for additional time after.

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17
Q

How many days does the sponsor have to report potential serious AEs through submission of IND safety report to the FDA and investigator/site?

A

15 calendar days.

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18
Q

Serious, unexpected ADRs/AEs that are not fatal or life threatening must be filed ASAP but no later than how many calendar days?

A

15 calendar days.

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19
Q

How many days from the day a sponsor discovers a serious suspected AE do they have to submit FDA Form 3500A?

A

15 calendar days

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20
Q

How many days does sponsor have to notify the FDA of unexpected fatal or life-threatening suspected adverse reactions for IDEs?

A

7 calendar days after first find out

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21
Q

If sponsor later determines an AE is reportable, how many days after new determination does sponsor have to report this to the FDA?

A

15 calendar days

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22
Q

A sponsor must provide an annual report within ___days of anniversary date the IND went into effect.

A

60 days

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23
Q

When is an IND Application approved?

A

30 days after submission to FDA or unless they approve earlier

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24
Q

How soon can a sponsor ship an investigational new drug to a site or investigator?

A

When IND application is approved, i.e. 30 days after submission to FDA or on earlier FDA authorization

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25
Q

FDA has how many days to respond to a sponsor request to lift a clinical hold?

A

30 calendar days after receipt

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26
Q

A study in a clinical hold is considered inactive after _____year(s).

A

1 year or more

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27
Q

After how many years of being inactive will an IND be terminated?

A

5+ years

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28
Q

After how many years of being in a clinical hold will a study be terminated?

A

5+ years (study in clinical hold after 1 year or more is considered inactive)

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29
Q

How many days does a sponsor have to respond to a FDA IND termination letter?

A

30 days

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30
Q

How many days does sponsor have to request a hearing in response to FDA’s letter of nonacceptance/IND termination?

A

10 days

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31
Q

When could a study be put in inactive status?

A

If a clinical study has not enrolled subjects in 2+ years or if an IND has been on a clinical hold for 1+ years.

32
Q

How many days does a Sponsor have to respond to the FDA if it is placed as inactive?

A

30 days

33
Q

If an IND remains inactive for _ years, it may be terminated.

A

5 or more years

34
Q

How long do investigators have to keep study files?

A

2 years after market approval or 2 years after study completion

35
Q

For how long does the Sponsor have to update and maintain financial disclosure information from investigators?

A

For at least 1 year after study completion

36
Q

For how long do investigator financial disclosures have to be maintained and updated?

A

During investigation and for 1 year after study completion

37
Q

How long does a sponsor have to report to the FDA, IRB and investigators if sponsors determine a study is discontinued due to unreasonable risk to subjects?

A

5 working days

38
Q

How long do sponsors have to keep complete and accurate study records?

A

2 years

39
Q

How long does a sponsor have to retain foreign clinical trials that are used to support an IND application?

A

2 years after marketing approval or 2 years after submission of IND application

40
Q

When is an Expanded Access Use IND approved?

A

30 days after submission to FDA or on earlier notification

41
Q

When is an Expanded Access Use Treatment Protocol approved?

A

30 days after submission to FDA or on earlier notification

42
Q

What is a significant risk device?

A

1. is intended as an implant

#2. is to be for use in supporting or sustaining human life
#3. is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise preventing impairment of human health, and
#4. Otherwise presents potential risk for serious risk to health, safety or welfare of subjects.

Examples include: cardiac pacemakers, hydrocephalus shunts

43
Q

For how long does the sponsor have to maintain records for studies done outside the US but are used to support an IDE application?

A

For 2 years after termination/completion of study or for 2 years after agency decision on a premarket approval application

44
Q

When is an IDE study allowed to begin?

A

30 days after FDA received the IDE application or earlier if FDA approves it earlier.

45
Q

When making IDE changes that do not impact validity, science or safety of subject, the sponsor does not need to get prior FDA approval but does need to submit a Notice of IDE change; when does a Notice of IDE Change submission need to be made by?

A

Sponsor must submit to FDA by 5 working days after making change

46
Q

When can a physician start treatment use of an investigational device?

A

30 days after IDE submission or upon earlier FDA approval

47
Q

For how long do sponsors of an IDE have to update investigator financial disclosure status?

A

For 1 year after study completion

48
Q

When must a sponsor terminate a study if it is determined that an unanticipated adverse device effect causes unreasonable risk to subjects?

A

Within 5 working days of determination, but no later than 15 working days after first notification of the unanticipated ADE.

49
Q

An investigator of an IDE must update sponsor of financial disclosure status and changes for how long?

A

1 year after study completion

50
Q

How long do investigators and sponsors have to maintain IDE study records for?

A

Either 2 years after study completion/termination or when 2 years from the date records are no longer needed to support a premarket approval application, etc., whichever is longest

51
Q

If Investigator withdraws responsibility of records custody and maintenance, how long does Investigator have to submit a Notice of a transfer?

A

10 working days after transfer occurs

52
Q

How many days does an investigator have to submit any unanticipated adverse device effects to Sponsor and IRB?

A

No later than 10 working days

53
Q

How many days does an Investigator have to report IRB withdrawal to the Sponsor?

A

5 working days

54
Q

What is the minimum number of Progress Reports an investigator must submit to Sponsor annually?

A

At least 1 per year

55
Q

Protocol deviations that occurred to protect patients (emergency use) must be submitted by Investigator to Sponsor and IRB within what time frame?

A

5 working days after deviation occurs

56
Q

If ICF is NOT collected prior to use, how many days does an investigator have to report this to the Sponsor?

A

5 working days after use occurs

57
Q

When is the Final Report Due from Investigator to Sponsor and IRB?

A

3 months after study completion or termination

58
Q

How many days does a Sponsor have to report investigations of unanticipated AEs to FDA?

A

Within 10 working days of when first learns of it from investigator

59
Q

How many days does a Sponsor have to report withdrawal of IRB approval of an investigation/part of an investigation to the FDA?

A

5 working days after receipt

60
Q

How many days does a Sponsor have to notify IRB and investigators of any FDA approval withdrawals?

A

5 working days of receipt of notice

61
Q

How often does a Sponsor have to submit current lists of investigators to the FDA?

A

Every 6 months

62
Q

What is the minimum a Sponsor must submit Progress Reports to the FDA of a Significant Risk device study?

A

Semi-annually

63
Q

What is the reporting timeline for device recalls/disposals by Sponsor to FDA and IRB?

A

30 working days

64
Q

For Significant Risk Devices, when must the Sponsor submit a Final Report to FDA?

A

Notification within 30 days of study completion to FDA; Final Report must be submitted to the FDA and IRB within 6 months after study completion or termination

65
Q

For Non-Significant Risk Devices, when must the Sponsor submit a Final Report to FDA and IRB?

A

6 months after study completion or termination

66
Q

If an investigator uses a device prior to collecting Informed Consent, how many days do they have to report to the Sponsor? What about Sponsor reporting to FDA?

A

Within 5 working days of notice of use by investigator; within 5 working days of when sponsor first notified

67
Q

If IRB determines an application is a significant risk device after initial submission of a non-significant risk device, how many days does the Sponsor have to notify the FDA of this determination?

A

Within 5 working days of first learning of it

68
Q

Per 45 CFR part 46, how often should the FDA and other agencies re-examine the meaning of “identifiable private information?”

A

Within 1 year of organization implementation and at least every 4 years/regularly

69
Q

How long do IRBs have to keep and maintain study records?

A

3 years after study completion

70
Q

For studies supported by Federal agencies and funding, when must the CT’s ICF be publicly posted and available by? (i.e. clinicaltrials.gov, etc.)

A

After clinical trial is closed to recruitment, and no later than 60 days after last study visit by any subject

71
Q

How long is an IRB effective for after initial registration acceptance?

A

3 years

72
Q

How often does IRB have to renew it’s registration?

A

Every 3 years

73
Q

If the IRB Chairperson or contact person changes, when do these changes need to be submitted?

A

Submission of change to OHRP must be made within 90 days after change occurs.

74
Q

How long does an IRB have to report OHRP of an IRB disbandment?

A

Decision to disband must be submitted to OHRP within 30 days of permanent cessation

75
Q

Unexpected serious suspected adverse reactions must be reported by Sponsor to FDA within how many days?

A

15 calendar days from first notice

76
Q

Unexpected fatal or life-threatening suspected adverse reactions must be reported to FDA ______, but no later than ____calendar days after sponsor first hears of it.

A

ASAP; 7 calendar days

77
Q

Any additional follow-up reporting after initial safety report submission should be submitted by Sponsor to FDA within how many calendar days?

A

15 calendar days

SOCRA reporting timelines + etc. 2023 (1 decks)

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