How long do you have to respond to FDA post-submission?
30 Days
Document retention of trial reports for internationally conducted studies being used for IDE app in the US
2 years post-IDE termination/completion
How long do you have to retain documents for an internation trial documents being used to support apps other than IDE (marketing, product development protocol)?
2 years post-FDA decision on said submission
Changes to protocol/PDs d/t emergency use
5 working days post-sponsor awareness
activation of Tx IDE apps
30 days post-FDA receipt
Maintenance/update of PI financial disclosure
1 year post-study closure
termination d/t unanticipated AE posing sig. risk
“*max of 5 days post-decision
*max 15 days post-sponsor first made aware”
general document retention
“2 years after the latter of the following dates:
-study termination/completion
-records no longer needed for any type of marketing app”
FDA alert that sponsor has asked 3rd part to handle document retention
max of 10 working days post-transfer
PI to Sponsor: Unexpected AEs
max 10 working days post-awareness
PI to Sponsor: IRB withdraw
max 5 working days
PI to Sponsor: PDs resulting in emergencies
max 5 working days
PI to Sponsor: ICF not obtained before emergency use
max 5 working days
PI to Sponsor: submission of final report
3 months post-termination/completion
Sponsor to FDA: unexpected AEs
10 working days post-first made aware
Sponsor to FDA: IRB withdrawal
5 working days post-notice
Sponsor to FDA: PI/Sub-I list
6 months post-1st approval
Sponsor to FDA: Significant Risk classification by IRB
5 days post-notice
Sponsor to IRB: FDA withdrawal
5 working days post-notice
Sponsor to FDA/IRB: PI request to return/fix/dispose of device
w/in 30 days of request
Sponsor to FDA/IRB: submission of final report
max of 30 days post-study closure
Sponsor to FDA/IRB: ICF not obtained before emergency use
max of 5 days post-being made aware by PI
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The Nuremberg Code17
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The Belmont Report24
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The Declaration of Helsinki7
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ICH Harmonized Guideline for Good Clinical Practice, E6(R3)24
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21 CFR Part 111
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IND Reporting Timelines27
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IDE Reporting Timelines22
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Practice Questions23
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Part 46, Industry GCP, and ICH Reporting Timelines16
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Study Guide171
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Regulatory Guide75
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General Knowledge51
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Practice Test107
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Informed Consent15
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FDA Forms8
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Title 21 Definitions16
