Title:	Chapter 14 - FDA Regulated Research
Author:	Swan, Jeremy (NIH/NICHD) [C]	Jan 10, 2023
Last Changed by:	Pauly, Kelly (NIH/OD) [E]	Mar 26, 2024
Tiny Link: (useful for email)	https://irbo.nih.gov/confluence/x/sQCyBw
Export As:	Word · PDF

Office of Human Subjects Research Protections (2)     Page: Chapter 13 - Conducting Research with Special Populations     Page: chapter 14 Flowchart

Parent Page     Page: Investigator Manual

Children (1)     Page: chapter 14 Flowchart

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Time	Editor
Mar 26, 2024 11:35	Pauly, Kelly (NIH/OD) [E]	View Changes
Mar 20, 2024 10:37	Pauly, Kelly (NIH/OD) [E]	View Changes
Mar 29, 2023 16:22	Swan, Jeremy (NIH/NICHD) [C]	View Changes
Mar 29, 2023 16:22	Swan, Jeremy (NIH/NICHD) [C]	View Changes
Mar 27, 2023 12:47	Sanders, Margaret (NIH/OD) [E]

External Links (41)
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    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-…
    https://www.ecfr.gov/current/title-21/section-312.59
    https://www.fda.gov/medical-devices/investigational-device-…
    https://www.fda.gov/media/71816/download
    https://irbo.nih.gov/confluence/display/ohsrp/Chapter%2014%…
    https://www.ecfr.gov/current/title-21/section-809.10
    https://www.fda.gov/media/75459/download
    https://www.fda.gov/media/79386/download
    https://www.fda.gov/drugs/investigational-new-drug-ind-appl…
    https://www.fda.gov/medical-devices/investigational-device-…
    https://www.ecfr.gov/cgi-bin/text-idx?SID=ea0b043fcd4359d75…
    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-…
    https://policymanual.nih.gov/3014-801
    https://www.fda.gov/media/72267/download
    https://policymanual.nih.gov/3014-501
    https://policymanual.nih.gov/3014-502
    https://policymanual.nih.gov/3014-500
    https://www.fda.gov/medical-devices/investigational-device-…
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    https://www.fda.gov/vaccines-blood-biologics/development-ap…
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    https://www.fda.gov/drugs/investigational-new-drug-ind-appl…
    https://www.fda.gov/media/78830/download
    https://www.fda.gov/medical-devices/investigational-device-…
    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-…
    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-…
    https://www.ecfr.gov/current/title-21/section-812.2
    https://www.fda.gov/medical-devices/investigational-device-…
    https://www.fda.gov/media/75381/download
    https://www.fda.gov/news-events/expanded-access/expanded-ac…
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    https://www.fda.gov/medical-devices/investigational-device-…
    https://www.ecfr.gov/current/title-21/part-812
    https://www.fda.gov/drugs/investigational-new-drug-ind-appl…
    https://irbo.nih.gov/confluence/pages/viewpage.action?pageI…
    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-…
    https://policymanual.nih.gov/1743

Office of Human Subjects Research Protections (3)     Page: Chapter 14 - FDA Regulated Research     Page: chapter 14 Flowchart     Page: Chapter 15 - International Research