when must the investigator update the irb ?

Description

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/investigator-responsibilities/index.html

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/investigator-responsibilities/index.html
Investigator Responsibilities FAQs | HHS.gov
The HHS regulations at 45 CFR part 46 use the term investigator to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions
Institutional Review Boards Frequently Asked Questions | FDA
1. What is an Institutional Review Board (IRB)? Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research…

https://www.wcgclinical.com / insights / changes-in-research-what-are-they-and-when-do-they-need-to-be-submitted-to-the-irb

https://www.wcgclinical.com / insights / changes-in-research-what-are-they-and-when-do-they-need-to-be-submitted-to-the-irb
Changes in Research: What are They and When do They Need to be … – WCG
All changes in research must be reviewed and approved by the IRB before implementing the proposed modification, unless the change is designed to eliminate an apparent immediate hazard to subjects (45 CFR 46.103 (b) (4)).

https://slickspring.com/irb-requirements-and-guidelines/when-must-the-investigator-update-the-irb-about-the-progress-of-a-trial

https://slickspring.com/irb-requirements-and-guidelines/when-must-the-investigator-update-the-irb-about-the-progress-of-a-trial
When Must The Investigator Update The Irb About The Progress Of A Trial …
The investigator should provide updates every three to six months and should provide a final report within three months of the completion of the trial. The updates and the final report should include all relevant data, any changes to the protocol, and the final results.

https://irb.wisc.edu/manual/investigator-manual/appendix-a-additional-research-requirements/fda-regulated-research

https://irb.wisc.edu/manual/investigator-manual/appendix-a-additional-research-requirements/fda-regulated-research
FDA-Regulated Research – Institutional Review Board
An investigator must assure that an IRB that complies with the requirements set forth in 21 CFR §56 will be responsible for the initial and continuing review and approval of the proposed clinical study. … The investigator must promptly update this information if any relevant changes occur during the course of the investigation and for 1 year …

https://www.fda.gov/media/78830/download

https://www.fda.gov/media/78830/download
Information Sheet Guidance for Sponsors, Clinical Investigators, and
10. Must investigators who conduct studies outside of the United States sign a … 30. Does the IRB reviewing and approving the clinical study have to be at

https://www.fda.gov/media/83121/download

https://www.fda.gov/media/83121/download
Guidance for IRBs, Clinical Investigators, and Sponsors
An IRB must review previously approved research at least once a year (21 CFR 56.109(f)). Review must be conducted at convened meetings at which a majority of the IRB

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.64

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.64
CFR – Code of Federal Regulations Title 21 – Food and Drug Administration
17 oct. 2023The investigator must record nonserious adverse events and report them to the sponsor according to the timetable for reporting specified in the protocol. (c) … The clinical investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/institutional-issues/institutional-review-board-written-procedures/index.html

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/institutional-issues/institutional-review-board-written-procedures/index.html
Institutional Review Board Written Procedures: Guidance for …
I. IRB Initial and Continuing Review of Research; Reporting IRB Findings and Actions: REGULATORY REQUIREMENT – Each IRB must follow written procedures for conducting initial and continuing review of research and for reporting IRB findings and actions to the investigator and the institution [45 CFR 46.103(b)(4)(i), 21 CFR 56.108(a)(1)]

https://www.fda.gov/files/about fda/published/IRB-Responsibilities-for-Reviewing-the-Qualifications-of-Investigators–Adequacy-of-Research-Sites–and-the-Determination-of-Whether-an-IND-IDE-is-Needed-(Printer-Friendly).pdf

https://www.fda.gov/files/about fda/published/IRB-Responsibilities-for-Reviewing-the-Qualifications-of-Investigators–Adequacy-of-Research-Sites–and-the-Determination-of-Whether-an-IND-IDE-is-Needed-(Printer-Friendly).pdf
PDF Guidance for IRBs, Clinical Investigators, and Sponsors
Must an IRB review the qualifications of clinical investigators who conduct FDA- … 6 See 21 CFR 56.102(g), (h), and (j) for definitions of IRB, investigator, and sponsor, … lesoutrali bot