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Regulatory binder - PowerPoint PPT Presentation

Monday, November 7, 2016

Monday, November 7, 2016

REGULATORY “ESSENTIAL” DOCUMENTATION Role of the RESEARCH COORDINATOR Best Practices 21CFR Part 11. Monday, November 7, 2016. Disclosures: No conflicts of interest. The Presenter has no financial conflict of interest with any organization regarding the material discussed in this presentation.

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638 views • 62 slides
Monday, November 7, 2016

Monday, November 7, 2016

REGULATORY “ESSENTIAL” DOCUMENTATION Role of the RESEARCH COORDINATOR Best Practices 21CFR Part 11. Monday, November 7, 2016. Disclosures: No conflicts of interest. The Presenter has no financial conflict of interest with any organization regarding the material discussed in this presentation.

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806 views • 62 slides
Key Things to Know About Research

Key Things to Know About Research

Key Things to Know About Research. Presented by: Emmelyn Kim, MA, MPH, CPH Office of Research Compliance (ORC). ORC’s Mission. To provide comprehensive regulatory guidance to the research community to ensure the responsible conduct of research.

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494 views • 31 slides
Regulatory Binder: Maintaining Essential Study Documentation

Regulatory Binder: Maintaining Essential Study Documentation

Regulatory Binder: Maintaining Essential Study Documentation. Regulatory Binder. Based on ICH-GCP defined Essential Documents and OHRA’s Recordkeeping/Retention requirements ICH-GCP: International Conference on Harmonization – Good Clinical Practice Best Practice Standard

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259 views • 17 slides
Module H Interim Monitoring Visit

Module H Interim Monitoring Visit

Module H Interim Monitoring Visit. Denise Thwing 21 Apr 2010. Purpose Interim Monitoring Visit. Rights and well being of subjects are protected New information regarding drug is shared Verify site compliance with the protocol Confirm data points SDV Verify site regulatory adherence

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614 views • 12 slides

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