Updates effective as of January 31, 2025

Summary of Policy Updates Review Recordings and Slides from Office Hours Webinars DF/HCC Guidance & FAQ: CON-101 Requriement for Long Form Translation Following Use of a Short Form

Updates effective as of August 1, 2023

Summary of Policy Updates
Educational Office Hours Webinar - New Policy RCO-104 Slides - Educational Office Hours - New Policy RCO-104

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Updates effective as of May 31, 2023

Summary of Policy Updates

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Updates effective as of March 14, 2023

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Updates effective as of January 3, 2023

Summary of Policy Updates

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Updates effective as of September 30, 2022

Summary of Policy Updates

Updates effective as of February 28, 2022

Summary of Policy Updates Note-to-File: Early Implementation of RCO-204 Version 12 UPDATED - FAQ: DF/HCC Policy on Review and Receipt of IND Safety Reports NEW - 9-minute e-Learning on "Investigator Review of External IND Safety Reports"

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Updates effective as of September 1, 2021

Review a Summary of Policy Updates

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Updates effective as of February 1, 2021

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Updates effective as of October 1, 2020

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Updates effective as of June 30, 2020

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Updates effective as of April 27, 2020

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Updates effective as of January 31, 2020

Click here to view a summary of the January 31, 2020 policy updates Click here for a January 2020 Policy Update Training Record Click here for a Guidance/FAQ - 1572 Requirement Change Watch eLearning on 1572 Change & Policy Updates (~12 min)