From 5cd1bf080450b0f98353f0632fb8be3ff192f8f4 Mon Sep 17 00:00:00 2001 From: shstat1729 Date: Wed, 30 Oct 2024 17:16:51 +0900 Subject: [PATCH] Publishing --- _sources/docs/Framework_for_FDAs_RWE_Program_2.md | 13 +++++++------ docs/Framework_for_FDAs_RWE_Program_2.html | 13 +++++++------ 2 files changed, 14 insertions(+), 12 deletions(-) diff --git a/_sources/docs/Framework_for_FDAs_RWE_Program_2.md b/_sources/docs/Framework_for_FDAs_RWE_Program_2.md index 61e8674..9d8acf7 100644 --- a/_sources/docs/Framework_for_FDAs_RWE_Program_2.md +++ b/_sources/docs/Framework_for_FDAs_RWE_Program_2.md @@ -62,12 +62,13 @@ - 연구 설계 및 분석의 투명성 확보가 결과에 대한 신뢰를 보장하는데 중요함 #### Regulatory Considerations for Study Designs Using RWD - - Use of Electronic Source Data - - Electronic Source Data in Clinical Investigations (2013) - - Use of EHR in Clinical Investigations (2018) - - Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Q&A (2017) - - Regulatory Considerations for Clinical Studies generating RWE - - FDA는 RCT에서 생성된 데이터가 RWE 생성에 사용될 경우 어떻게 다룰 것인지도 평가 할 것 + +- Use of Electronic Source Data + - Electronic Source Data in Clinical Investigations (2013) + - Use of EHR in Clinical Investigations (2018) + - Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Q&A (2017) +- Regulatory Considerations for Clinical Studies generating RWE + - FDA는 RCT에서 생성된 데이터가 RWE 생성에 사용될 경우 어떻게 다룰 것인지도 평가 할 것 #### Data Standards – Appropriate Data Standards for Integration and Submission to FDA - FDA는 RWD/RWE를 활용하기 위해 필요한 데이터 표준 및 구현 전략을 평가하고 FDA 규제의 필수적인 부분이 되도록 보장하기 위한 노력을 할 것 diff --git a/docs/Framework_for_FDAs_RWE_Program_2.html b/docs/Framework_for_FDAs_RWE_Program_2.html index 8bbc71e..3ec347d 100644 --- a/docs/Framework_for_FDAs_RWE_Program_2.html +++ b/docs/Framework_for_FDAs_RWE_Program_2.html @@ -506,13 +506,14 @@

Potential for Study Designs Using RWD to Support Effectiveness

Regulatory Considerations for Study Designs Using RWD#

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- Use of Electronic Source Data
-- Electronic Source Data in Clinical Investigations (2013)
-- Use of EHR in Clinical Investigations (2018)
-- Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Q&A (2017)
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