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shstat1729 committed Oct 30, 2024
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13 changes: 7 additions & 6 deletions _sources/docs/Framework_for_FDAs_RWE_Program_2.md
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- 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
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13 changes: 7 additions & 6 deletions docs/Framework_for_FDAs_RWE_Program_2.html
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Expand Up @@ -506,13 +506,14 @@ <h3>Potential for Study Designs Using RWD to Support Effectiveness<a class="head
</section>
<section id="regulatory-considerations-for-study-designs-using-rwd">
<h3>Regulatory Considerations for Study Designs Using RWD<a class="headerlink" href="#regulatory-considerations-for-study-designs-using-rwd" title="Permalink to this heading">#</a></h3>
<div class="highlight-none notranslate"><div class="highlight"><pre><span></span>- 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&amp;A (2017)
</pre></div>
</div>
<ul class="simple">
<li><p>Use of Electronic Source Data</p>
<ul>
<li><p>Electronic Source Data in Clinical Investigations (2013)</p></li>
<li><p>Use of EHR in Clinical Investigations (2018)</p></li>
<li><p>Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Q&amp;A (2017)</p></li>
</ul>
</li>
<li><p>Regulatory Considerations for Clinical Studies generating RWE</p>
<ul>
<li><p>FDA는 RCT에서 생성된 데이터가 RWE 생성에 사용될 경우 어떻게 다룰 것인지도 평가 할 것</p></li>
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