Difference between revisions of "Reference Library"
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*[[Media:Guidance Standards for CTs.pdf|Guidance for Industry, Standards for Clinical Trial Imaging Endpoints]], Food and Drug Administration, August 2011. | *[[Media:Guidance Standards for CTs.pdf|Guidance for Industry, Standards for Clinical Trial Imaging Endpoints]], Food and Drug Administration, August 2011. | ||
*[[Media:Guidance biomarker qualification Aug 2011.pdf|Guidance for Industry, E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions]], Food and Drug Administration, August 2011. | *[[Media:Guidance biomarker qualification Aug 2011.pdf|Guidance for Industry, E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions]], Food and Drug Administration, August 2011. | ||
| + | *[[Media:EU.2009.08.04 Guideline on Clinical evaluation of diagnostic agents.pdf|Guideline on Clinical Evaluation of Diagnostic Agents]], European Medicines Agency, July 2009. | ||
| + | **[[Media:EU.2009.08.04 Appendix 1 to the guideline.pdf|Appendix 1 to the Guideline on Clinical Evaluation of Diagnostic Agents]] | ||
*[http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule] | *[http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule] | ||
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Revision as of 23:47, 3 May 2016
As content accumulates, we can think about appropriate organization.
- Guidance for Industry, Standards for Clinical Trial Imaging Endpoints, Food and Drug Administration, August 2011.
- Guidance for Industry, E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions, Food and Drug Administration, August 2011.
- Guideline on Clinical Evaluation of Diagnostic Agents, European Medicines Agency, July 2009.