Difference between revisions of "Reference Library"
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(Created page with "''As content accumulates, can think about appropriate organization.'' *Guidance Standards for CTs *Media:Guidance biomarker qualifi...") |
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| − | ''As content accumulates, can think about appropriate organization.'' | + | ''As content accumulates, we can think about appropriate organization.'' |
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| − | *[ | + | * [[QIBA in the Literature Citations]] |
| − | *[[Media:EU.2009.08.04 Guideline on Clinical evaluation of diagnostic agents.pdf| | + | *[[Media:List of 2018-2019 Imaging-Related conferences(updated 09-04-2018).pdf|2018-2019 Imaging-Related Conferences with links]] |
| − | *[[Media:EU.2009.08.04 Appendix 1 to the guideline.pdf| | + | |
| − | *[ | + | * [[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: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]] | ||
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| + | * [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] | ||
Latest revision as of 20:44, 4 September 2018
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.