Difference between revisions of "Reference Library"
Jump to navigation
Jump to search
| Line 1: | Line 1: | ||
''As content accumulates, we can think about appropriate organization.'' | ''As content accumulates, we can think about appropriate organization.'' | ||
| − | |||
| − | |||
| − | |||
| − | |||
| + | * [[Media:QIBA_in_the_literature_(updated 04 28 2016).pdf|QIBA and Quantitative Imaging Biomarkers Alliance Literature References]] - ''April 2016'' | ||
| − | *[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] | + | |
| + | * [[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]] | ||
| + | |||
| + | |||
| + | * [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] | ||
Revision as of 00:31, 4 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.