Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/
Draft Guidance Documents: Good Clinical Practice
Draft guidance documents have been proposed and are issued for public comment. Each FDA draft document lists how to submit comments to the agency.
The entries below are listed in reverse chronological order by publication date.
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Draft Guidance Documents
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed (PDF - 62KB) 2-11/2012
Electronic Source Data in Clinical Investigations (PDF - 271KB) 3-11/2012
Considerations When Transferring Clinical Investigation Oversight to Another IRB 4-06/2012
- Exculpatory Language in Informed Consent (PDF - 112KB) 5-08/2011
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 149KB) 6-08/2011
- Design Considerations for Pivotal Clinical Investigations for Medical Devices 7-08/2011
- Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review 8-08/2011
- In Vitro Companion Diagnostic Devices 9-07/2011
- Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions 10-06/2011
- Financial Disclosure by Clinical Investigators (PDF - 151KB) 11-05/2011
Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 210KB) 12-10/2010
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies - Draft Guidance - 9/2010 (PDF - 687KB) 13-09/2010
IRB Continuing Review After Clinical Investigation Approval - Draft Guidance (PDF - 244KB) 14-01/2010
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions - Draft Guidance (PDF - 34KB) 15-03/2002
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