tailieunhanh - Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection

In the early stages of the planning process your plan will not contain definitive information, but it will help to keep you on track and will reassure partners and stakeholders that you are planning a safe, well -thought out and organised event. As the planning progresses, you will be updating this document and you should make sure that your fellow event organisers are updating their relevant areas of responsibility as well. All those undertaking key roles on the event day should receive a copy of the final Event Management Plan (EMP) in advance, to allow time. | Guidance for Clinical Investigators Sponsors and IRBs Adverse Event Reporting to IRBs Improving Human Subject Protection . Department of Health and Human Services Food and Drug Administration Office of the Commissioner OC Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER Center for Devices and Radiological Health CDRH Office of Good Clinical Practice OGCP January 2009 Procedural Guidance for Clinical Investigators Sponsors and IRBs Adverse Event Reporting to IRBs Improving Human Subject Protection Additional copies are available from Office of Communication Division of Drug Information Building 51 Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Bldg. 51 rm. 2201 Silver Spring MD 20993-0002 Tel 301-796-3400 Fax 301-847-8714 E-mail druginfo@ http Drugs GuidanceComplianceRegulatoryInformation Guidances and or Office of Communication Outreach and Development HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike Rockville MD 20852-1448 Tel 800-835-4709 or 301-827-1800 E-mail ocod@ http BiologicsBloodVaccines GuidanceComplianceRegulatoryInformation Guidances and or Division of Small Manufacturers International and Consumer Assistance Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Avenue Bldg. 66 rm. 4621 Silver Spring MD 20993-0002 . Tel 1-800-638-2041 or 301-796-7100 Fax 301-847-8149 E-mail dsmica@ http MedicalDevices DeviceRegulationandGuidance GuidanceDocuments . Department of Health and Human Services Food and Drug Administration Office of the Commissioner OC Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER Center for Devices and Radiological Health CDRH Office of Good Clinical Practice OGCP January 2009 Procedural .