Summary This chapter contains sections titled: FDA Regulations – Informed Consent Possible Problems with Informed Consent Documentation of Informed Consent FDA Regulations – Institutional Review Boards FDA Investigator Responsibilities Documentation, Record Keeping and Record Retention Investigator Record Keeping ...
14.Pharmaceutical Quality Resource(药品质量资源):此部分包括Current Good Manufacturing Practice (CGMP) Regulations(现行良好生产规范(CGMP)条例)、CDER Quality Management Maturity(CDER质量管理量度)、Q&A on CGMP Requirements(关于CGMP要求的问答)、Inspection/Enforcement Resources(检查/...
14.Pharmaceutical Quality Resource(药品质量资源):此部分包括Current Good Manufacturing Practice (CGMP) Regulations(现行良好生产规范(CGMP)条例)、CDER Quality Management Maturity(CDER质量管理量度)、Q&A on CGMP Requirements(关于CGMP要求的问答)、Inspection/Enforcement Resources(检查/执法资源)及Questions and Answer...
research subjects involved in FDA-regulated clinical trials, to verify the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications, and to assess compliance with statutory requirements and FDAs regulations governing the conduct of clinical trials....
美国FDA(食品与药品监督管理局)和DHHS(卫生与公众服务部,Department of Health and Human Services)将贝尔蒙报告提出的原则纳入法律,起草和颁布了联邦法规(CFR, Code of Federal Regulations)第21章。 CFR第21章(简写为:21 CFR)是研究性药物临床研究的基本法规。
. A signed informed consent is evidence that the document and other pertinent information regarding the study has been provided to the prospective individual seeking to participate in the research. An IRB review of informed consents also ensures an institution’s compliance with appropriate regulations....
Patrick McNeilly,an official at the FDAwho handles trial enforcement matters, recently told an industry conference session on ClinicalTrials.gov that “FDA has limited resources, and we encourage voluntary compliance.” He said the agency also reviews reporting of information on ClinicalTrials...
医疗器械分类：《医疗器械分类规则》（Classification Regulations）：这些规则列出了不同类别的医疗器械，以及它们的风险级别和适用的法规要求。预市通报和预市批准：《预市通报指南》（Guidance on Premarket Notification）：这个指南解释了预市通报（510(k)）申请的要求和流程，帮助制造商了解如何证明其医疗器械的相当性...
Except as provided in§§ 50.22,50.23, and50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigat...
4. To further align our regulatory requirements with the provisions of Cures, CDRH also amended its current regulations to allow more devices to qualify for a humanitarian device exemption for small patient populations. We’ll allow researchers to seek approval for device clinical trials through a ...