[2] DeVito NJ, Goldacre B. Evaluation of Compliance With Legal Requirements Under the FDA Amendments Act of 2007 for Timely Registration of Clinical Trials, Data Verification, Delayed Reporting, and Trial Document Submission. JAMA Intern Med. 2021;181(8):1128–1130. doi:10.1001/jamainternmed.202...
他们指出 , 尽管数以千计的试验不符合 FDAAA 的报告要求,但 FDA 和 NIH 都没有利用其实施罚款或扣留拨款的法律授权。 [1] Ramachandran R, Morten CJ, Ross JS. Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements. JAMA. Published online November 12, 2021. doi:10.1001/jama...
• 临床试验基础设施和组织文化。Upcoming：FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference 美东时间2024年3月20日-3月21日，BIMO-W和SOCRA将联合举办一次题为“FDA 临床试验要求、法规、合规性和 GCP 会议”的研讨会。该研讨会旨在让FDA代表和受监管社区之间分享信息，促进对法...
2.2.1 SDRG for Clinical Data 临床研究的SDRGAn SDRG for clinical data should be named cSDRG (the prefix ‘c’ designates ‘clinical’) and the document should be named ‘csdrg’ and provided as a PDF file uponsubmission (csdrg.pdf).临床数据的SDRG应命名为cSDRG(前缀“c”表示“临床”),文...
Compliance and GCP FDA Clinical Trial Requirements Regulations , Compliance and GCPFDA Clinical Trial Requirements Regulations , Compliance and GCPProgram, Cosponsored
requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. ...
FDA Clinical Trial Requirements Regulations, Compliance, and Good Clinical Practice Conference; Public WorkshopJeffrey Shuren
Use of video conferencing for trial visits 28 Q22. Postmarketing requirements for drugs, biologics, and devices 29 Q23. Reporting serious adverse events for approved drugs used to treat COVID-19 31 Q24. Reporting serious adverse events associated with COVID-19 in a non-COVID trial 32 Q25....
In December 2023, FDA issued the "Master Protocols for Drug and Biological Product Development Guidance for Industry (Draft)" to describe the requirements for the design, implementation and analysis of clinical trials using the master protocol. This paper introduces the guidance in detail, focusing ...
Upcoming:FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference 美东时间2024年3月20日-3月21日,BIMO-W和SOCRA将联合举办一次题为“FDA 临床试验要求、法规、合规性和 GCP 会议”的研讨会。 该研讨会旨在让FDA代表和受监管社区之间分享信息,促进对法规、指南和实践的理解,并提出增强研究专...