WebMar 11, 2024 · Results Submission Process. PIs of ORD funded clinical trials must submit summary results for their clinical trials to ClinicalTrials.gov. This requirement applies to … WebAn applicable drug clinical trial is a controlled clinical investigation, other than a Phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and …
Policy and Regulation on ClinicalTrials.gov Registration and …
WebAs of 31 January 2024, all initial clinical trial applications in the EU/EEA must be submitted through the Clinical Trials Information System. EU CTR continues to display information on EudraCT trials. EudraCT remains available for amendments to EudraCT trials, creation of PIP/Art 46 third country files (see FAQs ), updating of EudraCT trials ... WebFeb 26, 2024 · TPS497 Background: Standard first-line treatment for patients (pts) with la/mUC is cisplatin-based chemotherapy or carboplatin-based chemotherapy for pts unfit for cisplatin. Immune checkpoint inhibitors (CPIs) are standard treatment options for pts who progressed during or after platinum-based chemotherapy. While some pts with la/mUC … professional sewing supplies seattle website
EV-301: Phase III study to evaluate enfortumab vedotin (EV) versus ...
WebClinicalTrials.gov is a web-based resource that provides patients/research subjects, their family members, health care professionals, researchers, and the public with easy access to information on federally and privately supported clinical studies on a wide range of diseases and conditions in the United States and across the world. WebMar 11, 2024 · Results Submission Process. PIs of ORD funded clinical trials must submit summary results for their clinical trials to ClinicalTrials.gov. This requirement applies to all ORD trials regardless of whether the trial meets the definition of an "Applicable Clinical Trial" as described in FDAAA 801 and the Final Rule. WebMar 24, 2024 · This regulation, 42 CFR Part 11 , is called the Final Rule for Clinical Trials Registration and Results Information Submission, or "Final Rule". The Final Rule describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov. The changes made to FDAAA 801 by the Final Rule are ... professional sewing supplies