Discusses legal and medical reasons why source documents are needed in clinical trials. Definition of a source document; Provision of supporting evidence that the data submitted to the United States Food and Drug Adm...
1. Providing strategic inputs and decision to plan and execution of studies includes clinical evaluation, clinical trials and/or research studies primarily for non-approved product registration in China and/or may support regulatory registration elsewhere;提供战略意见和决定参与计划和执行研究包括临床评估,...
The package ctrdata provides functions for retrieving (downloading), aggregating and analysing clinical trials using information (structured protocol and result data, as well as documents) from public registers. It can be used with theEU Clinical Trials Register (“EUCTR”, https://www.clinicaltrial...
We have to be realistic about any change, especially when it occurs in such a heavily regulated domain as clinical research. Yes, we can achieve uniformity by scrapping the whole passel of tools and replacing them with a single, integrated system, but we can’t expect from study teams and ...
ShanshanZhao, ...HanryYu, inDiabetes & Metabolic Syndrome: Clinical Research & Reviews, 2024 2Methods 2.1Data source and search strategy This study adheres to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standard. This study uses only publicly available data to conduc...
1. Participating in the design, planning, implementation and overall direction of clinical research projects. Contributing technical and clinical operation expertise (if apply); 参与临床研究项目的设计,规划,实施和总体方向;可以提供技术和临床操作专业知识(如适用)。
The Clinical Content & Reuse initiative, in addition to maintaining the CTS, has been involved with numerous innovative exploratory activities & collaborations aimed at enhancing the clinical research ecosystem. Click on the tabs below to learn more & see related tools and resources. ...
Research August 26, 2024 Tucatinib Combination Treatment in ERBB2 -Positive Metastatic Breast Cancer Research April 3, 2024 PIK3CA Mutation in Early-Stage ERBB2/HER2-Positive Breast Cancer Research December 20, 2023 Sign Up for Emails Based on Your Interests Others Also Liked We recommend A Time-...
HARMONIZED MODEL CONTENT Concise, consistent model wording used across multiple documents that aligns with GCP, ICH, requirements and includes feedback from stakeholders and regulators involved in clinical research. CLINICAL TEMPLATE SUITE (CTS) Includes Word and technology-enabled templates for the protoco...
22 This investment represents an evolution for the FDA from primarily relying on insurance claims for postmarketing research to using EHR data, which are a richer source of real-world clinical data and have a shorter reporting lag time than claims data. The proposal also aims to address the ...