Choose the definition for Plagiarism: A. Making up data or results and recording or reporting them.B. Changing the research record so that it does not accurately reflect the research findings.C. Using another person's ideas, processes, results, or words without giving credit. Choose the definit...
Choose the definition for Plagiarism: A. Making up data or results and recording or reporting them.B. Changing the research record so that it does not accurately reflect the research findings.C. Using another person's ideas, processes, results, or words without giving credit. Choose the definit...
Definition of an Investigational New Drug 研究新药的定义 The Code of Federal Regulations (CFR) defines an investigational new drug as: "...a new drug or biological drug that is used in a clinical investigation." 联邦法规(CFR)将试验新药定义为: “……用于临床研究的新药或生物药物。” In the ...
Ⅰ、Federal policy defines research misconduct as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” This definition does not include honest error or differences of opinion or authorship disputes unless they involve plagiarism. ...
CharlesPierce,MD,PhD,CPIandHowardGreenberg,MD,“InvestigatorResponsibilitiesinClinicalResearch–ICHViewpoint,”TheMonitor25(5),(2011).(SeptemberACRPpublication)RegulationsandStandards法规和标准 RegulationsandStandards法规和标准 GoodClinicalPractice(GCP)药品临床试验管理规范 –Astandardforthedesign,conduct,...
Federal regulations do not limit the definition of “injury” to a physical injury. An injury may be psychological, social, financial, or of another nature. 同意书必须说明(ICH GCP 4.8.10): (1)在试验相关伤害事件中,参与者可获得的补偿和/或治疗。 (2)参与者参与试验的预期费用(如有)。 注意事...
The ICH GCP definition of 'audit' focuses on compliance assessment, and this is also an expectation of the regulatory authorities. However, auditing in clinical research has evolved over the years to be far more value-added to an organisation than only assessing compliance with regulations. The ...
Part 2: Contents of the Research Protocol (ICH E3 GCP 6) Part 1: Introduction Documents to Ensure Standardization 确保标准化的文件 Standardization — everyone doing the same things in the same way — is critical in a clinical research study and particularly critical for multisite trials. Research...
investigational product (synonym: study product) Any pharmaceutical product (see definition) or placebo being tested or used as a reference in a clinical trial. investigator's brochure A collection of data for the investigator consisting of all the relevant information on the investigational product(s...
investigational product (synonym: study product) Any pharmaceutical product (see definition) or placebo being tested or used as a reference in a clinical trial. investigator’ s brochure A collection of data for the investigator consisting of all the relevant information on the investigational product...