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ClinicalTrials.gov: Definition of a Clinical Trial

Web05/14/2015. The World Health Organization (WHO) defines a clinical trial as “any research study that prospectively assigns human participants or groups of humans to one or more …

Actived: 4 days ago

URL: https://hub.ucsf.edu/clinicaltrialsgov-definition-clinical-trial

Clinical Trial Protocol Development

Web09/21/2022. Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the …

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ClinicalTrials.gov: Applicable Clinical Trials Clinical Research

WebDefinition of a Clinical Trial; The World Health Organization (WHO) defines a clinical trial as “any research study that prospectively assigns human participants or …

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Resources for New Coordinators Clinical Research Resource HUB

WebTo schedule an appointment, the supervisor or Human Resources representative should complete a Request for Service form and fax it to 415-771-4472. …

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Suggested Training for Clinical Research Coordinators

WebData Management Tools available online include RedCap, MyResearch, & Research Data Browser. REDCap is a secure, web-based application for building and …

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Training Clinical Research Resource HUB

Web05/10/2019. Are you an investigator looking to step up your skills in clinical and translational research? Browse opportunities from didactic coursework to career development awards, …

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The IND Development Process Clinical Research Resource HUB

WebThis toolkit (adapted from The Institute of Translational Health Sciences) helps you navigate each step of the IND process by providing guidance and templates …

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Data Management Guidance, Tools & Resources Clinical Research

WebData Management Guidance, Tools & Resources. As of Jan 2023 NIH now requires that all grants that generate research data include a Data Management and …

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OnCore Clinical Research Resource HUB

WebLast revised: 04/24/2024. Overview. OnCore offers several modules to support clinical research at UCSF. Support. OnCore Access & Training. OnCore Resources. OnCore …

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Examples of Reportable Safety Events

Web08/26/2014. Checklist: Examples of Reportable Safety Events. Adverse Events - Adverse events are events that are undesirable and unintended, although not necessarily …

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Training to access and use UCSF electronic health record data

WebAPeX (Advanced Patient-Centered Excellence) is UCSF’s electronic EPIC based, Medical Record System (EMR) and electronic health record (EHR) system data …

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Standard Operating Procedures Clinical Research Resource HUB

WebStandard Operating Procedures (SOPs) are uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed …

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ClinicalTrials.gov: General FAQs

WebThe ClinicalTrials.gov protocol registration/results reporting system interface was originally developed prior to 2000 when ‘results reporting’ was not a requirement. …

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Prepare the Initial IND Submission

WebThe initial IND submission should be accompanied by a cover letter, an IND Application Form - FDA 1571 ( see instructions) and a Certification of Compliance - FDA …

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Questions to Ask Before Joining a Research Study

WebQuestions to Ask Before Joining a Research Study. As a participant you should know as much as possible about the clinical trial and feel comfortable asking the …

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FDA Inspection Guidance, Tools & Templates

WebCustomizable template that outlines the process for an FDA/OHRP inspection, and describes activities that should be done to facilitate the inspection. …

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21 CFR Part 11 Compliance: System Validation Clinical Research

WebA system validation plan provides a roadmap for project personnel. It defines the scope of work, user needs, expected work products (i.e., documentation, hardware, …

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Clinical and Translational Science Institute / CTSI

WebInternational Conference on Harmonisation (ICH) Documents and Good Clinical Practice (GCP) E6 GCP is an Ethical and Scientific Standard for the design, conduct, analysis of …

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Medical Center and Campus Safety Training

Web12/16/2020. Safety training is available via the UC Learning Center. It is necessary for Campus staff who work in the Medical Center to complete the required Medical Center …

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