Hub.ucsf.edu

HUB Clinical Research Resources Clinical Research …

WEBExplore resources, expertise, and best practices for: Who You Are. Investigators Study Staff Participants. Stage of Research. Design Study Set Up Study Conduct Study

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URL: https://hub.ucsf.edu/

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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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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Data Management Guidance, Tools & Resources Clinical …

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

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The IND Development Process Clinical Research …

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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ClinicalTrials.gov: Definition of a Clinical Trial

WEBThe World Health Organization (WHO) defines a clinical trial as “any research study that prospectively assigns human participants or groups of humans to …

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UCSF Investigator Education Clinical Research Resource …

WEBThe Training in Clinical Research (TICR) program offers a broad array of educational opportunities in the methods of clinical research to meet the diverse needs …

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About the HUB Clinical Research Resource HUB

WEBHUB Vision. The HUB is a virtual Clinical Research Resource that provides a single portal to a wealth of resources, expertise, and best practices for investigators …

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Study Design Resources Clinical Research Resource HUB

WEBClinical Informatics Resources. Biostatistics Consultation. Study Design and Implementation Consultation. Clinical Data Related to Research - Electronic Health Record. Clinical …

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Trial Management Clinical Research Resource HUB

WEBOnCore. OnCore is a clinical trial management system (CTMS) that enables the management of research, safety, regulatory, financial, biospecimen, and operational …

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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 …

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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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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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Research Participant FAQ Clinical Research Resource HUB

WEBA clinical trial is a research project conducted with men, women or children to determine if an investigational drug, device or procedure is safe and effective. A …

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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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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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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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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. Then, call OHS at 415 …

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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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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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