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Data & Safety Monitoring for Clinical Trials ResearchGo UCLA

WebThe NIH requires data and safety monitoring for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase …

Actived: Just Now

URL: https://www.researchgo.ucla.edu/data-safety-monitoring-clinical-trials

ClinicalTrials.Gov ResearchGo UCLA

WebThe US National Institutes of Health (NIH) Policy on the Dissemination of NIH-Funded Clinical Trial Information of 2016 establishes the expectation that all NIH-funded …

Category:  Health Go Health

Applicable Clinical Trials ResearchGo UCLA

WebApplicable Clinical Trials [accordion collapsed] Definition of a Clinical Trial The World Health Organization (WHO) defines a clinical trial as “any research study that prospectively …

Category:  Health Go Health

Access Electronic Health Records ResearchGo UCLA

WebIf needed, Informatics collaborates with the Biostatistics Program to integrate electronic health record (EHR) data with other kinds of data and analytic efforts. …

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Biostatistics ResearchGo UCLA

WebPhone: 310-248-8901, fax: 310-423-4020. Office: Pacific Theatres Building, 116 North Robertson Blvd. Suite 900C, Los Angeles, CA 90048. Last updated: 1 Feb 2024. …

Category:  Health Go Health

Guidance, Tools and Templates ResearchGo UCLA

WebIRB Guidance for All Research Studies. Documentation of informed consent: Federal and state regulations direct that informed consent be documented, in general, …

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Sponsor Monitoring and Auditing for Clinical Research Studies

WebSponsor Monitoring and Auditing for Clinical Research Studies For clinical research studies where a study sponsor is obligated by the FDA to monitor study source records, …

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IRB Process / IBC Process ResearchGo UCLA

WebFor general questions, contact the OHRPP's main phone numbers (310) 825-5344 for the Medical IRB or (310) 825-7122 for the General Campus IRB. For questions specific to …

Category:  Medical Go Health

What is 21 CFR Part 11

WebWhat is 21 CFR Part 11? 21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally …

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CareConnect/Research Connect ResearchGo UCLA

WebWhat is CareConnect? (overall Epic) CareConnect is UCLA's electronic health record (EHR) program, which integrates inpatient and outpatient clinical records with appointments, …

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Scientific Review Committee ResearchGo UCLA

WebScientific Review Committee Established in September 2016 and formally mandated in July 2022, the UCLA Scientific Review Committee (SRC) provides a …

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Investigator Support Services

WebServices provided by this office include: Scientific and Feasibility Review, Data and Safety Monitoring, internal monitoring and auditing support, FDA and Sponsor inspection/audit …

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OnCore ResearchGo UCLA

WebOnCore is a clinical trials management system (CTMS) used at UCLA for the management of clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions at the study and subject level along with participant contact information, tracking deadlines and milestones.

Category:  Health Go Health

Coverage Analysis ResearchGo UCLA

WebCoverage Analysis (CA) is a financial review of a Clinical Research Study that is required to be performed pursuant to the Federal Clinical Trials Policy (also known …

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Office of Regulatory Affairs ResearchGo UCLA

WebDescription of Services. The Office of Regulatory Affairs (ORA) provides a broad spectrum of support for Clinical Investigators and their study teams in the conduct …

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Embedded Clinical Research and Innovation Unit (ECRI)

WebThis network focuses on breast cancer screening prevention studies, including the WISDOM study. WISDOM is a collaboration between all UCs and The Sanford …

Category:  Cancer Go Health

COVID-19 Information ResearchGo UCLA

WebThe CTSI Clinical Research COVID-19 help desk mailbox is now live. The purpose of the mailbox is to help capture and facilitate inquiries related to conducting COVID-19 …

Category:  Health Go Health

CareConnect/ ResearchConnect Access and Training

WebPlease call 310-267-2273 (7Care) to place a ServiceNow ticket for any assistance needed with ResearchConnect (e.g. Study Activation workflows, How to Use OnCore..etc) or CareConnect (e.g. Create OrderSet/SmartSet..etc). Last updated: 26 Aug 2022. Please click the following link to access the UCLA CareConnect Training Website and …

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HIPAA Information & Training ResearchGo UCLA

WebAll faculty, staff, house staff, students, contractors and volunteers will be expected to complete the HIPPA Education and Training Program module and test. This …

Category:  Health Go Health

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