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Clinical Trial Roadmap

Weba practical guide to the clinical trials journeY DEVELOPED BY NSW REGIONAL HEALTH PARTNERS FOR REGIONAL NSW What is the Clinical Trials Roadmap? The Clinical …

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URL: https://ctroadmap.hmri.org.au/

Investigator Initiated Trials – Clinical Trial Roadmap

WebInvestigator Initiated Clinical Trials Investigator Initiated Clinical Trials If you have an idea for a clinical trial but aren’t sure what to do next, this part of the Roadmap might help. …

Category:  Health Go Health

Standard Operating Procedures – Clinical Trial Roadmap

WebStandard operating procedures help standardise key clinical trial operations. As a Coordinating Principal Investigator, you are responsible (in consultation with your …

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Clinical Trial Protocol – Clinical Trial Roadmap

WebThe Office for Health and Medical Research have developed a suite of Resources and templates in the Clinical Trial Toolkit to support the conduct of high-quality trials and to …

Category:  Medical Go Health

Research Feasibility – Clinical Trial Roadmap

WebInvestigator Initiated Trials Test Your Idea Research Feasibility When developing a clinical trial, you should:Familiarise yourself with the relevant research regulatory framework e.g. …

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Confidentiality and Non-Disclosure Agreements

WebSponsored Trials Confidentiality and Feasibility Confidentiality and Non-Disclosure Agreements A confidentiality and non-disclosure agreement (CDA or NDA) is a legal …

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Demonstrating Research Impact – Clinical Trial Roadmap

WebIt is important to articulate the value of the trial to your patient community and the health district (e.g. new treatment option, safer surgical procedures) through an impact …

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Files for Essential Trial Documents – Clinical Trial Roadmap

WebFiles need to be prepared for storing the essential documents for a clinical trial. A Trial Master File (TMF) is held by the sponsor and Investigator Site Files (ISF) are held at …

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Access Request Review for Participants, Their Tissue or Data

WebInvestigator Initiated Trials Research Ethics, Governance and Regulatory Approvals Access Request Review for Participants, Their Tissue or Data Clinical trials that involve access …

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Memorandum Of Understanding – Clinical Trial Roadmap

WebSponsored Trials Agreement Negotiation Memorandum Of Understanding A Memorandum of Understanding (MOU) is an alternative form of documentation that may be used to …

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Clinical Trial Research Agreements – Clinical Trial Roadmap

WebSponsored Trials Agreement Negotiation Clinical Trial Research Agreements Externally sponsored clinical trials, commercial and non-commercial, conducted at NSW public …

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Insurance and Indemnification – Clinical Trial Roadmap

WebInsurance and indemnity requirements for clinical trials vary greatly across different countries, healthcare systems and institutions and are influenced by both clinical trial …

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Access Request Review for Participants, Their Tissue or Data

WebSponsored Trials Research Ethics, Governance and Regulatory Approvals Access Request Review for Participants, Their Tissue or Data Clinical trials that involve access to …

Category:  Health Go Health

Feasibility Assessment – Clinical Trial Roadmap

WebIt is critical to undertake a feasibility assessment prior to electing to participate in a clinical trial. you must be certain that the clinical trial is right for your site and your patient cohort. …

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Ethics Applications – Clinical Trial Roadmap

WebSponsored Trials Research Ethics, Governance and Regulatory Approvals Ethics Applications Ethics approval establishes whether you should do this research. All …

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Clinical Trials Support – Clinical Trial Roadmap

WebIf you need help navigating the start-up of your clinical trial, you can engage the HMRI Clinical Trials Unit (CTU) to support you throughout your trial, or in specific areas only. If …

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Trial Supplies – Clinical Trial Roadmap

WebInvestigator Initiated Trials Supporting Documentation Trial Supplies Depending on the type of clinical trial, trial supplies such as trial drugs or medical devices, specialised …

Category:  Medical Go Health

Site Activation – Clinical Trial Roadmap

WebSponsored Trials Site Activation Site study staff should work closely with the Sponsor and any site staff supporting the study start-up to complete all trial start-up arrangements. …

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Cultural Governance – Clinical Trial Roadmap

WebThe Office of Health and Medical Research has developed the Quick Guide to undertaking Appropriate Aboriginal Health Research.This document provides advice and key …

Category:  Medical Go Health

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