Research Governance Framework definition

Research Governance Framework means the UK Policy Framework for Health and Social Care Research (Version 3.3, November 2017);
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Research Governance Framework means the UK Policy Framework for Health and Social Care Research (Version 3.3, November 2017); Regulatory Authority means any regulatory authority responsible for the review and approval of the Clinical Trial and the use of the IMP; Results means the research findings produced in the Clinical Trial; SAE means Serious Adverse Event and shall have the definition set out in the Medicines for Human Use (Clinical Trials) Regulation 2004;
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Examples of Research Governance Framework in a sentence

  • This SOP applies to all healthcare research sponsored by NNUH or UEA which falls within the scope of the Research Governance Framework (2nd edition 2005).

  • The study will be carried out in accordance with the ethical principles in the Research Governance Framework for Health and Social Care, Second Edition, 2005 and its subsequent amendments as applicable and applicable legal and regulatory requirements.

  • The Trial Steering Committee will be responsible for overall supervision on behalf of the Sponsor and Funder, and will ensure that it is conducted in accordance with the rigorous standards set out in the Department of Health’s Research Governance Framework for Health and Social Care and the Guidelines for Good Clinical Practice.

  • Applicants’ attention is drawn particularly to the specific responsibilities of the research sponsor, the principal investigator, and the host organisation for the research, defined in detail within the Research Governance Framework.

  • The study may be subject to inspection and audit by Imperial College London under their remit as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS Research Governance Framework for Health and Social Care (2nd edition).

  • This study will be performed according to the Research Governance Framework for Health and Community Care (Second edition, 2006) and The Medicines for Human Use (Clinical Trials) Regulations, 2004 SI 2004:1031 (as amended).

  • The collection and reporting of Adverse Events (AEs) will be in accordance with the Research Governance Framework for Health and Social Care and the requirements of the National Research Ethics Service (NRES).

  • The Sponsor recognises that the Participating Organisation and Principal Investigator have a responsibility under the Research Governance Framework to ensure that results of scientific interest arising from the Non-Interventional Study are appropriately published and disseminated.

  • It will also be conducted in compliance with the approved protocol, the principles of Good Clinical Practice (GCP) as laid down by the Commission Directive 2005/28/EC with the implementation in national legislation in the UK by Statutory Instrument 2004/1031 (The Medicines for Human Use [Clinical Trials] Regulations 2004) and subsequent amendments, the UK Data Protection Act (DPA number: Z5886415), and the National Health Service (NHS) Research Governance Framework for Health and Social Care (RGF).

  • When the research trial is complete, it is a requirement of the Research Governance Framework and Sponsor Policy that the records are kept for a minimum period of 20 years (as per sponsor requirements).

Related to Research Governance Framework

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  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

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