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INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2)

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve…

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TransCelerate RBM Volume II 15JUL2014

TransCelerate’s Risk-Based Monitoring (RBM) project has been productive in the first half of 2014. The purpose of RBM Update Volume II is to share new and relevant information on the accomplishments of the RBM workstream including the following: RACT version 2.0 released on April 29, 2014 Central Monitoring Capability Technology Considerations to Enable RBM External Engagement Upcoming Deliverables in…

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TransCelerate RBM Volume I 27JAN2014

TransCelerate’s Risk-Based Monitoring (RBM) project had a very productive year in 2013. Subsequent to publishing the Position Paper on Risk-Based Monitoring Methodology in May 2013, we have actively worked to network the concepts and embarked on piloting and/or assessing experience among companies that implemented the methodology. The purpose of this RBM Update document is to share the following information…

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TransCelerate RBM Position Paper 30May2013

Current On-site Monitoring practices are frequency-based, conform to a prescribed monitoring visit schedule, and provide generalized quality control at investigational sites. Although this practice does provide a level of control, advances in risk-based approaches and technology provide an opportunity for a more holistic and proactive approach through Off-site and Central Monitoring and a targeted approach to On-site Monitoring. By…

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FDA Guidance on RBM (2013)

This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects…

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EMA Reflection Paper on RBM (2013)

Good clinical practice (GCP)1 is a set of internationally recognised ethical and scientific standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. ICH GCP requires in Section 5.1, that the sponsor implements and maintains systems for quality assurance and quality control; similarly the Article 2 of the GCP Directive 2005/28/EC requires the implementation…

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ICD E6 (R2) EMA Adopted Guidelines (Jan 2017)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that…

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