This day will ensure that you fully understand the practical realities of clinical research contracts. Examine what is included in the clinical research model contract, unmask essential confidentiality, indemnity and intellectual property issues, understand the model non-commercial clinical trial agreement and material transfer agreements, share examples of negotiation, modification and how to avoid classic pitfalls, gain insight into foreign sponsors: working with the US and Europe and identify which key areas Trusts should focus on for nonstandard agreements.
Many attendees to this event completed an evaluation form, and we are pleased to share with you some of the comments made about this day:
Very valuable practical direction on how to review a contractImperial College London
Excellent, informative, delightful presenters and relevant experience and knowledgeOxford Health NHS Foundation Trust
An extremely informative day and inclusion of case studies and day to day examples helped put the information into contextCwm Taf University Health Board
This event has been very valuable and opened up a breadth of knowledge which I would be able to apply to my jobCentral and North West London NHS Foundation Trust
The course has clarified areas to look out for when reviewing contracts. I feel more confident in what to be aware ofSt Stephen's AIDS Trust
Large volume of useful and practical information, well presented in a digestible format on the wholeTaunton and Somerset NHS Foundation Trust
It was a good day with interesting talks and material that I will use in my job in the futureSt Georges University of London
Really useful event, learned a lot with practical tips on what to look out for in research contractsNorthamptonshire Healthcare NHS Trust
Relevant and beneficial content - will facilitate daily practiceHinchingbrooke Healthcare NHS Trust
I have found the whole event extremely informative, speakers have been easy to follow and I feel I have developed my knowledge in research contractsRoyal Berkshire NHS Foundation Trust
The documentation from Structuring and Reviewing Clinical Research Contracts 2015 which took place on 04 March 2015 in London Gatwick, includes the following presentations:
- Fundamentals of Clinical Research Contracts - • Examining what is included in the clinical research model contract • Sharing practical insight: simplifying terminology and levels of coverage explained • Understanding different elements of contract risk • Allocation of rights and responsibilities, and governance check • Unmasking essential confidentiality, indemnity and intellectual property issues • Practical hints and tips on setting out and embedding finances • Model non-commercial clinical trial agreement (mNCA) and material transfer agreements
- Making Modifications to the Standard Model Contracts for Clinical Research - • Introduction to the suite of model contracts: what they cover and when to use them • Sharing examples of common areas of negotiation and modifications, and avoiding classic pitfalls • Gaining legal insight into acceptable changes: ensuring you are covered • Inclusion of foreign law provisions when working with international companies
- Contracting outside of the Clinical Research Model Agreement Remit - • Understanding the range of clinical studies and their different contracting needs • Reviewing the benefits and risks of formal contracts vs appropriate documentation • What key areas should Trusts focus in on for nonstandard agreements? • A quick guide to Human Tissue Agreements: when might the protocol be enough? • Best practice sub-contracting outside the NHS and between NHS organisations • Foreign sponsors: overcoming the tricky aspects of working with the US and Europe • Understanding the requirements of IMP Manufacturing
- Legal Clinic: Common Areas of Dispute and Practical Examples of Clinical Research Contracts - • How do you handle IPR? Insight into the NIHR – changing their IP provisions • Avoiding disputes: essential insight to safeguard your interests • Practical guidance and experienced reassurance: quick legal insight into areas of concern • Examples and case studies of common hurdles and trip points for NHS Trusts
Conference documentation in both hard and electronic copy is available for purchase at £89 (there is no VAT charge). In addition to being posted a copy, all the documentation is now available to you in electronic format so that you can access the papers and presentations online.
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