2014

EU funded clinical research 14/10/2014

All grant applications for European funding, including Horizon 2020, which include a clinical research component, whether co-ordinated from Dundee or not, must be registered with TASC, Finance and the EFA at the earliest opportunity.   Contacts are as follows: -

TASC (Tayside Medical Science Centre) - the University & Tayside Health Board joint R&D Office. Email [email protected]

Finance

For the School of Medicine, SFO - the School Finance Office.

Email [email protected]

OR

For the Schools of Dentistry of Nursing or elsewhere, RFS - Research Finance Services

Email [email protected]

European Funding Advisor (EFA) Neil Stewart

Email [email protected]

Registration is made by sending the draft proposal or study summary to the mailboxes detailed above.  Ideally, this should be in advance of the Project Registration Form (PRF) as TASC will work with you to complete the PRFs.

Early registration allows all internal support offices the opportunity to work with you to assess the resource and risk associated with the research, to work in conjunction with each other and to provide essential information to external partners.

TASC Support Available

The key people in TASC who will support you with these applications are: -

•                 ``````````` Risk Assessment, Sponsorship & Governance
• Liz Coote                       NHS Resource Cost Analysis & NHS Management Approval
• Fiona Hogarth                Tayside Clinical Trials Unit
• Euan Banyard                 Site Set Up - Multi-Site Studies
• Lesley Peebles               Clinical Research Facilities & Research Nurse Service

Registrations to [email protected] will be circulated to these TASC staff.

Involving TASC in the proposal development and participant pathway will help to i) design and deliver the study ii) identify study specific activities and iii) define costs. Costs may include, for example, international GCP monitoring, translation of trial documentation, drug management or research nurse support. It is essential that specific costs are identified and attributed to the correct budget.

 Where a study involves Tayside Health Board, Investigators must consider making the Board a named partner in the bid application.

Monitoring of Non-Commercial Hosted CTIMPs (18/03/2014)

TASC provide GCP Monitoring of Clinical Trials of Investigational Medicinal Products (CTIMPs) which are sponsored or co-sponsored by University of Dundee and/or NHS Tayside. The level of monitoring carried out is dependent upon the type of trial and the risk associated with it.

Where NHS Tayside is asked to act as a Site for CTIMPs sponsored externally, TASC requests a Monitoring Plan from the trial Sponsor. Additionally, TASC provides monitoring of ~ 10% of all trials hosted by NHS Tayside including those which are designated as ‘high risk’. The high risk definition includes ‘Type C’ trials, those which involve biological or advanced therapy or healthy volunteers, including early phase trials, and trials involving paediatrics, pregnancy, emergency research or vulnerable adults.

Investigators should note that trials involving biological therapies must be conducted within the TASC Clinical Research Centre (CRC). These trials should be discussed, in early planning, with Lesley Peebles, TASC Clinical Research Manager [email protected]

If you require any additional information regarding GCP monitoring of CTIMPs, please contact  TASC Senior R&D Manager

For advice on registering non-commercial hosted CTIMPs and on obtaining NHS Tayside permission to conduct the trial, contact Liz Coote, TASC R&D Manager  [email protected]