Regarding the activities of The Clinical Trials Support Desk, SIOPEis currently launching a call for experts in the field to participate and share their expertise with others via the corresponding Clinical trials working-groups that have been set up as follows:

Protocol Guidelines Working Group

Aim & Tasks

• Standardisation of protocol templates for Phase II and III trials
• Creation of standard template for data collection and CRF design including the following:

          i. Defining the minimum and maximum required data

          ii. Advising on toxicity data collection (Pan European definitions on SAE and SUSARs)

          iii. Creating the end of treatment summary forms

          iv. Standardising (procedures) for long term follow up beyond the trial

Regulation Working Group

Aim & Tasks

• Balance of clinical trials versus the best practice guidelines
• Pan-European clinical trial sponsorship
• Pharmacovigilance and safety

           i.   Monitoring and audit requirements in clinical academic trials

           ii.  Trans-european harmonisation and implementation of expedited reporting of SAEs and SUSARS

• Role of  Data Monitoring Committees
• Pan European harmonisation of sponsor duties in academic trials  
• Declaration of IMP’s
• Creation of CTA (Clinical Trials Application process)
• Risk based requirements for insurance in clinical trials
• Central European registration and information on clinical trials open to public
• Recommendation to standardise documents such as the structure of trials mast file (TMF)

Ethics Working Group

Aim & Tasks

• Review key ethical differences for paediatrics across Europe

          i.  Age of competency

          ii. Need for parental consent

          iii. Attitude to phase I trials

          iv. Guidance towards harmonisation for the composition and working procedures of administrative authorities

          v. Ethical review standards and procedures for EU member states

          vi. Educational programmes for officers and   

• Setup key items for patient information and consent forms:

          i. Consent for access to tissues for research

          ii. Consent for future contact for long term follow up

• Work on national regulation on tissues storage and use in research:

          i. Consent to share tissues outside of countries and the EU

          ii. Permission to share with potential commercial benefits of the pharma

          iii. Generic consent for future research

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If you have any queries or would like to share information with us, please contact Ms. Samira Essiaf at: samira.essiaf<at>ecco-org.eu (please repleace <at> with @)