Table 1.

Recommendations based on the ICR-CTSU experience

Operational area	Challenges	Recommendations
Sponsorship	Co-sponsorship not currently recognised outside UK.	Institution to define requirements for sole sponsorship (NB. Co-sponsorship to be recognised in new EU regulation No 536/2014).
Country selection	Resource requirements increase with each participating country.	Careful consideration of the minimum number of countries required and choices based on previous successful collaboration.
Delegation of country-specific sponsor responsibilities	Not all groups are willing or able to take on the required country-specific sponsor responsibilities.	Define detailed, accurate and clear country-specific responsibilities early in negotiations.
Insurance	Country-specific insurance requirements are complex and expensive.	Work closely with specialist insurance broker with relevant experience.
Working with North America	Regulatory, data protection and insurance requirements can be prohibitive.	Seek alternative models of collaboration to sponsoring a trial in the US e.g. run parallel trials with the same protocol and database.
Funding	Central funding is not always sufficient to cover local costs.	Highlight possible funding shortfalls to collaborative groups early in discussions and ensure all funding requirements can be met within the proposed study timelines.