Local Ethic Committees (LECs) and their approach to Site Contracts/Budgets is another point of interest for the Contract Negotiator.

Some of the public sites participating in clinical trials, usually university hospitals, have their own process of vetting a clinical study. They analyse the study documentation, including contract and budget proposals in internal Ethics Committees. These ECs meet once or twice per month and they review pre-required documentation in order to approve the study for the sites selected for participation already by the Sponsor or Sponsor’s designee.

The contract and budget proposals from Sponsor often play a key role in the Local Ethics Committee evaluation as the Institution representatives are keen to know about the budget proposal, cover their site specific and start-up fees, at times, if the budget is being split between Institution and the study team, verify the percentage PI directs to the hospital.

When it comes to the contract, the legal department of the university site very often revises the contract after the LEC approves the budget and a template and if anything is flagged by the Committee it will be incorporated in the review of the contract template from the Institution/site.

Other aspects of interest for the Committee is the patient reimbursement and connected aspects (including meal, overnight stay, travel etc.). LECs will also review the patient documentation package but the budget allocated to this end is a relevant information, as the handling of the process might be done via the Institution, if not taken over by a vendor.

However, we note the level of LECs’ interest in contract/budget varies from country to country and even from site to site within the same country. With few exceptions, if we go from the West to the East of Europe, we see the tendency of reducing interest of LECs in site contracts/budgets. For instance, Russia which is the Eastern edge of Europe – LECs in that country are generally not interested in contracts/budgets as such.

Thus, this is essential for the negotiator to know LECs’ approach and their role in contract/budget review and negotiation to mitigate the risk of contract being a bottleneck for study initiation in a particular site or in a country in general.