Common use of Clinical Trial Agreements Clause in Contracts

Clinical Trial Agreements. For sites who have participated in the previous study these agreements will be used as the basis for the new study agreement, decreasing the need for negotiation, which will facilitate the execution process. If new sites will be initiated these agreements will serve as a template for the new agreements. Activities include: • Create all clinical study agreements templates and patient budget template with the Sponsor • When possible, set up pre-approved alternative language and budget parameters in anticipation of negotiation • Negotiate all clinical study agreements that satisfy Sponsor requirements on behalf of the Sponsor • Incorporate changes using pre-approved alternative parameters and if changes are outside parameters, secure approval by the Sponsor • Obtain signatures from investigators, institutions, facilities, on all clinical study agreements as needed • Collect IRS Form W9 and payment information forms from sites • Track documentation and communication with the sites, Omnicare CR Project Management and the Sponsor.