This course is designed to provide you with an insight in the management of study contracts, the basics of the legal requirements regarding clinical studies that need to be captured in a study contract, and the structure and main provisions of study contracts. You will receive hints and tricks on understanding and negotiating specific study contract provisions.
This 1-day course provides essential information about the management and negotiation of study contracts. The basics of the legal requirements for studies in Europe that need to be captured in study contracts, the structure of a study contract as well as the practical handling of the contractual documents are presented based of a model contract and/or model provisions.
Furthermore, the understanding and negotiating of specific study contract provisions are reviewed and discussed.
Here's a link for more info about the Histories, Policies and Laws from Clinicaltrials.gov