Course Description

Negotiating EU Clinical Investigation Agreements

Course Description:

For clinical project managers, nothing says “lost time and energy” better than liaising between legal departments over investigation agreements. And just as hospitals enjoy talking with lawyers about as much as lawyers enjoy conversing with hospitals - it is imperative that clinical project managers possess a solid hand in negotiating effective clinical investigation agreements to get the job done quickly and in scope.
This richly detailed course on “Negotiating EU Clinical Investigation Agreements” will give you the recommendations, options and expert insight on how to better negotiate clinical investigation agreements by addressing the most common problematic sections of any contract.
From the basic elements of a contract including responsibilities and duties of each party, to insurances, indemnifications, publication and property rights; you’ll learn the inside-out of what it takes to negotiate like a pro.

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Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully negotiate the most common problematic sections in a clinical investigation agreement, including;

  • Basic elements of the contract
  • Responsibilities concerning all parties involved
  • Insurances and indemnifications
  • Publication and Property rights.

Who Should Enroll:

Clinical Project Managers, Clinical Project Directors, Sales and Marketing managers who are likely to be involved in the process, clinical investigators, staff of the hospital administration likely to be involved in contract review.

Prerequisite Knowledge/Requirements:

Understand basics of GCP as outlined in ID 42 and an in depth understanding of the contents of ISO 14155:2011 as outlined in course ID 68. Experience with managing clinical investigations is essential to start this process preferably all skills of the project manager as outlined in the suite of courses ID 95General knowledge of the content of a clinical investigation agreement as outlined in course on Understanding EU Clinical Investigation Agreements (ID 111).

Subject Matter Expert:
Daniela Schmidt

40 min

Related resources:

Case studies:

Basic Account: € 122.00
Premium Account: € 91.00

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