Clinical Trial Agreements: A Guide to Key Words and Phrases — PDF
Negotiating a clinical trial agreement (CTA) is challenging at the best of times, but it can be a nightmare of misunderstandings, unintended commitments and accidental omissions if you don’t understand the power of the words you use.
You may reject the notion of “legalese,” but using certain words and phrases in your CTAs can help you smooth — and speed up — the process and result in an agreement that serves the interests of all parties.
Independent contractor… affiliated hospital… confidential information… party to the agreement… — are just a few of the terms you’ll encounter in developing a CTA. They may be clearly understood in everyday communication, but in a legally binding document, they have very precise meanings and can have great impact on your clinical trial if used incorrectly.
This new report gives a crash course in what you should and shouldn’t say in a CTA. It defines words and phrases in a legal context and explains what’s binding and what’s not. Clintrax attorney Eric Babineaux, a specialist in drafting and negotiating CTAs, focuses on:
- Who the real parties are, who needs to be a party and why;
- Key points that should be covered in the CTA’s preamble;
- The difference between “employee” and “independent contractor” and why it’s a vital distinction;
- How to determine if “confidential information” should be defined unilaterally or bilaterally;
- The importance of debarment provisions and how to respond to contract qualifiers on debarment certification; and
- How to interpret important indemnification provisions and understand the differences between “indemnify” and “hold harmless.”
Order your copy of Drafting Clinical Trial Agreements: Using the Right Words and Phrases. Reduce confusion and speed the negotiation of clinical trials by using clearly understood words and phrases.
Who Will Benefit
- Anyone with the responsibility of reviewing clinical trial agreements (CTAs)
- Legal counsel in small and mid-size companies
- Trial managers