Last week, Clinical Conductor CTMS hosted a webinar with Marilyn Windschiegl, Clinical Research Contracts and Compliance Director at PharmaSeek, to discuss the current trends in contract negotiation. She discussed how reviewing and negotiating clinical trial agreements (CTAs) with sponsors can be a complicated endeavor, but gave listeners the tools they need to make those negotiations highly beneficial to a research site.
The webinar began by discussing why research sites should even bother with negotiating their contracts. Marilyn points out that negotiation is key before you can open a study, but they are also a common cause of delay during the study set-up phase. This is due to inefficient and ineffective negotiations, which can lead to several problems throughout the study. Marilyn went on to say that correctly negotiating these contracts will offer research sites protection against manageable risks, provide clear understanding of what is agreed to and what the site is being paid to do, and clarifies the lines of authority and responsibility.
Party structure and indemnification are two of the trends discussed during the webinar. The question with party structure comes down to who should be a party? Marilyn suggests that there should be more three party agreements, such as when certain services are rendered off site, or when an investigator is contracted rather than employed. She also discussed indemnification and the reasons why a research site would be interested in it. From a sponsor’s failure to comply with applicable FDA or governmental regulations, or a subject failing ill as a result of participating in a study, research site want to know who would be liable. Sponsors are also interested in indemnification when a site has been negligent while performing a study, or if there is a breach of the site’s obligations under the agreement.
Another trend that Marilyn touched on was confidentiality. Sponsors usually want to protect as much about the study as possible, and sites typically want to protect the intellectual property owned before the study. Sites also want to protect the subject’s personal health information, informed consents and authorizations.
One of the last industry trends discussed during the webinar was record retention. Digital storage is considered less expensive than paper records storage; however, Marilyn states that it must remain accessible for the duration of the period it is retained. Digital storage should be financially supported by the research site to retain these records beyond the time of its standard retention period. Marilyn stressed that whenever possible, establish that the study records will be returned to the sponsor at the time the site’s retention period expires – at the sponsor’s expense.
In closing, Marilyn discussed best practices moving forward with contract negotiations. She reminded listeners to know your requirements; will they cause negotiations to take longer? She also mentioned to always have documentation ready, and create standardized documentation that can be provided to the sponsor supporting your request. Finally, Marilyn told listeners to know your non-negotiables and expectations, and reminded them about being patient with a sponsor or CRO.
Interested in learning more about the current trends in contract negotiations? Click here to listen to the entire webinar featuring Marilyn Windschiegl!
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