Biography
Biography: Joann Pfeiffer
Abstract
Clincal trial agreements are legal and binding, forming the foundation for a successful partnership between study sites and sponsors. Not understanding the legal language and the terms of the contract can lead to financial and legal ramifications for the site, the investigator, and study staff. Terms and language of the contract will be reviewed focusing on risk areas and protecting the site. Through interactive activities participants will review and revise contract language to meet the needs of the site. Proper management of contracts includes knowing what you are agreeing to, prioritizing site needs, and utilizing site metrics and successful strategies to negotiate a fair and balanded contract. Strategies include redlining contracts with preferred language, naming and version control, reviewing related study documents for consistency, contract definitions, addressing the responsibilities of the contract parties, and asking questions for clarification. The session will finish with contract tips.