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conferenceseries
.com
Volume 7, Issue 5 (Suppl)
J Clin Trials, an open access journal
ISSN:2167-0870
Clinical Trials 2017
September 11-13, 2017
September 11-13, 2017 San Antonio, USA
4
th
International Conference on
Cl inical Tr ial s
Management of clinical trial agreements
JoAnn Pfeiffer
Arizona State University, USA
C
lincal 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.
Biography
JoAnn Pfeiffer has completed her Doctorate of Science, in Regulatory Science from the University of Southern California. She is currently the Director and an
Associate Professor, in the Clinical Research Managment Graduate Program at Arizona State University. She has published several books related to managing
contracts and budgets in clinical trials, conducting clinical trials at study sites, as well as articles in peer reviewed journals. Her expereince includes over 20 years
in the management of clinical trial operations in both academic and non-academic settings.
jpfeiff4@asu.eduJoAnn Pfeiffer, J Clin Trials 2017, 7:5 (Suppl)
DOI: 10.4172/2167-0870-C1-019