Common use of Publication of Study Results Clause in Contracts

Publication of Study Results. GSK represents that it generally seeks publication of the results of all GSK-Sponsored interventional Research in peer-reviewed, searchable journals and imposes specified timeframes for the drafting and submission of manuscripts following completion of a study. For purposes of these publication requirements, GSK’s publication policy includes certain GSK-Sponsored observational Research studies and certain GSK-Sponsored meta-analyses and pooled analyses. In addition, GSK represents that it has established policies and “operating practices” governing scientific engagement, which included detailed directions regarding publications. Among other things, the operating practices require the implementation of data dissemination plans that establish prospective publication strategies for GSK-Sponsored Research and address requirements for appropriateness, accuracy, and balance in publications of GSK-Sponsored Research. In all publications about GSK- Sponsored Research, GSK shall acknowledge its role as the funding source. In addition, GSK represents that it has established policies, systems, and practices designed to ensure that adverse event data is properly reported to the FDA. In addition, GSK requires investigators to report study-related information and data, GlaxoSmithKline LLC Corporate Integrity Agreement including data about adverse events before receiving final payment from GSK. The standards, policies, and practices described above shall hereafter be referred to collectively as the “Research and Publication Practices.” GSK shall maintain its Research and Publication Practices (or standards and practices substantially equivalent to those set forth above) for studies initiated or completed after the Effective Date for the term of the CIA. To the extent that GSK intends to materially change these Research and Publication Practices, it shall notify the OIG about the change 30 days in advance of the effective date of the change;