Clinical Trials Administrator Archives – April 1, 2011
April 1, 2011
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Compliance Best Practices Research institute establishes best practices in preventing trial mistakes
Research institutions need a best practice plan for preventing and handling regulatory issues whether they have 50 or 500 new studies a year. -
Research institutions face exorbitant fines if accidentally release PHI
Medical and research institutions have a great deal more to fear these days from aninadvertent release of protected health information (PHI). -
CR sites increasingly have to make their own source documents
Clinical study sites are carrying a greater part of the compliance burden these days as sponsors increasingly are shifting responsibilities their way such as the task of making source documents, an expert says. -
Avoid these common budget missteps with new studies
Clinical trial (CT) sites and principal investigators can improve their budget cash flow by spending more upfront time on the budgeting process before signing contracts with sponsors. -
Master documents, 'score cards' are latest trends in trial contracts
Sponsor-initiated clinical trial agreements are well-worn pathways, so it makes sense that the latest trend of recent years is for research sponsors and research institutions to use master agreements. -
Subject injury program reduces claims costs at research institution
Research institutions often lack policies and programs to deal with research participants' injuries. This neglected area of concern could prove problematic when injuries occur and result in litigation.