CR sites increasingly have to make their own source documents

April 2011
Clinical Trials Administrator;Apr2011, Vol. 9 Issue 4, p42
The article highlights the fact that clinical research (CR) sites have to increasingly make their own source documents, and offers tips to create or improve the same. Cindy Mendenhall, clinical research coordinator, Evergreen Healthcare in Kirkland, Washington, suggests that CR sites should determine every documentation detail, keep synchronized clocks, check protocol events table and lab manual, add reminders and use checklists, and keep the source document material together.


Related Articles

  • Yale's QI self-assessment tool assists with better site compliance.  // Clinical Trials Administrator;Jan2011, Vol. 9 Issue 1, p9 

    No abstract available.

  • Substandard Data and Documentation Practices--Case Study #9. Pluta, Paul L.; Fields, Timothy J. // Journal of GXP Compliance;Spring2011, Vol. 15 Issue 2, p60 

    This article focuses on the validation process associated with manufacturing pharmaceutical products and medical devices. The sequence of activities involved in the process of validation are change desired, development work, validation plan, protocol, validation work, validation report,...

  • IRB has CR sites correct errors with action plans.  // IRB Advisor;Dec2011, Vol. 11 Issue 12, p123 

    No abstract available.

  • Managing CT offices: delegate and train.  // Clinical Trials Administrator;Aug2011, Vol. 9 Issue 8, p90 

    The article offers advice on how clinical trial sites can improve their management and documentation by delegating and training investigator and providing a narrative on documentation is a best practice. It also mentions that clinical research sites can develop their own quality assurance by...

  • Site-Driven Metrics. Youngquist, Laura // Applied Clinical Trials;Mar2012, Vol. 21 Issue 3, Special section p2 

    The article discusses the benefit of site-driven metrics for clinical trials industry's process improvement and site scoring. It describes the advantages of these metrics for implementing data-driven process improvements. It suggests that sites benefit from collecting operational metrics by...

  • Create tools to facilitate efficient documentation.  // Clinical Trials Administrator;Jul2011, Vol. 9 Issue 7, p77 

    The article discusses that clinical research sites should create their own coordinator tools and source documents to include information needed for compliance with research regulations in order to improve documentation efficiency. It offers information on the checklists and templates used at UT...

  • Integrate best compliance practices in CR operations.  // Clinical Trials Administrator;Nov2010, Vol. 8 Issue 11, p125 

    The article offers insights from Synergism LLC president Kelly Willenberg regarding clinical trial (CT) sites to improve compliance practices. She states that CT sites need to do system-wide risk assessments of the CT process, to find out where they need to improve policies, procedures, and...

  • Virtual IRB has quick turnaround for reviews.  // IRB Advisor;Jul2013, Vol. 13 Issue 7, p78 

    The article focuses on the newly accredited MaGil Institutional Review Board (IRB) in Rockville, Maryland. It discusses its review process timelines which include a self-imposed deadline of four hours from the time an IRB review entry is made to the time it is seen by IRB members and a...

  • Expert provides list of basic SOPs for CT sites.  // Clinical Trials Administrator;Mar2011, Vol. 9 Issue 3, p34 

    The article presents the views of Cindy Mendenhall, CCTA, clinical research coordinator, Evergreen Healthcare, Kirkland, Washington, who provides a list of basic standard operating procedures (SOPs) for clinical trial (CT) sites. Included in the list are site selection/initiation visits,...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics