Writing Clinical Data Queries - Best Practices and Pitfalls 2013

Key Topics

• Investigator and site staff deliverable
  • When needed, medical input able to provide information and verify by signature approval
  • Resources to answer queries in a timely and efficient manner
  • Following resolution of all data issues, ability to respond
• Study Team deliverable
  • Communicating to the data base development specific study data needs
  • A protocol which can be easily adapted to the clinical database
  • Guidelines for queries delineating which types of data are most likely to be queried
  • Clear and effective Case Report Form (CRF) screens or booklets which result in efficient and clearly presented data presentations
  • Where answers may require explanation guidance as what kind of text should be expected
  • Queries which request as objective and direct answer as possible

Who should Attend

• Medical monitors
• Clinical research scientists
• Clinical research associates
• Data management personnel
• Quality Assurance professionals
• Clinical research coordinators
• Clinical principal investigators and co-investigators