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Data Quality Management In Clinical Research

DHHS/NIH/OD/OIR/OHSRP1/2/2015 The audience for this course is Principal Investigators (PIs), investigators and Research Coordinators (RCs) serving on the study team of human Clinical studies and trials. This course consists of 4 modules and a knowledge quiz. You must complete the entire course and successfully pass the quiz to obtain credit for this course at the NIH. On average this course takes 30 minutes to complete. Once you have passed the course, download and retain your completion certificate, and provide a copy to your Principal Investigator (PI) and/or Institutional Review Board (IRB) as requested Your completion record consisting of your Name, IC, and successful completion date will be retained in the OHSRP HRPP Training database: Records in this database can be viewed by the NIH community and are secured behind the NIH firewall. You have a right not to have your records included in the database, but you will be responsible for providing them upon request to your PI or IRB.

Auditing is usually conducted by regulatory agencies to confirm that requirements are being met. This type of monitoring is much less frequent and is based on regulatory requirements or concerns. Auditing can be random or for -cause. Auditing can result in a corrective action plan but it can also result in punitive action such as stopping ...

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