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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.

corrective action plan but it can also result in punitive action such as stopping research or in a worse-case scenario, debarment of the PI. What you need to know: The NIH Human Research Protection Program (HRPP) and ICs ... (QI) methodology. Below is a list of regulations, policy and guidance regarding data quality management: ...

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Guiding Principles for Data Management - Nih

oir.nih.gov

Guiding Principles for Data Management The proper management, interpretation, and representation of scientific data are central to all scientific inquiry. A wide range of scientific approaches are incorporated into the research carried out at the NIH, but two guiding

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SCIENTIFIC RECORD KEEPING - Nih

oir.nih.gov

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Conduct of Research - Nih

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4 Sections marked by an asterisk (*) indicate policy statements. Mentoring and the Responsibilities of Research Supervisors and Trainees Research training is a complex process, the central aspect of which is a period of research carried out

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Guidelines for Human Biospecimen - NIH Office of ...

oir.nih.gov

These guidelines provide information on the ethical storage, tracking, sharing, and disposal of human biospecimens within the IRP. There are many important regulations and policies on the ethical acquisition of human biospecimens, summarized in the Guidelines and Policies for the Co nduct of Research in the Intramural

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