• Failure to Report: A STAT Investigation on

    • 12.15.2015

    Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found. The violations have left gaping holes in a federal database […]

  • CT.Gov Offers New Individualized Training to Investigators for Results Module

    • 06.22.2015

    ClinicalTrials.Gov is piloting a process to provide one-on-one assistance for investigators throughout the results submission process.  As part of the process, a member of the ClinicalTrials.Gov results team will be available to help prepare you for results submission, orient you to the PRS (Protocol Registration and Results System), and walk you through the data entry […]

  • Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

    • 05.28.2015

    Reliable approaches to monitoring are critical, and although a variety of monitoring approaches are available for overseeing clinical trial conduct, the most common approach remains frequent visits to each clinical trial site. During the past two decades, there has been a dramatic global increase in the number and complexity of clinical trials. In 2013, the […]

  • GCPartner App Now Available

    • 05.28.2015

    The new GCPartner app is now the must have app for all researchers involved in Good Clinical Practices (GCPs).    Have the  GCP’s at your finger tips no matter where you are at.  For more information on how to get this free app click here…..

  • WHO calls for increased transparency in medical research

    • 04.20.2015

    WHO today issued a public statement calling for the disclosure of results from clinical trials for medical products, whatever the result. The move aims to ensure that decisions related to the safety and efficacy of vaccines, drugs and medical devices for use by populations are supported by the best available evidence.  Click here to read […]

  • 23 Million Hours Spent Each Year Complying With Clinical Trial Requirements, FDA Estimates

    • 03.4.2015

    Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year.

  • Comment Period Extended for NPRM on ClinicalTrials.Gov

    • 02.12.2015

    The Department of Health and Human Services (HHS) is extending the public comment period for the Notice of Proposed Rulemaking (NPRM) on Clinical Trials Registration and Results Submission. The proposed rule was published on November 21, 2014 (79 FR 69566) with a deadline for public comments of February 19, 2015. The comment period is being […]

  • FDA Issues Guidance on Laboratory Developed Tests (LDT’s)

    • 02.12.2015

    Laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. […]

  • NIH Issues NPRM for ClinicalTrials.Gov

    • 02.11.2015

    In late November 2014, the National Institutes of Health issued the Notice of Proposed Rule Making (NPRM) and a revised NIH policy regarding the ClinicalTrials.Gov database