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Independent oversight of trial activities is provided by a Data and Safety Monitoring Board appointed by the NIDCR.
Study safety was monitored by an independent data and safety monitoring committee, which maintained oversight of trial conduct, patient safety and the two planned interim analyses.
GJM, KTP, DC, KWB, KB, PM, AM were co-applicants on the original funding application, contributed to the overall design of the trial and are jointly responsible for oversight of trial conduct.
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Oversight of the trial included a trial management group and independent trial steering and data monitoring committees.
We thank members of the independent data monitoring committee (Jeff Evans, Emma Hall, and Ruth Plummer) and the independent trial steering committee (Barry Hancock, John Wagstaff, and Stephen Shepherd) for their oversight of the trial.
During this period, the oversight of clinical trial safety has shifted from academic medical institutions to commercial firms like Coast.
Penn has already acknowledged "weaknesses" in its oversight of the trial, but says they "did not contribute to Jesse's death".
We also thank the volunteers for their personal sacrifices, and the NIAID Data and Safety Monitoring Board and Institutional Review Boards for their judgment and oversight of the trial.
NG, SLN, HC, BN and IBH are jointly responsible for the academic oversight of the trial and all authors were involved in revising the manuscript and gave final approval for publication.
In a letter to Snyderman released on 14 May, OPRR enforcement officer Michael Carome writes that Duke must submit a complete list in 2 weeks of all trials that were suspended and, after that, file quarterly reports on its progress in improving the oversight of clinical trials.
In addition to ethics committees with oversight of clinical trials, recombinant DNA technology research is overseen by Institutional Biosafety Committees (IBCs).
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