External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial [PDF]
Contemporary Clinical Trials Communications, 2017 The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial.
Sheila M. Bird +7 more
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Liability issues for data monitoring committee members [PDF]
Clinical Trials, 2004 In randomized clinical trials, a data monitoring committee (DMC) is often appointed to review interim data to determine whether there is early convincing evidence of intervention benefit, lack of benefit or harm to study participants. Because DMCs bear serious responsibility for participant safety, their members may be legally liable for their actions.
DeMets, David L +9 more
openaire +4 more sources
Shedding light on data monitoring committee charters on ClinicalTrials.gov. [PDF]
Clin Trials, 2023 Fine AM, Golfinopoulos E, Tse T.
europepmc +2 more sources
Establishing a data monitoring committee for clinical trials. [PDF]
Shanghai Arch Psychiatry, 2014 A data monitoring committee (DMC) is a group of clinicians and biostatisticians appointed by study sponsors who provide independent assessment of the safety, scientific validity and integrity of clinical trials. In the United States, the Food and Drug Administration requires the formation of DMC in all trials that assess new interventions. DMC are also
Lin JY, Lu Y.
europepmc +3 more sources
Issues in regulatory guidelines for data monitoring committees [PDF]
Clinical Trials, 2004 As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials.
DeMets, David +18 more
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The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias [PDF]
BMC Medical Research Methodology, 2008 Background Interim analysis of accumulating trial data is important to protect participant safety during randomized controlled trials (RCTs). Data Monitoring Committees (DMCs) often undertake such analyses, but their widening role may lead to extended ...
Hampton John +3 more
doaj +2 more sources
[Data monitoring committees-state of the art and perspectives for the future]. [PDF]
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz, 2020 Fischer T.
europepmc +3 more sources
Independent data monitoring committees: An update and overview [PDF]
Urologic Oncology: Seminars and Original Investigations, 2015 An independent data monitoring committee׳s (IDMC's) duty is to ensure that the interests of the patients entered in the trial are being well served (i.e., the risk-benefit ratio is appropriate) and that the scientific integrity of the trial is maintained during the interim between trial initiation and trial completion.
Oliver, Sartor, Susan, Halabi
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THE INFLUENCE OF BOARD OF COMMISSIONERS AND AUDIT COMMITTEE EFFECTIVENESS, OWNERSHIP STRUCTURE, BANK MONITORING, AND FIRM LIFE CYCLE ON ACCOUNTING FRAUD [PDF]
Jurnal Akuntansi dan Keuangan Indonesia, 2013 Financial statement fraud has cost market participants, including investors, employees, creditors, and pensioners. Capital market participants expect active and vigilant corporate governance to ensure the quality, integrity, and transparency of financial
Synthia Madya Kusumawati +1 more
doaj +6 more sources
Experiences of the Data Monitoring Committee for the RECOVERY trial, a large-scale adaptive platform randomised trial of treatments for patients hospitalised with COVID-19. [PDF]
Trials, 2022 Sandercock PAG +9 more
europepmc +3 more sources