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Data Monitoring Committees: Current issues [PDF]

Clinical Trials, 2018
Maintaining confidentiality of emerging data and ensuring the independence of Data Monitoring Committees are best practices of considerable importance to the ability of these committees to achieve their mission of safeguarding the interests of study participants and enhancing the integrity and credibility of clinical trials.
Thomas R Fleming, Susan S Ellenberg, David L DeMets   +2 more
openaire   +2 more sources

Investigasi Empiris: Tata Kelola Perusahaan dan Pengungkapan Sukarela pada Perbankan Syariah di Indonesia

Equilibrium: Jurnal Ekonomi Syariah, 2020
This study investigated empirically the effect of good corporate governance on the level of voluntary disclosure in annual reports of Islamic banks.
Siti Rokhaniyah
doaj   +1 more source

Impact of audit committee characteristics on firm performance: Evidence from Bahrain [PDF]

Problems and Perspectives in Management, 2022
The purpose of this study is to analyze the relationship between different audit committee attributes and company performance in Bahrain. This paper investigates the impact of audit committee independence, size, and meeting frequency on company ...
Abdulla Al-Jalahma
doaj   +1 more source

Standard 3: Data Monitoring Committees

Pediatrics, 2012
* Abbreviations: DMC — : data monitoring committee Children are generally regarded as “vulnerable individuals.” There has long been reluctance to perform research in children except in limited settings such as pediatric cancer and vaccine development.
Ellenberg, S, Fernandes, R, Saloojee, H, Bassler, D, Askie, L, Vandermeer, B, Offringa, M, Van der Tweel, I, Altman, D, van der Lee, J   +9 more
openaire   +6 more sources

A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials

Trials, 2017
Background The DAMOCLES project established a widely used Data Monitoring Committee (DMC) Charter for randomised controlled trials (RCTs). Typically, within the UK, the DMC is advisory and recommends to another executive body; the Trial Steering ...
Elizabeth J. Conroy, Barbara Arch, Nicola L. Harman, J. Athene Lane, Steff C. Lewis, John Norrie, Matthew R. Sydes, Carrol Gamble   +7 more
doaj   +1 more source

Challenges to Data Monitoring Committees When Regulatory Authorities Intervene. [PDF]

, 2016
New pharmaceutical agents are best evaluated in randomized, controlled clinical trials in which both the safety of participants and the adequacy of conduct are monitored by an independent data monitoring committee as described in reports from regulatory ...
Borer, Jeffrey S, Pitt, Bertram, Pocock, Stuart, Rouleau, Jean, Swedberg, Karl   +4 more
core   +1 more source

Impacts of Audit Committee characteristics on Firms Risk [PDF]

مجله دانش حسابداری, 2018
Audit committee is one of the corporate governance mechanisms, and there is little evidence in its role and characteristics in risk monitoring and governance in companies.
Alireza Kian (Ph.D), Mohsen Faghih
doaj   +1 more source

Continuous low-dose antibiotic prophylaxis for adults with repeated urinary tract infections (AnTIC): a randomised, open-label trial [PDF]

, 2018
Funder: UK National Institute for Health Research. Open Access funded by Department of Health UK Acknowledgments We thank all the participants for their commitment to the study, Sheila Wallace for updating the systematic review, members of the Trial ...
Abdel-Fattah, Mohamed, Brennand, Catherine, Chadwick, Thomas, Fader, Mandy, Fisher, Holly, Harrison, Simon, Hilton, Paul, Larcombe, James, Little, Paul, McClurg, Doreen, McColl, Elaine, N’Dow, James, Oluboyede, Yemi, Pickard, Robert, Ternent, Laura, Thiruchelvam, Nikesh, Timoney, Anthony, Vale, Luke, von Wilamowitz-Moellendorff, Alexander, Walton, Katherine, Wilkinson, Jennifer, Wood, Ruth   +21 more
core   +2 more sources

The value of source data verification in a cancer clinical trial [PDF]

, 2012
Background Source data verification (SDV) is a resource intensive method of quality assurance frequently used in clinical trials. There is no empirical evidence to suggest that SDV would impact on comparative treatment effect results from a clinical ...
AS Therasse P, BW Morrison, C Baigent, Catrin Tudur Smith, David Cunningham, Deborah D. Stocken, EL Eisenstein, GS Buyse M, JA Lane, Janet Dunn, JL Lienard, John P. Neoptolemos, Paula Ghaneh, S Funning, Salomon M. Stemmer, Trevor Cox, VJ Favalli G   +16 more
core   +2 more sources

Exploring factors associated with views on sharing of certain interim trial result measures by the data safety monitoring board (DSMB) with non-DSMB members

Trials, 2018
Background Sharing interim result measures by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an important issue that can affect trial integrity.
Victoria Borg Debono, Lawrence Mbuagbaw, James Paul, Norman Buckley, Lehana Thabane   +4 more
doaj   +1 more source