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Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials.
Pechero G Jr, Pfaff B, Rao M, Pogorzelski D, McKay P, Spicer E, Howe A, Demyanovich HK, Sietsema DL, McTague MF, Ramsey L, Holden M, Rudnicki J, Wells J, Medeiros M, Slobogean GP, Sprague S; PREP-IT Investigators; Slobogean GP, Sprague S, Wells J, Bhandari M; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; PREP-IT Clinical Sites; O'Toole RV, D'Alleyrand JC, Eglseder A, Johnson A, Langhammer C, Lebrun C, Manson T, Nascone J, Paryavi E, Pensy R, Pollak A, Sciadini M, Slobogean GP, Degani Y, Demyanovich HK, Howe A, O'Hara NN, Joseph K, Rudnicki J, Camara M; Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE. Pechero G Jr, et al. Contemp Clin Trials Commun. 2021 Jun 14;22:100787. doi: 10.1016/j.conctc.2021.100787. eCollection 2021 Jun. Contemp Clin Trials Commun. 2021. PMID: 34195467 Free PMC article.
Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial.
Pogorzelski D, Nguyen U, McKay P, Thabane L, Camara M, Ramsey L, Seymour R, Goodman JB, McGee S, Fraifogl J, Hudgins A, Tanner SL, Bhandari M, Slobogean GP, Sprague S; PREP-IT Investigators Executive Committee:; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; McMaster University Methods Center; University of Maryland School of Medicine Administrative Center; University of Maryland School of Pharmacy, The PATIENTS Program; PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE); Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE; PREP-IT Investigators Executive Committee. Pogorzelski D, et al. Contemp Clin Trials Commun. 2021 Jan 23;21:100730. doi: 10.1016/j.conctc.2021.100730. eCollection 2021 Mar. Contemp Clin Trials Commun. 2021. PMID: 33605946 Free PMC article.