Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies
Schlaff WD, Zhang H, Diamond MP, Coutifaris C, Casson PR, Brzyski RG, Christman GM, Barnhart KT, Trussell JC, Krawetz SA, Snyder PJ, Ohl D, Santoro N, Eisenberg E, Huang H, Legro RS, Network R. Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies. Fertility And Sterility 2011, 96: 15-18. PMID: 21645894, PMCID: PMC3151556, DOI: 10.1016/j.fertnstert.2011.05.069.Peer-Reviewed Original ResearchConceptsPolycystic Ovary Syndrome IReproductive Medicine NetworkMulticenter clinical trialMulticenter trialClinical trialsSubstantial burdenInstitutional reviewClinical investigatorsMedicine NetworkSignificant increaseBurdenTrialsInstitutional review board requirementsObjective dataIRB submissionPregnancyInfertilityHuman research participantsYearsSignificant variability