Published on in Vol 2, No 2 (2016): Jul-Dec

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project

Journals

  1. Levit L, Perez R, Smith D, Schilsky R, Hayes D, Vose J. Streamlining Adverse Events Reporting in Oncology: An American Society of Clinical Oncology Research Statement. Journal of Clinical Oncology 2018;36(6):617 View
  2. Corneli A, Hallinan Z, Hamre G, Perry B, Goldsack J, Calvert S, Forrest A. The Clinical Trials Transformation Initiative: Methodology supporting the mission. Clinical Trials 2018;15(1_suppl):13 View
  3. Park Y, Koo H, Yoon Y, Park S, Lim Y, Baek S, Kim H, Kim T. Expedited Safety Reporting to Sponsors Through the Implementation of an Alert System for Clinical Trial Management at an Academic Medical Center: Retrospective Design Study. JMIR Medical Informatics 2020;8(2):e14379 View
  4. Riordan D, Kinane M, Walsh K, Shiely F, Eustace J, Bermingham M. Stakeholders’ knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study. European Journal of Clinical Pharmacology 2020;76(10):1363 View
  5. Margas W, Wojciechowski P, Toumi M. Impact of the COVID-19 pandemic on the conduct of clinical trials: a quantitative analysis. Journal of Market Access & Health Policy 2022;10(1) View
  6. Boutzoukas A, Olson R, Sellers M, Fischer G, Hornik C, Alibrahim O, Iheagwara K, Abulebda K, Bass A, Irby K, Subbaswamy A, Zivick E, Sweney J, Stormorken A, Barker E, Lutfi R, McCrory M, Costello J, Ackerman K, Munoz Pareja J, Dean J, Abdelsamad N, Hanley D, Mould W, Lane K, Stroud M, Feger B, Greenberg R, Smith P, Benjamin D, Hornik C, Zimmerman K, Becker M. Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience. Contemporary Clinical Trials 2023;125:107067 View