Jan 16
Triage and Initial Assessment: An additional triage is typically done at this point to ensure the case is processed according to the proper timeline and under the appropriate reporting rules, making sure the case then flows through the appropriate workflow. Typically based on factors such as death or life-threatening events, case seriousness, country-specific reporting timelines, association (relatedness), and/or expectedness.
In 2020:
60% of respondents were applying at least some level of automation.
40% of respondents reported no automation of this ICSR process step.
In 2021:
67% of respondents were applying at least some automation.
33% of respondents reported no automation of this ICSR process step.
Related Blog Posts
The Impact of ICH E6(R3) – Sponsor and CRO Perspectives
In ACRO and TransCelerate BioPharma’s latest collaboration, Cris McDavid (Senior Director, Global Clinical Operations, Parexel) and Tashan Mistree (Senior Director, Business Operations, Office of Chief Medical Officer, GSK) join this week’s episode to discuss the impact of ICH E6(R3) from their different vantage points in the clinical research industry. Listen to the podcast by Cris McDavid and Tashan Mistree…
Unifying Industry to Better Understand GCP Guidance
In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate…
Closing the Evidence Gap in Women’s Health – the Need for Inclusive Clinical Research
For decades, women were significantly underrepresented in clinical trials. Recent years have seen improvement, but there are lingering gaps in our collective understanding of how therapies work across sexes, life stages, health conditions and care settings. Read the full article by Jeneen Donadeo from PharmaTimes here.