Clinical trial transparency at Karolinska Institutet
Registering and reporting results for clinical trials and clinical studies are vital measures for ensuring clinical trial transparency. Karolinska Institutet (KI) is committed to improving clinical trial transparency for the innovative research conducted at the University.
Clinical trial transparency is defined as the sharing and use of clinical data across global registries. Greater clinical trial transparency leads to improved patient and medical care, spurs scientific innovation, and produces overall better healthcare systems. Unfortunately, a growing number of clinical trials and clinical studies are registered either incorrectly or incomplete. With 83% of European Universities failing to report their results in clinical trial registries, a collaborated effort has been initiated in Europe to increase the transparency and accessibility of clinical data within open science. It is, therefore, imperative that researchers at Karolinska Institutet (KI) register, update and report results in an approved clinical trial registry in accordance with national and international regulations and procedures.
Karolinska Institutet is committed to making information about the clinical research conducted at KI both visible and accessible. In an effort to improve clinical trial transparency within open science, the University Director has issued a new initiative to centralize the clinical trial registration and reporting process at KI. This task has been bestowed to the Compliance and Data Office (CDO) within the Research Support Office (RSO) at KI. Information regarding the centralization process of registration and reporting at KI can be accessed at the "Centralization of clinical trial registration & reporting" webpage.
CDO has developed comprehensive procedures to support researchers in registering, updating, and reporting results in clinical trial registries. These measures are designed to assist researchers by providing relevant information and support to effectively register and report results in namely ClinicalTrials.gov, CTIS and EudraCT. Regulatory information and procedures for registration and reporting are available by downloading "KI's Clinical Trial Registration & Reporting (CTRR) Instructions" document using the link below.