Centralization of clinical trial registration & reporting

Karolinska Institutet (KI) has centralized the registration and results reporting process for clinical trials and clinical studies. KI provides specific information and procedures, based on regulations and requirements, to support researchers to efficiently register, update and report results in clinical trial registries.

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The Compliance & Data Office (CDO) has developed detailed strategies and procedures for implementing the centralization of clinical trial registration and reporting. Specific facets in the workplan include, among other things, the development of a database with Karolinska Institutet (KI) registered clinical trials and clinical studies, establishing a Protocol Registration and Results System (PRS) Administrator account for ClinicalTrials.gov, a Primary Account for EudraCT and a ’High-Level Administrator’ account for CTIS, developing networks to increase national and international collaboration, and monitoring deadlines for required updates and reporting results for clinical trials and clinical studies registered in these respective clinical trial registries.

In this initial phase, only ClinicalTrials.gov and EudraCT databases are included, as most KI clinical trials and clinical studies are registered in these two respective clinical trial registries. This means that accounts that are registered with KI as the Research Principal/Sponsor will now be tied to a central PRS Administrator account in ClinicalTrials.gov, and a central Primary Account in EudraCT, to which both will be maintained by CDO. Through the role as a PRS Administrator at ClinicalTrials.gov, CDO can assist researchers with many issues, including gaining access to information about the clinical study; creating new user accounts; assistance in registration and reporting: and reviewing for errors, required updates, and unreported results. In EudraCT, the KI Primary Account is limited to reporting clinical trial results only, however, CDO can provide researchers with support for that task.

From 31 January 2022, new clinical trials conducted within EU will be registered in CTIS instead of EudraCT. Work is in progress to produce information about this on Medarbetarportalen. Information and procedures regarding centralization are accessible by downloading "KI’s Clinical Trial Registration & Reporting (CTRR) Instructions" document using the link below. With questions concerning the centralization process at KI, please contact CDO at compliance@ki.se.

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