CDO - Compliance and Data Office

We provide guidance and support to KI’s researchers with the registrations for clinical trials and clinical studies in the different clinical trial registries, the identification of the clinical trial registry is best suited for each study or trial, the setup of accounts and registration in the ClinicalTrials.gov and CTIS registries and the reporting of results for your clinical trial in CTIS and EudraCT.

We assist the KI’s researchers in addressing the ethical considerations regarding the ethical review application. We provide advice on whether there is a need to apply for an ethical review for your research proposal, if you will need an amendment to your initial ethical approval, how to reason when choosing your responsible research principal, if you need to add participating research principals and how to fill in your ethical review application.

KI is the host for the Data Science Node (DSN) within Precision Medicine & Diagnostics (PMD), part of the SciLifeLab & Wallenberg National Program for Data-Driven Life Science. The DSN provides research support within data management systems and services, as well as project-specific bioinformatic support connected to WABI at NBIS.

The CDO also manages the internal KI grants and awards calls and is responsible for the organizational account in Prisma. 

We provide KI's researchers with advice and support regarding

• the research data management including collection, storage, analysis, sharing & archiving
• the review of the data management plans for externally financed projects
• the implementation of the KI REDCap for data collection
• the personal data handling and GDPR compliance. 

In collaboration with the KI legal team, we are managing cases where personal data are transferred between parties. We review the cases from the compliance perspective e.g. ethics, and existing contracts and assess the responsibilities of the parties regarding personal data e.g. data processor, independent data controller, and joint controllers. We are also responsible for the provision of suitable agreement templates. 

Contact: Research Data Office rdo@ki.se 

The Electronic Logbook (ELN) is the platform of choice for electronic research documentation at KI. It is mandatory for KI researchers to document their research electronically using the ELN. 

The ELN coordinators team provides guidance and support to the group leaders, the KI ELN users, and superusers, either by managing individual inquiries or by holding ELN workshops after request. The team is also responsible for providing up-to-date information, guides, manuals, and demos.  

Contact: ELN elnkoordinator@ki.se

We are responsible for managing the following systems the KI researchers broadly use. 
CFM/iLab  Core facility management system specifically designed for the needs and workflows of core facilities.
DMPOnline  System for data management plans.
iThenticate Plagiarism detection system. 
KI ELN Electronic research documentation system, replacing paper research logbooks and lab notebooks.  
Pivot-RP Database for finding global funding opportunities.
Prisma Funding calls and application portal. 
REDCap System is used to build and manage surveys and forms to collect and analyze data.

The US compliance team is responsible for coordinating the US funded research projects, awarded to the KI researchers. As US compliance specialists we assure compliance with the US, EU, and Swedish legal requirements.

• Project management: we are responsible for the contract management of US federal awards, financial review, reporting, and auditing. 
• Ethics: we provide support with the ethical submission phase and development of patient information to meet the KI compliance requirements.
• Nonfinancial compliance: CDO keeps KI registration in federal US systems required to apply for grants and reporting up to date. We also report to the US Office of Research Integrity per NIH requirements on research misconduct or suspected research misconduct.   
• KI Institutional Review Board (IRB) is managed by the CDO in terms of suggesting members, meeting management, and registrations.

Contact: US compliance compliance@ki.se 

Meet our team and find contact information for our team members. 

Address: Karolinska Institutet
Compliance & Data Office
171 77 Stockholm

Visiting address: Nobels väg 15A, Solna