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Compliance & Data Office

The Compliance & Data Office (CDO) provides researchers with support, advice, and guidance for the research documentation, data management, US compliance, clinical trials management and support, and system management, Data Science Node.

The Compliance and Data Office (CDO) provides researchers with support, advice, and guidance for research documentation, data management, KI research grants & awards, US compliance, clinical trials management and support, system management, and Data Science Node.

The CDO鈥檚 international multidisciplinary team combines multiple academic backgrounds with professional experiences from academia, healthcare, and industry. CDO offers a wide range of professional services within several domains described in the "what we do" tab.   

Cecilia Martinsson Bj枚rkdahl leads the work within CDO and coordinates the Research Data Office (RDO). Together, the CDO and RDO offices provide broad support to the KI researchers throughout their whole research process. 

Compliance
Photo: GettyImages.

What we do

Clinical Trials Management

We provide guidance and support to KI鈥檚 researchers with the 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鈥檚 researchers in addressing the ethical considerations regarding the . 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.

Data Science Node

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 .

KI research grants & awards

The CDO also manages the internal calls and is responsible for the organizational account in . 

Research Data Management

We provide KI's researchers with advice and support regarding

  • the including collection, storage, analysis, sharing & archiving
  • the review of the for externally financed projects
  • the implementation of the for data collection
  • the 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 

Research Documentation

The 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

System Management

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

US compliance

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.

  • : we are responsible for the contract management of US federal awards, financial review, reporting, and auditing.
  • : we provide support with the ethical submission phase and development of patient information to meet the KI compliance requirements.
  • : 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 is managed by the CDO in terms of suggesting members, meeting management, and registrations.

Contact: compliance@ki.se 

Staff and contact

Head of unit

All members of the group