Skip to Content

Data management planning

Virtual
Pricing/Discount Options: Call #2
Unique Identifier: c499b717-0caa-4670-95c5-9b2814590410

Service Description

Overview

This service empowers projects to efficiently plan and manage their data through a structured system and expert support. The system is built on the Data Stewardship Wizard (DSW), a tool developed by ELIXIR, a European life science intergovernmental organization, and operated by the SciLifeLab Data Centre. Expert data stewards provide personalized guidance, leveraging best practices and resources from the ELIXIR RDMkit and SciLifeLab’s data guidelines.

We provide expertise and technical support in the following areas:

  • A comprehensive data management planning system with ready-to-use templates.
  • Expert advice and assistance in data stewardship and management, tailored to your project’s needs.

This service ensures that your data management plan aligns with FAIR principles and established standards, promoting high-quality data practices and enabling better long-term data usability.

How can the service help you?

This service helps SMEs and research projects streamline their data management planning by providing access to a robust, user-friendly system and expert guidance. With tailored templates and best-practice guidelines, it ensures that your data management plan complies with established standards. By addressing critical aspects of data stewardship early in the project lifecycle, the service improves data quality, facilitates compliance, and enables better collaboration and long-term reuse of data, ensuring your project’s data is FAIR (Findable, Accessible, Interoperable, and Reusable).

How the service will be delivered?

The service will be delivered according to established ethical agreements and guidelines, in collaboration with the SME and researchers from the Swedish TEF-Health node.


Additional information

Provider description

The Swedish TEF-Health node is a collaboration between Karolinska Institutet, SciLifeLab and RISE, and is led by Karolinska Institutet. Together, we offer world-leading services with our unique collection of core facilities. We can grant services in expert consulting, virtual- and physical testing in the range of in vivo imaging, ex vivo OMICS, pharmaceutical development, simulated healthcare environments, AI-system validation and development, advanced data analysis and other data-driven life science.

Technical description

The service employs the DSW platform to create structured, FAIR-compliant data management plans. It provides customizable templates, enabling collaborative workflows for stakeholders. Expert guidance ensures plans meet domain-specific standards promoting data interoperability and long-term usability.

Service customization

The service can be customized according to your specific needs.


Use case example

Context

A research-focused SME is preparing to launch a multi-center clinical trial for a new biomarker discovery project. The trial will generate extensive genomic, proteomic, and clinical datasets across multiple sites. However, the SME lacks a clear and structured approach to plan how the data will be managed, shared, and stored. Without a robust data management plan, they risk non-compliance with regulatory requirements, inefficient data handling, and challenges in ensuring data interoperability and long-term usability.

Objective

To develop a comprehensive data management plan tailored to the SME’s clinical trial needs, using the DSW platform. Ensure the plan addresses data collection, storage, sharing, and long-term preservation while aligning with FAIR principles and regulatory requirements. Deliver a finalized plan that supports seamless collaboration across trial sites, enhances data quality, and ensures compliance with international standards for research data management.

Solution

The SME collaborates with the Swedish TEF-Health node to create a robust data management plan using the DSW platform. Expert data stewards guide the SME in utilizing customizable templates. The plan is developed collaboratively, addressing key areas such as data collection, metadata standards, storage solutions, and sharing protocols. Regulatory and ethical considerations, including GDPR compliance, are also incorporated. The finalized data management plan is reviewed and optimized to facilitate smooth implementation across all trial sites, ensuring scalability and long-term usability of the data.

Implementation

Ethical Agreement

The SME enters into an ethical agreement with researchers from the Swedish TEF-Health node, ensuring that all data handling comply with GDPR and Swedish national regulations.

Data Management Planning

Using the DSW platform, the SME collaborates with data stewards to develop a detailed data management plan. The plan incorporates customized templates addressing key elements.

Review and Optimization

The draft data management plan is reviewed collaboratively with stakeholders, ensuring it meets the specific requirements of the clinical trial and complies with all regulatory standards.

Benefits

  • FAIR Data Management: Enhances SMEs’ ability to manage and share clinical trial data effectively while ensuring interoperability and quality.
  • Stakeholder Credibility: A well-structured data management plan builds trust with regulators, funders, and collaborators.
  • Regulatory Compliance: Ensures adherence to ethical and legal standards, reducing data handling risks.
  • Data Sustainability: Supports long-term usability and scalability, enabling future research opportunities.

Impact

By ensuring high-quality, interoperable data, the SME builds trust with regulatory bodies, funding agencies, and research collaborators. This structured approach to data management fosters new collaborations, accelerates research outcomes, and positions the SME as a leader in clinical trial data handling. The long-term usability of their data enables broader scientific impact, enhancing their reputation and paving the way for future innovations.

Offerings: Data Processing (curation, preprocessing & standardization, mining, visualization, anonymization, FAIR, etc.) Data (FAIRness, preprocessing, standardization, best practices, etc.) Ethics & Regulatory Affairs
Provider Logo Service Logo

Provider & Contact

Provider Organisation Karolinska Institutet (KI)
Provider Country Sweden
Published Email tef-health@ki.se

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs Need and vision for data management planning
Service Outputs Data management planning software & support to create data management plans
Dependencies & Restrictions No sensitive data that falls under the ethics vote, GDPR, patientdatalag and other related regulations and laws can be stored in the software
Certification Support Service outputs (Data management plans) can be required for certification, grant and fund applications
  • Service outputs (Data management plans) can be required for certification, grant and fund applications