• An Africa-led, public-private supported network

• The CTC platform as a cornerstone for the future network

• Mapping of existing subnetworks and infectious diseases epidemiology data

• Shaping the network’s ecosystem: improving the clinical trial regulatory environment

• Common clinical trial preparedness and related capacity development - Many potential clinical sites and laboratories in Africa need to develop additional capacity before they can take part in SRA-quality clinical trials.

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  CTCAN will take action to strengthen clinical trial preparedness in four areas:

1. Preparedness of sites and laboratories to participate in SRA-quality clinical trials,

2. Preparedness of sites and laboratories for setting up a framework to manage site and lab clinical data,

3. Supporting strengthening regulatory authority capacity in assessing clinical trial applications,

4. Pandemic preparedness plan.

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• A business plan for the CTCAN network - The sustainability of the CTCAN network will be at the heart of this initiative

• Open science practices & data management of the CTC Platform - To maximise willingness for data sharing and ensure data interoperability, CTCAN will agree on a format for data standardisation and a harmonised data management framework that will be acceptable across African countries/regions and allow linkage to existing databases. Open science practices and adherence will be guaranteed to ensure a high impact for the intended end-users via transparency, reproducibility, and replicability of the outputs of the project. The project will also provide access to the information to be hosted on the CTC platform to all relevant stakeholders. CTCAN will make all the data from CTC platform fully accessible to all relevant end-users. All publications resulting from CTCAN will follow open publishing guidelines and will be published in open access journals. The CTCAN consortium will respect the EDCTP special condition/requirement linked to access, availability and affordability when planning the exploitation of its project outputs. However, as trial execution is not part of the project, future products or assets developed using the capacity built by CTCAN are excluded from the same availability, accessibility, and affordability principles.

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   Principles of Data Management Plan:

• Data Summary

  • Potential types of data: Various data types will be collected and generated in CTCAN, including data about clinical trials sites and laboratories and their capacities and disease expertise, regulatory and IRB processes, and clinical trial preparedness solutions such as videos, templates, guidelines, etc. 

  • Data formats: DOC, XLX, CSV, MP4, PDF, HTML, JSON 

  • Data protection: CTCAN will ensure data protection in line with requirements of pan-African, European, national, and regional data protection legislation. All data received will undergo standardisation and anonymisation where required before the integration in the CTC platform. Guidelines for accurate and transparent reporting will be adopted to define and promote best practices. A set of directives and methodologies will be developed at the start of the project to issue best practices when dealing with sensitive data and ensure data encryption and security measures based on category of sensitive data. 

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• FAIR Principles

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• FAIr

  • Findable: Use of unique and persistent identifiers.

  • Accessible: Use of open and widely accepted file and database standards. All CTC platform data will be fully visible and accessible to all previous and new users. Previous users of the CTC platform include data sharing partners who had shared data to be uploaded on the CTC platform and individual users of the platform who had uploaded their data on the platform.

  • Interoperable: Use of standards for ontologies or common data models (as specified in the FAIRplus cookbook or on fairsharing.org); data will be formatted, transformed, and documented appropriately to meet the requirements of the CTC platform and ensure interoperability.

  • Re-usable: All datasets will be accompanied by the documentation needed for the correct interpretation of the data, data pre-processing and aggregation, and to assess the quality and value of the data for potential reuse. Procedures for the long-term sustainability of the data will be set in place.

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• Data Security

  • All the data stored within the CTCAN project and CTC platform (exception will be data through partner databases where CTCAN will link to the partner platform and data) will be hosted within a cloud environment compliant with System and Organisation Controls (SOC) 3.

• Ethics

  • CTCAN will comply with the highest ethics standards, and all requirements of applicable European Union (EU) and national law (GDPR, South Africa’s Protection of Personal Information Act, or similar), free and informed consent of participants where applicable and respect for persons and human dignity.

• Roles and responsibilities in relation to data management

  • The responsibility for data management and overall coordination will be with nuvoteQ, who will safeguard open access to publications, data and metadata and the FAIR management of data. The DMP will further detail roles and responsibilities of the partners for each type of data collected and generated.