Deliverables
The ConcePTION project is publishing results in scientific journals, and in reports to the European Commission. All public deliverable reports are published Open Access. You can explore them in the list below, or have a look at all that is available in the IMI ConcePTION Zenodo community.
- D1.1 Spreadsheet containing all additional data sources for the ConcePTION Data Source Catalogue
- D1.2 Core evidence elements for generating medication safety evidence for pregnancy using population-based data
- D1.3 Final study protocols for demonstration projects submitted to EU PAS register
- D1.4 Report on algorithms to define pregnancy, maternal morbidity and maternal, perinatal and childhood outcomes
- D1.5 Submitted manuscript of a guidance document outlining standards for conducting medication utilisation studies in pregnant women data collection and analytic standards for established and newly marketed products
- D1.6 Overview of submitted manuscripts/abstracts of all five demonstration projects
- D1.7 Submitted manuscript of a guidance document outlining lessons learned for conducting drug utilization and medication safety studies based on secondary data sources in pregnancy using the ConcePTION pipeline
- D2.1 Report on stakeholder meeting describing the model for a 21st century pregnancy data collection and signal detection system which should be able to replace traditional pregnancy registries
- D2.2 Report describing the metadata model (variables) for data collection on pregnancy data sources
- D2.3 Report describing existing coding systems, schemes and regulatory guidelines of reported medication exposed pregnancies
- D2.5 Protocols of selected demonstration projects 1-5 uploaded on HMA-EMA Catalogues
- D2.6 Report on data sources for reported pregnancies and handling processes
- D2.7 Report describing core data elements for the collection of pregnancy, immediate child outcomes and longer-term child outcomes in medication exposed pregnancies
- D2.8 Common data model and data elements required for retrospective case reports and primary prospective data collection on exposure to medicinal products and outcomes of pregnancy
- D2.9 Report with publications of demonstration projects
- D2.10 Best practice guidance for evaluation of case reports on pregnancy and signal detection
- D3.4 In vitro transport data for at least 10 model drugs in both in vitro models (including validated bioanalytical methods and drug-specific properties determining blood to milk transfer rates)
- D3.5 In vivo data on lactation transfer in one or more animal species
- D3.6 Generic PBPK template for predicting drug concentration time profiles in human breast milk
- D3.7 Validation of an animal model for lactation transfer (including translation from animal to human using available human data)
- D3.8 Individual PBPK model for predicting exposure of infants to selected drug
- D3.9 Integrated mother-infant PBPK model verified against human lactation data
- D3.10 Optimized protocol for non-clinical data generation regarding drug milk excretion and breastfed infant drug exposure
- D3.11 EMA Qualification Advice: Making the best use of the new nonclinical and in silico predictive tools generated in this WP3 to inform risk assessment on medication use during lactation
- D4.2 List with names and expertise of expert delegates group for BBMRI Technical committee
- D4.3 Sampling, storage and handling standards, consent procedures and templates
- D4.4 Description of basic quality management structure for biobanking and pre-analytical handling of human breast milk specimens
- D4.5 Protocols for 5 approved demonstration studies uploaded on EU-PAS register
- D4.6 Report with methods and analytical results of demonstration projects
- D4.7 Report with standardized procedures for biobank sample analysis
- D4.8 Standard documents for preexamination processes for breast milk handling and Guideline for Biobanking
- D4.9 Report with publications on the results of the demonstration studies & cross validation with WP3 plus recommendation
- D4.10 Way of working of Scientific Governance Board and members
- D5.1 Report with description of the functionality of the knowledge database
- D5.2 Report describing communication plan and governance
- D5.3 Report with procedures for evidence retrieval and synthesis for the knowledge bank
- D5.4 Report with landscape analysis
- D5.5 Report with planned training programmes, learning goals, target audienceReport with planned training programmes, learning goals, target audience
- D5.6 Report on the methods and results of the communication campaign to stimulate reporting and participation in studies/registries and publication of analysis of communication methods
- D5.7 Report on E-learning training programme and accreditation plus sustainability
- D5.8 Report describing synthesis of evidence and testing the knowledge databank and recommendations for sustainability
- D5.9 Interoperability and knowledge bank access description system which allows content from the knowledge databank to be adapted in national settings
- D5.10 Annual report on external communications for impact assessment April 2019- March 2020
- D5.11 Annual report on external communications for impact assessment – 2
- D5.12 Annual reports on external communication results for impact assessment
- D5.13 Annual report on external communications for impact assessment January – December 2022
- D5.14 Annual report on external communications for impact assessment January 2023 – December 2023
- D5.15 Annual report on external communications for impact assessment January 2024- December 2024
- D6.1 Roadmap of planned project outputs, including qualification advice submissions, mapped to stakeholder needs and planned stakeholder interactions
- D6.2 Report explaining the regulatory procedures, their scientific requirements, priorities and decision-making pathways regarding the use of medicines in pregnancy and lactation
- D6.3 Report describing toolbox of methodologies and approaches for WPs to engage stakeholders regarding new evidence on the use of medicines in pregnancy and lactation
- D6.4 Engaging with regulators on the use of new evidence in decision making
- D6.5 Recommendations for a sustainable information production, dissemination and engagement ecosystem
- D7.1 User requirements and metadata model for the FAIR data catalogue from WP1, 2 &7 – task 7.4
- D7.2 Description of the operational platform for data sharing and task management system
- D7.3 Report on data access models and rules
- D7.4 Report on initial information and research governance for WP1-5
- D7.5 Report on existing common data models and proposals for ConcePTION
- D7.6 Prototype of FAIR data catalogue-1st
- D7.7 Prototype of FAIR data catalogue – 2nd
- D7.9 Test report for FAIR data catalogue
- D7.8 Database with reprotox data on platform
- D7.10 Test report for FAIR data catalogue 2nd
- D7.11 Wiki page with description of tools and GITHUB repository
- D7.12 Wiki page with description of tools and GITHUB repository
- D7.13 Interim Report on Ethical Issues – task 7.3
- D7.14 Report on data characterisation
- D7.15 Final FAIR data catalogue
- D7.17 Report and machine learning tools to integrate reprotox data with clinical data
- D7.18 Report confirming all relevant documents for using, producing or collecting human cells or tissues
- D7.19 Report providing the details on the informed consent procedures, informed consent sheets and information sheets for demonstration studies in WP2 & 5. IRB approval procedures and confirmation for WP2 demonstration studies and WP5 outreach
- D7.20 Templates and guidance for local and central Data Privacy Impact Assessments for datasources and repository for continuous collection of completed forms and approvals
- D7.22 Report confirming that all the relevant documents for using animal experiments prior to the start of the research activity raising ethics issue and that they are kept on file
- D7.23 Final Report on ethical issues
- D8.1 Project management plans
- D8.2 Collaborative Website (intranet)
- D8.3 Contact database
- D8.4 Detailed project plan, plus tracking tools, to be maintained throughout the life of the project
- D8.5 Data Management Plan
- D8.6 Public website and social media plan
- D8.7 Additional third party selection procedure description
- D8.8 Reports from Advisory Board and Ethic Report 1
- D8.9 Reports from Advisory Board and Ethics Report year 2
- D8.10 Reports from Advisory Board and Ethics Report year 3
- D8.11 Reports from Advisory Board and Ethics Report year 4
- D8.12 Reports from Advisory Board and Ethics Report Year 5
- D8.13 Landscape analysis and cost analysis
- D8.14 Minutes of annual general assembly meetings 1Minutes of annual general assembly meetings 1
- D8.15 Minutes of annual general assembly meetings 2
- D8.16 Minutes of annual general assembly meeting 3
- D8.17 Minutes of annual general assembly meeting 4
- D8.18 Sustainability Plan
- D8.19 Updated Data Management Plan
- D8.20 Report on lessons learned from the conduct of the PoC feasibility assessments and implications for the sustainability plan
- D8.21 Final Data Management Plan