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.
- 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
- D2.7 Report with core data elements to collect long term outcomes
- D3.1 Report on scope and limitations of in vivo and in vitro non-clinical and computational models for drug milk excretion and breastfed infant exposure; Selection of a panel of at least 10 model compounds for initial evaluation of non-clinical models
- D3.2 Report on lactation characteristics of animal species; Selection of the animal species to be used in in vivo studies
- D3.3 Report on characterization in vitro human/animal mammary epithelial cell cultures models, including comparison between in vitro models
- 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
- D4.1 Summary and review of collected SOPs from project partner and literature
- 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
- 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 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
- D5.10 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
- 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
- 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 (1st)
- D7.10 Test report of FAIR data catalogue (2nd)
- D7.11 Wiki page with description of tools and GITHUB repository
- D7.13 Interim Report on Ethical Issues – task 7.3
- D7.16 Report with publications on results of component algorithms
- 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 Ethics 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
- D8.13 Landscape analysis and cost analysis
- D8.14 Minutes 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