Global Research in Paediatrics

Home > Objectives and results > Results summary - what GRiP has achieved

What GRiP has achieved so far

Last updated: 28/06/2017

 

This page contains an up-to-date list of all the approved GRiP deliverables. Check this page for new GRiP deliverables in each Work Package. Click on each WP page to get details on each deliverable.

 

WP1 – Joint Paediatric Clinical Pharmacology International Training Program

 

Final Report on a Virtual Learning Environment (VLE)

 

Report about Fellowships in Paediatric Clinical Pharmacology

 

Inventory of exchange programs in paediatric clinical pharmacology

 

Detailed core curriculum of specialisation in paediatric clinical pharmacology: GRiP Paediatric Clinical Pharmacology Fellowship curriculum

 

Inventory of existing training programs an courses for inclusion in Training Program Palette

 

First Report on a Virtual Learning Environment (VLE)

 

Specialisation program in paediatric clinical pharmacology

 

Master program in paediatric clinical pharmacology: Scope, Organization, Training

 

Report on the scope, qualifications and training for other qualifications in Paediatric Clinical Pharmacology

 

Detailed plan describing the critical path to pan-European standardization of qualifications and credentialing in paediatric clinical pharmacology

 

Introductory Training Program in Peadiatric Clinical Pharmacology (GRiP Roadshow): Scope, Organization, Training

 

First Report on a Masters program in paediatric clinical pharmacology

 

Prospectus for a training program for investigators in paediatric clinical trials


Report on the needs assessment of training in Paediatric Clinical Pharmacology

 

 

WP2 – Integrated Infrastructure For Paediatric Epidemiological And Post Marketing Drug Studies 

 

Report on methods of retrospective safety signal generation in paediatrics from longitudinal Healthcare DBs

 

Comparison of methods for safety signal generation from pharmacovigilance databases and longitudinal healthcare DBs

 

Proof of concept studies: comparative effectiveness (drug/vaccine utilization)

 

Integrated online research infrastructure

 

Description of Data Sources

 

Report on international adverse drug events (ADE) databases

 

Report on terminology mapping and AEFI/ADE definitions

 

Report and demonstrator for safety evaluation designs

 

Report on methods of safety signal generation in paediatrics from pharmacovigilance databases

 

Report on ethical and governance issues related to processing of healthcare data

 

Developing training material on pharmacoe-epidemiology and pharmacovigilance

 

Report and Jerboa demonstrator for incidence and prevalence calculations

 

Report on confounding adjust. for compare. effectiveness res. in elect. med. records and claims DBs

 

 

WP3 – Research Tools To Facilitate Interoperability In Paediatric Research

 

Models for information sharing for Human Research Subject Protection among Ethics Committees and Institutional Review Boards (update)

 

Evidence- and consensus-based guidance for the design, conduct and reporting of paediatric CTs (4) - final report


Evidence- and consensus-based guidance for the design, conduct and reporting of paediatric CTs (3)


Reports on harmonised terminology (1-2)


Models for info. sharing for Human Res. subject protect. among ECs and Institut. Review Boards (1)


Evidence- and consensus-based guidance for the design, conduct and reporting of paediatric CTs (2)


Report on harmonised terminology (3)


Report on harmonised outcome assessments, endpoints and biomarkers to evaluate paed. drug response (1)


Evidence- and consensus-based guidance for the design, conduct and reporting of paediatric CTs (4)


Report on harmonised terminology (4)


Report on harmonised terminology (5)


Report on harmonised outcome assessments, endpoints and biomarkers to evaluate paed. drug response (2)


Models for info. sharing for Human Res. subject protect. among ECs and Institut. Review Boards (2)


Report on harmonised terminology (6)


Report on harmonised terminology (7)


Report on harmonised outcome assess, endpoints and biomarkers to evaluate paed. drug response (1)


Report on harmonised terminology (8)


An evidence- and consensus-based tool for harmonization of information given to parents and patients in the recruitment process


An evidence- and consensus-based tool related to the roles and responsibilities od Data safety and Monitoring Committees in paediatric CTs (2)


Models for info sharing for Human Res. subject protect. among ECs and Institut. Review Boards (3)

 

Report on harmonised outcome assess, endpoints and biomarkers to evaluate paediatric drug response (3)

 

Reports on harmonised terminology (9)

 

Report on harmonised outcome assess, endpoints and biomarkers to evaluate paediatric drug response (4)

 

Report on harmonised technical acquisition of clinical data in paediatric research

 

 

WP4 – New Methods For Clinical Studies In Paediatrics

 

First Report on the activities of the Expert Groups

 

Second report on the activities of the Expert Groups

 

Recommendations for an adequate sample size definition

 

Recommendations for modeling and simulation

 

Recommendations for an appropriate comparator definition

 

List of principles to be considered when evaluating extrapolation approach from adults data

 

Recommendations fro innovative design to be adopted in an agreed PIP

 

Development of training modules to be included in the GRiP training programme palette

 

GRiP Position paper on CTs

 

 

WP5 – Paediatric Formulations

 

Launch of paediatric formulation webpage on the GRiP website

 

Accreditation of on-line training webinar programme on paediatric formulation

 

Inventory of experts on paediatric formulations

 

User guide to e-mail group of experts and web forum

 

Report on European Paediatric Formulation Initiative (EuPFI) database (1)

 

Reports describing the online services (1)

 

Reports describing the online services (2)

 

Report on the EuPFI database (2) 

 

Proof of concept paper on innovative drug delivery technologies for children

 

Report on the EuPFI database (3)

 

Report describing the online services (3)

 

Recommendations on optimal designs

 

 

WP6 – Drug development in neonates

 

Report on existing neonatal networks outside EU

 

First Report on standardised and validated definitions

 

Reports on preclinical and clinical studies

 

Final Report on standardised and validated definitions

 

 

WP7 – Dissemination And Networking

 

Communication Plan

 

Project Web Site

 

Report on Networking Activities (1)

 

Report on Networking Activities (2)

 

First report on KTEM strategies 

 

Report on Networking Activities (3)

 

 

WP8 – Scientific Coordination

 

Quality Assurance Guidelines and Procedures

 

Interim assessment of the project (1)

 

Interim assessment of the project (2)

 

 

WP9 – Project Management

 

Management Plans

 

Technical and Financial Periodic Report (1)

 

Technical and Financial Periodic Report (1)

 

Report on network function, value for money and sustainability

 

Technical and Financial Periodic Report (3)