Demonstration study 2.5.5 of the ConcePTION project; Validation of primary source pregnancy exposure and outcomes (pharmacovigilance data)

Study identification

• EU PAS number:
  EUPAS44505
• Study ID:
  44506
• Official title and acronym:
  Demonstration study 2.5.5 of the ConcePTION project; Validation of primary source pregnancy exposure and outcomes (pharmacovigilance data)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands

  United Kingdom
• Study description:
  The overarching aim of this demonstration project is to ascertain whether self-reporting methods of data collection in pregnancy exposure and outcomes can be considered reliable for pharmacovigilance purposes. The main objective of demonstration study 2.5.5 is to compare the completeness and accuracy of self-reported pregnancy pharmacovigilance data with corresponding data supplied by healthcare professionals (HCPs) in a variety of different contexts. The validation exercises undertaken in this demonstration project will be split into two main sub-studies.
• Study status:
  Planned

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Netherlands Pharmacovigilance Centre Lareb

Netherlands

University of Manchester

United Kingdom

Novartis Pharmaceuticals

University of Manchester Manchester, United Kingdom, Novartis Pharma AG Basel, Switzerland, UK Teratology Information Serrvice Newcastle upon Tyne, United Kingdom, University of KwaZulu-Natal Durban, South Africa

Study timelines

Date when funding contract was signed

Planned: 01/04/2019

Actual: 01/04/2019

Study start date

Planned: 01/03/2022

Data analysis start date

Planned: 01/06/2022

Date of final study report

Planned: 30/09/2023

Sources of funding

Pharmaceutical company and other private sector 

EU institutional research programme

More details on funding

EFPIA, IMI

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable