Long-term investigation following exposure to individual medicines in utero: The LIFETIME system

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47521
• EU PAS number:
  EUPAS43300
• Study ID:
  47521
• Official title and acronym:
  Long-term investigation following exposure to individual medicines in utero: The LIFETIME system
• DARWIN EU® study:
  No
• Study countries:
  Ireland

  Netherlands

  United Kingdom
• Study description:
  This project is one of design and feasibility testing. Initially this project will focus on the development of the LIFETIME System: a set of questionnaires which will be the primary source of standardised data collection and the development of infrastructure to collect the data. Following this, three observational studies will be completed which will investigate validity and feasibility of the proposed system through the collection of primary data.
• Study status:
  Ongoing

Research institution and networks

Institutions

University of Manchester

United Kingdom

Netherlands Pharmacovigilance Centre Lareb

Netherlands

University of Kwa-Zulu Natal South Africa, UK Teratology Information Service UK, UK & Ireland Epilepsy Pregnancy Register UK & Ireland, Medicines and Health Regulatory Authority UK

Networks

ConcepTION

Study timelines

Date when funding contract was signed

Planned: 01/04/2019

Actual: 01/04/2019

Study start date

Planned: 11/02/2022

Actual: 18/02/2022

Data analysis start date

Planned: 01/06/2022

Actual: 01/09/2022

Date of interim report, if expected

Planned: 30/09/2022

Date of final study report

Planned: 30/09/2023

Sources of funding

EU institutional research programme

More details on funding

Innovative Medicine Initiative (IMI)

Study protocol

Initial protocol

EUPAS43300-43376

Regulatory

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