Time intervals between key milestones of studies evaluating the effectiveness of Risk Minimisation Measures assessed by PRAC

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107467
• EU PAS number:
  EUPAS107458
• Study ID:
  107467
• Official title and acronym:
  Time intervals between key milestones of studies evaluating the effectiveness of Risk Minimisation Measures assessed by PRAC
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This is a retrospective cohort study including completed PASS that evaluated RMM effectiveness. ; This study involves a quantitative analysis of time intervals between key milestones of PRAC regulatory procedures for requesting and assessing protocols and study reports of RMM effectiveness PASS. ; We will use a dataset of PASS evaluating RMM effectiveness assessed by PRAC between 2016 and 2022.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Study timelines

Date when funding contract was signed

Planned: 01/06/2023

Actual: 01/06/2023

Study start date

Planned: 01/08/2023

Actual: 01/08/2023

Data analysis start date

Planned: 01/11/2023

Date of final study report

Planned: 01/03/2024

Sources of funding

Other

More details on funding

Medicines Evaluation Board

Study protocol

Initial protocol

protocol 20240130.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable