Protocol for the Effectiveness Check of the Awareness and Knowledge of Educational Materials for the Eligard Risk Minimization Program

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20725
• EU PAS number:
  EUPAS9553
• Study ID:
  20725
• Official title and acronym:
  Protocol for the Effectiveness Check of the Awareness and Knowledge of Educational Materials for the Eligard Risk Minimization Program
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Hungary

  Italy

  Poland

  Spain
• Study description:
  Periodic multi-country surveys of targeted HCPs will be conducted to measure awareness of the Dear Healthcare Provider Communication (DHPC) and other educational materials as well as knowledge of lack of efficacy that may occur with improper reconstitution of Eligard®/Depo-Eligard®. The surveys will be sent to a random sample of individuals receiving the DHPC, stratified by target group. To be included in the analysis of survey responses, respondents must perform one of the following activities as indicated by their survey responses: reconstitute Eligard®/Depo-Eligard® for use in patients, administer Eligard®/Depo-Eligard® to patients, or dispense the medication to patients or healthcare professionals. The survey instrument will be a structured, closed-answer questionnaire of pertinent provider information and key elements relating to the reconstitution of Eligard®/Depo-Eligard®.
• Study status:
  Finalised

Research institutions and networks

Institutions

GfK Health

Study timelines

Date when funding contract was signed

Planned: 01/05/2015

Actual: 19/06/2015

Study start date

Planned: 01/06/2015

Actual: 14/10/2015

Date of final study report

Planned: 30/09/2015

Actual: 30/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma

Study protocol

Initial protocol

ELIGARD_PASS_FINALDRAFT_20141216_V1

Updated protocol

ELIGARD_7015-MA-3019_v1_1

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)