Review of studies evaluating the effectiveness of risk minimisation measures evaluated by PRAC (EffectiveRMM)

ENCePP Code of conduct

No

Data sources

• Data source(s), other:
  EMA’s Document Records Electronic Archive Management (DREAM) system, European Review System for eCTDs (EURS)
• Data sources (types):
  Other
• Data sources (types), other:
  Documents related to the assessment of industry-sponsored PASS evaluating the effectiveness of RMM stored both in DREAM and EURS

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No