A post-authorisation safety study (PASS) to evaluate the long-term cardiovascular and psychiatric safety profile of methylphenidate (MPH) in adult patients with attention deficit/hyperactivity disorder (ADHD) in European Countries (PASS on methylphenidate in adults)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Danish registries (access/analysis)

  Sweden National Prescribed Drugs Register / Läkemedelsregistret

  Norwegian Health Registers
• Data source(s), other:
  Norwegian Prescription Database (NorPD)
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Disease registry

  Electronic healthcare records (EHR)

  Other
• Data sources (types), other:
  Exposure registry

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation moment:
  after data extraction
• Data characterisation details:
  Routine procedures included checking electronic files, maintaining security and data confidentiality, following analysis plans, and performing quality control checks of all programes. Each data source custodian maintained any patient-identifying information securely on site according to internal standard operating procedures. The study is sub-contracted by IQVIA to a third party in Norway, and the datasets and analytic programes were stored according to the vendor’s procedures.; Security processes were in place to ensure the safety of all systems and data. Every effort was made to ensure that data are kept secure so that they cannot be accessed by anyone except selected study staff.; Appropriate data storage and archiving procedures were followed. Standard procedures to restore files in the event of a hardware or software failure were in place at each data source.; The study sponsor did not have access to health records at the level of the individual patient but only to tables with aggreg