Table 3

Roles and responsibilities

Coordinating centre-principal investigator and study teamData management team
Study preparation
 Study grantX
 Study protocol and revisionsX
 Ethics approval and amendmentsX
 Case report form (CRF)XX
 Study manualX
 Training and supervisionXX
Study conduct
 Informed consentX
 Accessing participant medical recordsX
 Collecting biospecimensX
 Packaging and shipping biospecimensX
 Analysing biospecimens*X
 Study documentationX
Data management
 Database development (eCRF†)X
 Data entryX
 Data verificationXX
 Data archivingX
 Data queriesXX
Quality control
 Trial oversightX
 Assessment and reporting of SAEs‡X
Data analysis and reporting
 Data analysis planX
 Data analysis§X
  • *Blinded trained laboratory staff (CDL Laboratories).

  • †eCRF: electronic Case Report Form.

  • ‡SAE: Serious Adverse Event.

  • §Blinded data analyst (StatSciences Inc).