Box 3 - Steps in a typical randomisation process

Sequence generation

  • Generate allocation sequence by some random procedure

Allocation concealment

  • Develop allocation concealment mechanism (such as numbered, identical bottles or sequentially numbered, sealed, opaque envelopes)
  • Prepare the allocation concealment mechanism using the allocation sequence from the sequence generation step

Implementation

  • Enrol participants:
  • Assess eligibility
  • Discuss the trial
  • Obtain informed consent
  • Enrol participant in trial
  • Ascertain intervention assignment (such as opening next envelope)
  • Administer intervention

Page last edited: 24 March 2010