Recruitment and allocation
Track enrollment assignment and treatment
Random sequence generation, allocation concealment and blinding are separate protections. Concealment prevents knowledge of upcoming assignments; blinding concerns information after assignment. Track treatment receipt without replacing randomized assignment.
Flow diagram
Steps
Screen potential participants
Specify recruitment sources, screening permissions and eligibility.
Obtain consent and enroll
Follow approved consent procedures before required study interventions.
Randomize with concealed allocation
Specify sequence generation, ratio, strata and independent implementation.
Maintain and assess blinding
Specify who is blinded, unblinding conditions and emergency procedures.
Assigned to study arm A
Define the first intervention group without assuming an allocation ratio.
Assigned to study arm B
Define the comparator or second intervention. Add further arm branches if required.
Treatment received in arm A
Track nonreceipt, adherence and deviations separately from assignment.
Treatment received in arm B
Track nonreceipt, adherence and deviations separately from assignment.
Recruitment and allocation
End flow
Tables and supporting information
Allocation specification
Enter chosen ratio and procedures; no allocation counts are supplied.
Receipt and deviations
Preserve assignment and treatment-received distinctions.