Table 2 SPIRIT 2025 diagram of the schedule of enrollment, interventions and assessments

From: SPIRIT 2025 statement: updated guideline for protocols of randomized trials

 

Trial period

Enrollment

Post-randomization

Close-out

Timepointa

-ti to 0

0

t1

t2

t3

t4

etc.

tX

Enrolment

Eligibility screen

X

       

Informed consent

X

       

(List other procedures)

X

       

Randomization

 

X

      

Intervention or comparator

(Intervention)b

 

X

→

→

→

→

→

X

(Comparator)c

 

X

 

X

 

X

  

Assessments

(List baseline variables and tests)

X

X

      

(List outcome variables and tests)

  

X

X

X

X

Etc.

X

(List other data variables and tests)

   

X

 

X

Etc.

X

  1. Recommended content can be displayed using various schematic formats. aList target time points and acceptable time windows in this row (for example, 30 ± 3 days). bArrows indicate continuous delivery of intervention (for example, drug). cExample illustrates delivery of comparator at discrete time points (for example, psychotherapy).
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