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ASH Clinical Trial Map
Design and Planning
Conduct and Operations
Analysis and Dissemination
ASH® TOOLKIT
Useful Resources
Abbreviations
Conceptual Planning
Design and Planning
Review cycles
Systems setup
Site setup and
implementation
Protocol and trial
documentation development
E
s
t
a
b
l
i
s
h
f
o
u
n
d
a
t
i
o
n
a
l
k
n
o
w
l
e
d
g
e
P
r
e
p
a
r
e
e
s
s
e
n
t
i
a
l
t
r
i
a
l
d
o
c
u
m
e
n
t
s
Conduct
feasibility
assessment
Start drafting
the CSR
Internal
assessment
Set up data
capture system
Build
randomization
system
Set up
adjudication
system
Site
qualification –
surveys and
pre-study visits
Site-specific
budget
development
Set up
site-specific
infrastructure
Site
initiation
visit
Sample size
Site selection
Endpoints
Participant
population
Central study
team
Funders
Conduct
consultations
with key
stakeholders
Research
requirements,
guidelines,
and principles
ACT
definition
and scope
Familiarization
with SPIRIT
Trial design
options
IND/IDE
definition
and scope
Randomization
and blinding
procedure
Participant
recruitment
strategy
Statistical
analysis
approach
Risk
assessment and
management
plan
Monitoring
plan
Data
management
and sharing
plan
Data
monitoring and
safety plan
SAP
Participant
information
sheet
CRFs
Informed
consent
forms
SOPs
IND / IDE
submission and
review
Obtain site
approval and
sign contracts
Ethics board
Contracts
Conduct and operations
Site activation and
participant recruitment
Ongoing study conduct
and monitoring
Study completion
Data management
Safety evaluation
Protocol compliance and deviations
Regulatory reporting and communications
Internal study activities
Participant management
Implement
participant
recruitment
strategy
Follow study
entry and
allocation
procedures
Ongoing study
conduct and
monitoring
Interim analysis
Database
lock
Site close-out
activities
Result
dissemination
Analysis and dissemination
T
r
i
a
l
c
o
m
p
l
e
t
e
Develop and
publish the
manuscript
Disseminate
results to
participants
Complete any
secondary
dissemination
activities
Conduct the
prespecified
analysis