Randomised
Controlled
Trials
Qualitative and mixed
methods studies
Technology
Assessment
Reports
Pilot and
Feasibility Studies
Economic
Evaluations
References
Reporting
guidelines
PGfAR
Dual publication
Forms
Permissions
Copyright
Abstract
Scientific
summary
Plain English
summary
Report
submission
Evidence Synthesis/
Systematic Reviews
Editorial
review
process
Step by step
guide to
obtaining
permissions
Editorial policies
Editorial review
timescales
Production
process
Dissemination
Open access
Production
timescale
Publication
ethics
End of Trial
Declaration
Safety
Reporting
MHRA
Inspection
Substantial
Amendments
Final Trial
Management
Documentation
Archiving
Ongoing Management
& Monitoring
Urgent Safety
Measures
Temporary Halt
Early Termination
CTA Submission
Ethics
Submission
Informed
Consent
Permissions
& Approvals
Obtained
R&D
Submission
Trial
Master File
EudraCT
Number
Confirm
Sponsor
Sponsorship
Protocol
Development
Trial
Management &
Monitoring
Trial
Supplies
Pharmacovigilance
Trial Documentation
Final
Protocol
Addition of
New Sites &
Investigators
Risk
Assessment
Peer
Review
Audit
Trial is
abandoned
Dissemination
of Results
Clinical Trial
Summary
Report
Progress
Reporting
IRAS
Contracts &
Agreements
Feasibility &
Investigator
Selection
Statistical
Data Analysis
R&D
Consultation
Trial
Planning
& Design
Unique
Trial
Number
Trial
Begins
CI Checklist
Before Seeking
Approval
Funding
Secured
Funding
Proposal
Within the
scope of the
CT Regulations ?
Key to symbols
Demonstrates processes that
can be done in parallel
Demonstrates that not all
processes will apply to all trials
GCP & Serious
Breach
Reporting