1. S A Overarching SOPs Funding Secured Training Records
Managament of External Staff
File Notes
GCP Training
Conduct of Research Studies and trials
Study related s
Expedited trust approval
Safety Reporting
SOP062
Trial Master File
Funding Proposal
SOP023
SOP009
SOP024
Progress Reporting
R&D Consultation
EudraCT No.
CTA Submission
Peer Review
Unique Trial No.
SOP014
Ongoing management & monitoring
Within scope of CT regulations?
Final Protocol
SOP016
Trial Abandoned S
Sponsorship
Confirm Sponsor
SOP048
Trial Planning & Design
Risk Assessment
Permissions & Approvals Obtained
SOP065
Trial Begins
End of Trial Declaration
MHRA Inspection
Dissemination of Results
IRAS
SOP031
SOP021 A
Feasibility & Investigator Selectiiu8o9on
Ethics Submission
Final Trial management documentation
Informed Consent
Audit
Statistical Data Analysis
CI Checklist before seeking approval
Archiving
SOP063
Clinical Trial Summary
SOP011
SOP005
SOP003
SOP015
SOP013
SOP060
SOP041
SOP030
SOP017
Substantial amendments
Protocol Development
Contracts & Agreements
SOP018
SOP019
SOP037
Addition of new sites & investigators
R&D Submission
SOP066
SOP024
SOP034
SOP025
SOP038
GCP & Serious breach reporting
Urgent safety measures
Trial Documentation
SOP050
SOP051
SOP052
SOP020
SOP060
Trial management & monitoring
SOP071
SOP009
Trial Supplies
Pharmacovigilence
SOP072
SOP073
SOP074
SOP075
SOP076
SOP081 SO
Key to Symbols
Demonstrates processes that can be done in parallel
Demonstrates that not all processes will apply to all trials
Relevant to all trials
Specific for trials within Directive’s scope
Standard Process
Legal Requirement
Good Practice
SOP012
SOP069
SOP079
Temp halt or early termination
Trial does not recommence
SOP077
SOP078
SOP080
Data Managment