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The Clinical Trials Toolkit is an interactive colour-coded routemap* ...
Trial Planning & Design
Good practice
Within the scope of the Clinical Trial Regulations?
Question
Risk Assessment
Good practice
Sponsorship
Legal requirement
Protocol Development
Legal requirement
GCP & Serious Breach Reporting
Legal requirement
Trial Management & Monitoring
Legal requirement
Trial Documentation
Legal requirement
Trial Supplies
Legal specific
Pharmacovigilance
Legal specific
R&D Consultation
Good practice
Funding Proposal
Standard
Peer Review
Good practice
Funding Secured
Standard
Trial Master File
Legal requirement
Unique Trial Number
Good practice
EudraCT Number
Legal specific
Confirm Sponsor
Legal requirement
Feasibility and Investigator Selection
Good practice
Contracts & Agreements
Good practice
Final Protocol
Legal requirement
CI Checklist Before Seeking Approval
Checklist
IRAS
Good practice
CTA Submission
Legal specific
Ethics Submission
Legal requirement
R&D Submission
Legal requirement
Permissions & Approvals Obtained
Legal requirement
Final Trial Management Documentation
Legal requirement
Trial is Abandoned
Good practice
Trial Begins
Standard
Informed Consent
Legal requirement
Safety Reporting
Legal requirement
Progress Reporting
Good practice
Ongoing Management & Monitoring
Legal requirement
MHRA Inspection
Legal specific
Audit
Good practice
Addition of New Sites & Investigators
Legal requirement
Substantial Amendments
Legal requirement
Urgent Safety Measures
Legal requirement
Temporary Halt or Early Termination
Legal requirement
Trial does not Recommence
Legal requirement
End of Trial Declaration
Legal requirement
Statistical Data Analysis
Good practice
Clinical Trial Summary Report
Good practice
Dissemination of Results
Good practice
Archiving
Legal requirement
About this site
The Clinical Trials Toolkit was initially developed to help clinical trialists and R&D managers understand the regulations and requirements for conducting trials.
CT-Toolkit Feedback
The value of the Clinical Trials Toolkit lies in its ability to provide up to date information we therefore welcome your feedback and comments.
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Recent changes that have been made to the CT-Toolkit
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Unless otherwise indicated, the advice in the Clinical Trials ...