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The Clinical Trials Toolkit is an interactive colour-coded routemap* ...
Trial Planning & Design
Good practice (relevant to all trials)
Within the scope of the Clinical Trial Regulations?
Question
Risk Assessment
Good practice (relevant to all trials)
Sponsorship
Legal requirement (relevant to all trials)
Protocol Development
Legal requirement (relevant to all trials)
Trial Management & Monitoring
Legal requirement (relevant to all trials)
Trial Documentation
Legal requirement (relevant to all trials)
Trial Supplies
Legal Requirement (Specific for trials within the CT Regulations scope)
Pharmacovigilance
Legal Requirement (Specific for trials within the CT Regulations scope)
R&D Consultation
Good practice (relevant to all trials)
Funding Proposal
Standard process (relevant to all trials)
Peer Review
Good practice (relevant to all trials)
Funding Secured
Standard process (relevant to all trials)
Trial Master File
Legal requirement (relevant to all trials)
Unique Trial Number
Good practice (relevant to all trials)
EudraCT Number
Legal Requirement (Specific for trials within the CT Regulations scope)
Confirm Sponsor
Legal requirement (relevant to all trials)
Feasibility and Investigator Selection
Good practice (relevant to all trials)
Contracts & Agreements
Good practice (relevant to all trials)
Final Protocol
Legal requirement (relevant to all trials)
CI Checklist Before Seeking Approval
Checklist
IRAS
Good practice (relevant to all trials)
CTA Submission
Legal Requirement (Specific for trials within the CT Regulations scope)
Ethics Submission
Legal requirement (relevant to all trials)
R&D Submission
Legal requirement (relevant to all trials)
Permissions & Approvals Obtained
Legal requirement (relevant to all trials)
Final Trial Management Documentation
Legal requirement (relevant to all trials)
Trial is Abandoned
Good practice (relevant to all trials)
Trial Begins
Standard process (relevant to all trials)
Informed Consent
Legal requirement (relevant to all trials)
Safety Reporting
Legal requirement (relevant to all trials)
Progress Reporting
Good practice (relevant to all trials)
Ongoing Management & Monitoring
Legal requirement (relevant to all trials)
GCP & Serious Breach Reporting
Legal requirement (relevant to all trials)
MHRA Inspection
Legal Requirement (Specific for trials within the CT Regulations scope)
Audit
Good practice (relevant to all trials)
Addition of New Sites & Investigators
Legal requirement (relevant to all trials)
Substantial Amendments
Legal requirement (relevant to all trials)
Urgent Safety Measures
Legal requirement (relevant to all trials)
Temporary Halt
Legal requirement (relevant to all trials)
Early Termination
Legal requirement (relevant to all trials)
End of Trial Declaration
Legal requirement (relevant to all trials)
Statistical Data Analysis
Good practice (relevant to all trials)
Clinical Trial Summary Report
Good practice (relevant to all trials)
Dissemination of Results
Good practice (relevant to all trials)
Archiving
Legal requirement (relevant to all trials)
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.
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Recent changes that have been made to the CT-Toolkit
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