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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)
Trial Registration: Good practice (relevant to all trials)
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)
Ongoing Management & Monitoring: Legal requirement (relevant to all trials)
GCP & Serious Breach Reporting: Legal requirement (relevant to all trials)
Safety Reporting: Legal requirement (relevant to all trials)
Progress Reporting: Good practice (relevant to all trials)
MHRA Inspection: Legal Requirement (Specific for trials within the CT Regulations scope)
Audit: Good practice (relevant to all trials)
Substantial Amendments: Legal requirement (relevant to all trials)
Addition of New Sites & Investigators: 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)

The Clinical Trials Toolkit was initially developed to help clinical trialists and R&D managers understand the regulations and requirements for conducting trials.

Recent changes: Recent changes that have been made to the CT-Toolkit

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