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- Routemap
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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
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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.
- Recent changes
- Recent changes that have been made to the CT-Toolkit
- News
- Latest news from CT-Toolkit
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- FAQs
- What are the UK regulations? The Medicines and Healthcare ...
- Glossary
- Contact us
- If you have any queries or feedback relating the ...
- Accessibility
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- Complaints
- Introduction We always want to ensure that you have ...
- Freedom of Information
- The NIHR, Evaluation, Trials and Studies (NETS) programmes, fund ...
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- Disclaimer
- Unless otherwise indicated, the advice in the Clinical Trials ...