Clinical Research

Procedures for conducting clinical studies, ensuring compliance with ethical, regulatory, and scientific standards.

CR001 Establishing and Maintaining Investigator Site Files, Trial Master Files and Sponsor Files

CR003 Suspected Serious Breaches

CR004 Recording and Reporting Study Data

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SOP v6.0 (242.45 KB / PDF)
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CR004-T01 Source Data Plan v2.0 (244.63 KB / DOCX)

CR005 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for CTIMPs

CR006 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for Non-CTIMPs

CR008 Preparing and Submitting Progress and Safety Reports

CR009 Study Closure and Archiving

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CR010 Management of Protocol and GCP Deviations and Violations

CR011 Research Study Reports and Publication of Results

CR012 Identifying, Recording and Reporting Adverse Events and Device Deficiencies

CR013 CRF Design and Implementation

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CR013-T01 CRF Review v6.0 (86.83 KB / DOCX)
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CR014 Suspected Research Misconduct

CR015 Data Monitoring Committee and Trial Steering Committee Charters

CR016 Dose Progression and Stopping Rules

CR017 Organisational Information Document Completion

CR018 Management of Complaints