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

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SOP v6.0 (526.73 KB / PDF)
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CR003 Suspected Serious Breaches

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SOP v6.0 (1.09 MB / 0)

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

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SOP v8.0 (948.67 KB / 0)
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CR006 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for Non-CTIMPs

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SOP v9.0 (597.68 KB / 0)
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CR008 Preparing and Submitting Progress and Safety Reports

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SOP v9.0 (872.72 KB / PDF)
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CR008-T01 DSUR Template v2.0 (100.44 KB / DOCX)

CR009 Study Closure and Archiving

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SOP v6.0 (424.36 KB / PDF)
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CR010 Management of Protocol and GCP Deviations and Violations

SOP CR010 v8.0 Training

CR011 Research Study Reports & Publication of Results

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SOP v5.0 (904.26 KB / 0)

CR012 Identifying, Recording And Reporting Adverse Events And Device Deficiencies

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SOP v5.0 (924.28 KB / 0)
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CR013 CRF Design and Implementation

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SOP v5.0 (475.75 KB / PDF)
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CR013-T01 CRF Review v6.0 (86.83 KB / DOCX)
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CR014 Suspected Research Misconduct

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SOP v5.0 (889.18 KB / PDF)

CR015 Data Monitoring Committee and Trial Steering Committee Charters

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SOP v4.0 (875.91 KB / 0)

CR016 Dose Progression and Stopping Rules

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SOP v1.0 (457.52 KB / PDF)

CR017 Organisational Information Document Completion

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SOP v4.0 (692.36 KB / 0)

CR018 Management of Complaints

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SOP v2.0 (565.94 KB / 0)