Standard Operating Procedures (SOPs)
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Study set up
- Obtaining sponsorship for research studies (PDF - 0.29 Mb)
- Research applications (PDF - 0.37 Mb)
- Research staff training (PDF - 0.27 Mb)
- Risk assessment and risk rating (PDF - 0.27 Mb)
- Study initiation (PDF - 0.25 Mb)
- Vendor assessment (PDF - 0.24 Mb)
- Writing research protocols (PDF - 0.26 Mb)
- Site selection (PDF - 0.15 Mb)
- Contracts and agreements (PDF - 0.38 Mb)
- Data sharing in research (PDF - 0.32 Mb)
- Data protection and confidentiality
(PDF - 0.21 Mb) - Risk assessment process
(PDF - 0.25 Mb)
- Trial documentation
- Trial conduct
- Pharmacovigilance and regulatory
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Data management and statistics
- Completing a case report form (Sponsored / Co-sponsored) (PDF - 0.16 Mb)
- Data management overview (Sponsored / Co-sponsored) (PDF - 0.38 Mb)
- Data management system validation (PDF - 0.23 Mb)
- Designing a case report form (PDF - 0.2 Mb)
- Statistical input in clinical trials (PDF - 0.17 Mb)
- Trial data management system maintenance and support (PDF - 0.24 Mb)
- Data backup, recovery and contingency
(PDF - 0.21 Mb) - Database lock and data extract authorisation (PDF - 0.25 Mb)
- Registration, randomisation, blinding and unblinding (PDF - 0.22 Mb)
- IMP management (PDF - 0.2 Mb)
- Monitoring and audit
- Trial end and archiving