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Research
Management and strategy
Ethics and research integrity
CTSN
Standard Operating Procedures (SOPs)
Standard Operating Procedures (SOPs)
Study set up
Obtaining sponsorship for research studies (PDF - 0.39 Mb)
Research applications (PDF - 0.4 Mb)
Research staff training (PDF - 0.61 Mb)
Risk assessment and risk rating (PDF - 0.42 Mb)
Study initiation (PDF - 0.3 Mb)
Vendor assessment (PDF - 0.47 Mb)
Writing research protocols (PDF - 0.44 Mb)
Trial documentation
Informed consent (PDF - 0.33 Mb)
Participant information (PDF - 0.48 Mb)
Trial master file (PDF - 0.6 Mb)
Version control of study documents (PDF - 0.25 Mb)
Trial conduct
Amendments to NHS research study (PDF - 0.23 Mb)
Management of healthy volunteers in research
Risk adapted management of ctimps (PDF - 0.34 Mb)
Pharmacovigilance and regulatory
Adverse event reporting (Sponsored/ Co-sponsored) (PDF - 1 Mb)
Management of source data (PDF - 0.39 Mb)
Serious-breaches (Sponsored / Co-sponsored) (PDF - 0.33 Mb)
Data management and statistics
Completing a case report form (Sponsored / Co-sponsored) (PDF - 0.2 Mb)
Data management overview (Sponsored / Co-sponsored) (PDF - 0.56 Mb)
Data management system validation (PDF - 0.33 Mb)
Designing a case report form (PDF - 0.24 Mb)
Statistical input in clinical trials (PDF - 0.21 Mb)
Trial data management system maintenance and support (PDF - 0.23 Mb)
Monitoring and audit
Audit and inspection (PDF - 0.41 Mb)
Exiting staff procedure (PDF - 0.28 Mb)
Monitoring (PDF - 0.55 Mb)
Quality Management Systems (PDF - 0.43 Mb)
Sponsor oversight (PDF - 0.3 Mb)
Trial end and archiving
Archiving essential documents (PDF - 0.41 Mb)
End of trial study reports (PDF - 0.12 Mb)
Trial closure (PDF - 0.43 Mb)
