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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 - 0.29 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
Informed consent (PDF - 0.28 Mb)
Participant information (PDF - 0.28 Mb)
Trial master file (PDF - 0.18 Mb)
Version control of study documents (PDF - 0.22 Mb)
Trial conduct
Amendments to NHS research study (PDF - 0.21 Mb)
Management of healthy volunteers in research
Pharmacovigilance and regulatory
Adverse event reporting (Sponsored/ Co-sponsored) (PDF - 0.5 Mb)
Management of source data (PDF - 0.24 Mb)
Serious-breaches (Sponsored / Co-sponsored) (PDF - 0.37 Mb)
DSURs sponsored
(PDF - 0.28 Mb)
Urgent Safety Measures
(PDF - 0.32 Mb)
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
Audit and inspection (PDF - 0.27 Mb)
Exiting staff procedure (PDF - 0.17 Mb)
Monitoring (PDF - 0.22 Mb)
Quality Management Systems (PDF - 0.43 Mb)
Sponsor oversight (PDF - 0.15 Mb)
Trial end and archiving
Archiving essential documents (PDF - 0.33 Mb)
End of trial procedures (PDF - 0.24 Mb)
