Standard operating procedures (SOPs)
General guidance and useful tools:
Regulatory approvals (Health Research Authority and Research Ethics Committee)
http://www.hra.nhs.uk/
Is my study research?
http://www.hra-decisiontools.org.uk/research/redirect.html
Do I need NHS ethics?
http://hra-decisiontools.org.uk/ethics/
Standard operating procedures
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Approved: 23/04/2018
SOP001 Production, approval and review of SOPs V2.0_07 SEPT 2017
.pdf (448 KB)
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SOP002 Research passports V2.0_16 NOV 2017
.pdf (455 KB)
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SOP003 Reporting Amendments V2.0_04 OCT 2017
.pdf (414 KB)
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SOP004 Training Records V2.0_04 OCT 2017
.pdf (411 KB)
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SOP005 GCP Training V2.0_04 OCT 2017
.pdf (420 KB)
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SOP006 Roles and responsibilities V2.0_10 NOV 2017
.pdf (468 KB)
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SOP007 Informed Consent Adults V2.0_04 OCT 2017
.pdf (303 KB)
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SOP008 Informed Consent Children V2.0_06 OCT 2017
.pdf (397 KB)
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SOP009 Informed Consent Adults who lack Capacity V2.0_09 OCT 2017
.pdf (314 KB)
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SOP011 Recruitment V2.0_16 NOV 2017
.pdf (305 KB)
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SOP014 Contract negotiation and review V2.0_30 NOV 2017
.pdf (379 KB)
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SOP016 Amendments for RFL Sponsored Studies V2.0_04 OCT 2017
.pdf (462 KB)
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SOP019 Investigator Site File V2.0_04 OCT 2017
.pdf (530 KB)
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SOP021 Delegation Log V2.0_04 OCT 2017
.pdf (480 KB)
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Approved: 03/10/2017
SOP 022 Case Report Forms Design for RFL sponsored studies
.pdf (413 KB)
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SOP023 Version control of study documents V2.0_04 OCT 2017
.pdf (271 KB)
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SOP024 File Notes V2.0_04 OCT 2017
.pdf (385 KB)
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Approved: 03/10/2017
SOP 025 sponsor files
.pdf (374 KB)
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SOP026 Site Selection and initiation for RF Sponsored Studies V2.0_26 SEPT 2017
.pdf (333 KB)
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SOP 029 Applying for Sponsorship v2.0 29 MAR2018
.pdf (388 KB)
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SOP030 Study Close down V2.0_04 OCT 2017
.pdf (397 KB)
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Approved: 03/10/2017
SOP 031 Adverse Event Reporting
.pdf (692 KB)
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SOP032 Non compliance V2.0_03 OCT 2017
.pdf (403 KB)
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SOP033 Reporting of Serious Breaches of GCP V2.0_26 SEPT 2017
.pdf (398 KB)
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SOP034 Misconduct in research V2.0_03 OCT 2017
.pdf (285 KB)
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Approved: 03/10/2017
SOP 037 Data cleaning and database lockdown
.pdf (387 KB)
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Approved: 03/10/2017
SOP 038 Study data CRFs and source data
.pdf (393 KB)
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Approved: 03/10/2017
SOP 042 Research data management for RFL sponsored studies
.pdf (386 KB)
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SOP044 Archiving V2.0_04 OCT 2017
.pdf (407 KB)
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SOP047 Research Audits and Inspections V2.0_07 OCT 2017
.pdf (506 KB)
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Approved: 03/10/2017
SOP 048 Submitting Clinical Research Studies for Review at a TFC
.pdf (493 KB)
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SOP049 Assessing Costs of RF Research studies V2.0_30 NOV 2017
.pdf (433 KB)
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SOP051 Confirmation of capacity and capability for non Harmonised Studies V1.0_07 SEPT 2017
.pdf (464 KB)
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SOP052 Confirmation of capacity and capability for Harmonised Studies V1.0_ 22 FEB 2018
.pdf (449 KB)
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SOP048 Submitting Clincial Research Studies at a Trial Feasibility Committee 2.0 29_MAR_2018
.pdf (501 KB)
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SOP053 Applying for NIHR Adoption V1.0_18 SEPT 2017
.pdf (290 KB)
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SOP054 Preparation and maintenance of the TMF V1.0_19 SEPT 2017
.pdf (276 KB)
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SOP055 Peer Review V1.0 16_OCT_2017
.pdf (282 KB)
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SOP056 Annual Progress Reports APR V1.0_19 SEPT 2017
.pdf (276 KB)
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SOP057 Transfer of Sponsorship V1.0_18 SEPT 2017
.pdf (359 KB)
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SOP058 Research Data V1.0_04 OCT 2017
.pdf (400 KB)
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SOP059 Laboratory procedures V1.0_26 SEPT 2017
.pdf (277 KB)
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SOP060 Change management V1.0_09 OCT 2017
.pdf (200 KB)
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SOP061 Escalation V1.0_16 OCT_2017
.pdf (343 KB)
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SOP062 Safety Reporting for non CTIMPs V1.0_30 JAN 2018
.pdf (355 KB)
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SOP063 Safety Reporting for CTIMPS hosted at RF V1_07 NOV 2017
.pdf (566 KB)