Standard operating procedures (SOPs)
For any queries relating to SOPs inlcuding submitting clinical research studies at a Trial Feasibility Committee SOP or sponsorship, please contact rf.randd@nhs.net as these SOPs are currently under review.
General guidance and useful tools:
Regulatory approvals (Health Research Authority and Research Ethics Committee) visit.
Is my study research? Visit
Do I need NHS ethics? visit
Standard operating procedures
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Approved: 04/03/2020
SOP001 Production, approval and review of SOPs V2.1 01_DEC_2018
.pdf (271 KB)
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Approved: 04/03/2020
SOP002 Research Placement Agreements, LOA and CPA for external staff V2.6 14_MAY_2019
.pdf (386 KB)
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SOP004 Training Records V2.0_04 OCT 2017
.pdf (411 KB)
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Approved: 05/03/2020
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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Approved: 05/03/2020
SOP007 Informed Consent Adults V2.0_04 OCT 2017
.pdf (303 KB)
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Approved: 05/03/2020
SOP009 Informed Consent Adults who lack Capacity V2.0_09 OCT 2017
.pdf (314 KB)
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Approved: 05/03/2020
SOP011 Recruitment V2.0_16 NOV 2017
.pdf (305 KB)
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Approved: 05/03/2020
SOP014 Contract negotiation and review V2.0_30 NOV 2017
.pdf (379 KB)
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Approved: 05/03/2020
SOP016 Amendments for RFL Sponsored Studies V2.0_04 OCT 2017
.pdf (462 KB)
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Approved: 05/03/2020
SOP019 Investigator Site File V2.0_04 OCT 2017
.pdf (530 KB)
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Approved: 10/03/2020
SOP021 Delegation Log V2.0_04 OCT 2017
.pdf (480 KB)
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Approved: 10/03/2020
SOP023 Version control of study documents V2.0_04 OCT 2017
.pdf (271 KB)
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Approved: 10/03/2020
SOP024 File Notes V2.0_04 OCT 2017
.pdf (385 KB)
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Approved: 10/03/2020
SOP026 Site Selection and initiation for RF Sponsored Studies V2.0_26 SEPT 2017
.pdf (333 KB)
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Approved: 10/03/2020
SOP029_Applying_for_Sponsorship v2.0_29_MAR_2018
.pdf (421 KB)
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Approved: 10/03/2020
SOP030 Study Close-Down v2.2 27 JAN 2020
.pdf (505 KB)
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Approved: 10/03/2020
SOP032 Non compliance V3.1_05_MAR_2019
.pdf (516 KB)
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Approved: 10/03/2020
SOP033 Reporting of Serious Breaches of GCP V2.0_26 SEPT 2017
.pdf (398 KB)
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Approved: 10/03/2020
SOP034 Misconduct in research V2.0_03 OCT 2017
.pdf (285 KB)
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Approved: 10/03/2020
SOP044 Archiving V2.3_11NOV 2019
.pdf (291 KB)
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Approved: 10/03/2020
SOP047 Research Audits and Inspections V2.0_07 OCT 2017
.pdf (506 KB)
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Approved: 10/03/2020
SOP048 Submitting Studies at TFC V2.1_10 SEPT 2019
.pdf (702 KB)
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Approved: 10/03/2020
SOP049 Assessing Costs of RF Research studies V2.1_10-SEPT_2019
.pdf (329 KB)
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Approved: 10/03/2020
SOP051 Confirmation of capacity and capability for non Harmonised Studies V1.1_10 SEPT 2019
.pdf (574 KB)
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Approved: 10/03/2020
SOP052 Confirmation of capacity and capability for Harmonised Studies V1.1_ 10 SEPT 2019
.pdf (574 KB)
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Approved: 10/03/2020
SOP053 Applying for NIHR Adoption V1.0_18 SEPT 2017
.pdf (290 KB)
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Approved: 10/03/2020
SOP054 Preparation and maintenance of the TMF V1.1_19 OCT 2018
.pdf (379 KB)
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Approved: 10/03/2020
SOP055 Peer Review V1.2 01_DEC_2018
.pdf (380 KB)
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Approved: 10/03/2020
SOP056 Annual Progress Reports APR V1.1 19 OCT 2018
.pdf (361 KB)
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Approved: 10/03/2020
SOP057 Transfer of Sponsorship V1.0_18 SEPT 2017
.pdf (359 KB)
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Approved: 10/03/2020
SOP058 Research Data V1.0_04 OCT 2017
.pdf (400 KB)
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Approved: 10/03/2020
SOP059 Laboratory procedures V1.0_26 SEPT 2017
.pdf (277 KB)
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Approved: 10/03/2020
SOP060 Change management V1.0_09 OCT 2017
.pdf (200 KB)
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Approved: 10/03/2020
SOP061 Escalation V1.0_16 OCT_2017
.pdf (343 KB)
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Approved: 10/03/2020
SOP062 Safety Reporting for non CTIMPs V2.2 30_JAN_2019
.pdf (547 KB)
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Approved: 10/03/2020
SOP063 Safety Reporting for CTIMPS hosted at RF V1_07 NOV 2017
.pdf (789 KB)
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Approved: 10/03/2020
SOP067 Safety Reporting for Medical Device Studies V1.0_28 Jan 2019
.pdf (366 KB)