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
.1_01_dec_2018 (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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SOP006 Roles and responsibilities V2.0_10 NOV 2017
.pdf (468 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_11_NOV_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
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
SOP067_Safety_Reporting_for_Medical_Device_Studies_V1.0_28_Jan_2019
.pdf (366 KB)