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SOPs and Guidance

Standard Operating Procedures for Labs

SOPs

Title  Number   Version Number Implementation Date Related Documents
Archiving of Laboratory Research Files R&D/S34 3.0 24th April 2023 None
Laboratory Research Clinical Trial Set-Up R&D/S35 3.0 13th February 2023 &D/F13, R&D/F28, R&D/F31, R&D/F32, R&D/F51, R&D/F53, R&D/F62, R&D/F72, R&D/T07, R&D/T09
Processing Amendments in the Laboratory Research Team R&D/S78 2.0 21st September 2022 R&D/F23
Processing Laboratory Research Samples R&D/S94 4.0 16th September 2021 R&D/T60
R&D Laboratory Connected Automated Monitoring and Temperature Monitoring System R&D/S41 3.0 16th August 2023 None
Training Manual & Competencies for Research HSAP R&D/S86 2.0 16th August 2022 None
Use of the R&D Laboratory Centrifuges R&D/S84 2.0 16th August 2022 R&D/F75

Forms 

Title     Number Version Number Implementation Date  Related SOP
Centrifuge Maintenance Log R&D/F85 3.0 16th August 2022 R&D/S84
Histopathology Specimen Log R&D/F53 2.0 12th August 2019 R&D/S35
Laboratory Investigator Site File (ISF) Audit R&D/F13 3.0 13th February 2023 R&D/S35
Laboratory Amendment Log R&D/F23 1.0 16th October 2017 R&D/S78
Laboratory Research Clinical Trial Set Up Form R&D/F73 4.0 31st August 2020 R&D/S35
Specimen Destruction Log R&D/F28 1.0 23rd October 2017 R&D/S35
Self-assessment of GCP compliance within the Laboratory R&D/F30 1.0 22nd January 2018 R&D/S94
Specimen Deviation Log R&D/F31 3.0 12th August 2019 R&D/S35
Specimen Location Log R&D/F32 2.0 12th August 2019 R&D/S35
Specimen Receipt Log R&D/F51 2.0 12th August 2019 R&D/S35
Specimen Shipping Log R&D/F62 2.0 12th August 2019 R&D/S35
Specimen Incubation Log R&D/F74 2.0 31st August 2020 R&D/S35
Staff Signature & Training Log R&D/F72 1.0 23rd October 2017 R&D/S35

Templates 

Title Number      Version Number Implementation Date Related SOP 
Competency Assessment for the Preparation of Blood Smears R&D/T49 1.0 28th March 2022 None
Histopathology Site File Contents Page R&D/T63 1.0 23rd May 2018 R&D/S35
Laboratory Site File Contents Page R&D/T07 2.0 2nd October 2019 R&D/S35
Laboratory Research Equipment Maps                      R&D/T35  1.0 5th January 2018 R&D/S94
Spine Template R&D/T09 2.0 2nd October 2019 R&D/S35
Storage Box Sample Location Log R&D/T60 2.0 12th August 2019 R&D/S94

Guidance Documents

Title Number Version Number Implementation Date
Change to eGFR Calculation - April 2019                          R&D/G09     1.0 17th April 2019
Analyte Reference Interval R&D/G10 3.0 1st October 2020

1st April 2023 – 31st March 2024

York & Scarborough

50 research studies open to recruitment

=

3246 patients recruited into clinical trials