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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 1.0 16th October 2017 None
Laboratory Research Clinical Trial Set-Up  R&D/S35  1.0  9th November 2017  R&D/F24,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 1.0 16th October 2017  R&D/F23
Processing Laboratory Research Samples R&D/S94 2.0 8th April 2019 R&D/T60
R&D Laboratory Tutela Temperature Monitoring System R&D/S41 1.0 14th September 2018 None
Research and Development Use of the Beckman ALLEGRA-X12 Centrifuge R&D/S38 1.0 8th April 2019 R&D/F85
Research and Development Use of the Heraeus Megafuge 40R Centrifuge R&D/S84 1.0 8th April 2019 R&D/F85
Training Manual & Competencies for Research HSAP R&D/S86 1.0 15th October 2019 None

Forms 

Title     Number Version Number Implementation Date  Related SOP
Centrifuge Maintenance Log R&D/F85 2.0 8th April 2019 R&D/S38 & 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 2.0 2nd October 2019 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&F/F73 3.0 2nd October 2019 R&D/S35
Laboratory Site File Document Reference Log R&D/F76 1.0 9th November 2017 R&D/S35
Microbiology Specimen Log R&D/F36 1.0 21st August 2018 R&D/S94
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 1.0 9th November 2017 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 
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

1st April 2016 to 31st March 2017

York and Scarborough

147 research studies open to recruitment

=

4588 patients recruited into clinical trials