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SOPs and Guidance

Pharmacy SOPS, Forms and Templates

All Pharmacy SOPs are scheduled for review every 3 years.

Users of the SOPs are reminded that all members of staff have a responsibility to identify changes in policy, legislation and procedures that affect SOPs and for bringing this to the attention of the SOP Controller. If any user identifies any Pharmacy SOPs that require review they should complete a review form and send this to the SOP Controller.


Title Number Version number Implementation date Related Documents
Actioning a Clinical Trial Investigational Medicinal Product Recall Pharm/S58 6.0 14th February 2024 Pharm/F41, Pharm/F49
Clinical Trials Fridge/Freezer Cleaning Pharm/S96 2.0 21st February 2024 Pharm/F40
Clinical Trials Ultra Low Freezer Pharm/S108 1.0 15th March 2022 None
Clinical Trials Wardlist Check Instructions Pharm/S97 4.0 21st February 2024 Pharm/F102
Clinical Trial Prescription Risk Assessment: Professional Verification & Final Check of Clinical Trial Prescription Pharm/S73 2.0 21st February 2024 Pharm/F04
Creating, reviewing and approving clinical trial accountability logs Pharm/S103 4.0 14th February 2024 Pharm/T36, Pharm/T37, Pharm/T38
Creating, reviewing and approving a clinical trial prescription Pharm/S88 3.0 11th January 2021 Pharm/T15
Destruction of Investigational Medicinal Product Pharm/S57 5.0 24th December 2019 Pharm/F44
Documenting, managing and reporting deviations Pharm/S104 3.0 27th July 2022 Pharm/F107
Expiry Date Extensions and Re-labelling of IMPs Pharm/S51 3.0 26th July 2022 Pharm/F117
How to Procure an Investigational Medicinal Product for a Trust Sponsored Study Pharm/S43 3.0 31st August 2020 None

Maintenance of the Clinical Trials List and collection of KPI data for Pharmacy Clinical Trials

Pharm/S61 8.0 19th June 2023 F24
Managing Code Break Procedures Pharm/S54 5.0 3rd September 2020 Pharm/F25, Pharm/F26, Pharm/F27, Pharm/F50
Maintaining the blind for clinical trials in Pharmacy Pharm/S89 3.0 11th July 2023 None

Maintaining Pharmacy Clinical Trials Files

Pharm/S39 4.0 11th January 2021 Pharm/F82, Pharm/F84, Pharm/F87
Out of hours access to clinical trials protocols and investigator brochures Pharm/S106 4.0 21st February 2024 Pharm/F111
Pharmacy Financial Agreements and Invoicing Pharm/S42 6.0 26th July 2022 Pharm/T14
Pharmacy Preparation for MHRA GCP Inspection Pharm/S99 3.0 26th May 2022 None
Preparation, Review and Approval of Pharmacy Trial Instructions Pharm/S50 5.0 14th February 2024 Pharm/T16, Pharm/T25, Pharm/T39, Pharm/T40, Pharm/T42, Pharm/T43
Prescribing and processing clinical trial prescriptions involving the satellite unit (York Hospital) Pharm/S92 2.0 11th August 2020 F84
Production & Control of Clinical Trials Labels Pharm/S105 5.0 21st February 2024 Pharm/F33, Pharm/F34, Pharm/F105
Publishing Clinical Trial Standard Operating Procedures on Q-Pulse Pharm/S60 4.0 11th January 2021 None
Quarantine of IMP Pharm/S59 7.0 2nd November 2020 Pharm/F42, Pharm/F43
Receipt and Review of Amendments in Pharmacy Pharm/S79 4.0 25th February 2021 Pharm/F94
Receiving Clinical Trials Materials and Investigational Medicinal Products into Pharmacy Stores Pharm/S46 8.0 21st February 2024


Recording and monitoring of dispensing errors in clinical trials Pharm/S87 3.0 5th January 2021 Pharm/F29
Returning Clinical Trials Materials and Investigational Medicinal Products to the Trial Sponsor Pharm/S55 7.0 27th July 2022 None
Setting up a Clinical Trial Pharm/S45 3.0 30th March 2022 Pharm/F14, F38, F39
Standards for prescribing Investigational Medicinal Products and Non-Investigational Medicinal Products for clinical trials Pharm/S33 4.0 21st February 2024 None
Stock Management of IMP in Pharmacy Pharm/S70 7.0 21st February 2024 Pharm/F63
Storage of Clinical Trials Materials and Investigational Medicinal Products Pharm/S47 6.0 3rd January 2023 None
Storage and dispensing of Investigational Medicinal Products outside of Pharmacy Pharm/S76 3.0 20th December 2019 Pharm/F89, Pharm/F91, Pharm/T53
Temperature Monitoring (Clinical Trials) Pharm/S48 10.0 23rd February 2022 Pharm/F79, Pharm/F108, Pharm/F109
The Pharmacy Clinical Trial File Pharm/S44 6.0 28th October 2020 Pharm/F52, Pharm/F35
Training of Pharmacy Personnel Pharm/S49 5.0 26th May 2022 Pharm/F61, Pharm/F115, Pharm/F116
Trial Closedown in Pharmacy Pharm/S56 6.0 11th January 2021 Pharm/F87, Pharm/F82, R&D/F56, R&D/S11
Pharmacy Team - Signing onto the Study-Specific Delegation Logs Pharm/S95 2.0 13th February 2023 None
Delivering Clinical Trials Prescriptions to Patient's Homes under exceptional circumstances Pharm/S101 1.0 8th April 2020 F92


Title Number Version number Implementation date Related SOP
Assessing an area for Investigational Medicinal Product Storage outside of Pharmacy Pharm/F89 4.0 13th February 2023 Pharm/S76
Certificate of Destruction Pharm/F44 6.0 13th February 2023 Pharm/S57
Clinical Trials Fridge/Freezer Cleaning Schedule Pharm/F40 2.0 28th December 2022 Pharm/S96
Clinical Trials Fridge/Freezer Cleaning Schedule Pharm/F40 3.0 21st February 2024 Pharm/S96
Clinical Trials Monthly Stock Check Form Pharm/F63 7.0 21st February 2024 Pharm/S70
Clinical Trial Patient Log Pharm/F38 3.0 30th March 2022 Pharm/S45
Clinical Trials Temperature Logger Sign-Out Form Pharm/F109 1.0 29th March 2021 Pharm/S48
Clinical Trials Training package & Competency Workbook Pharm/F115 3.0 26th October 2021 Pharm/S49
Clinical Trials Prescription Risk Assessment Form Pharm/F04 2.0 21st February 2024 Pharm/S73
Code Break Test Form Pharm/F50 6.0 3rd September 2020 Pharm/S54
Daily Clinical Trials Temperature Checks Pharm/F108 3.0 22nd February 2021 Pharm/S48
Deviation Assessment Form Pharm/F107 3.0 26th July 2022 Pharm/S104
Distribution of Code Break Envelopes Form Pharm/F27 5.0 3rd September 2020 Pharm/S54
Expiry Date RE-Labelling Worksheet Pharm/F117 3.0 26th July 2022 Pharm/S51
IMP Recall Test Form Pharm/F49 6.0 14th February 2024 Pharm/S58
Introduction to Pharmacy Clinical Trials - Short course training package Pharm/F116 2.0 26th October 2021 Pharm/S49
Master Label Form Pharm/F33 6.0 21st February 2024 Pharm/S105
Master Label Amendment Form Pharm/F34 50 21st February 2024 Pharm/S105
Pharmacy Clinical Trials File Contents Pharm/F52 6.0 12th October 2020 Pharm/S44
Pharmacy Closedown Form Pharm/F87 2.0 11th January 2021 Pharm/S56
Pharmacy Training Log Pharm/F61 6.0 15th April 2022 Pharm/S49
Pharmacy Clinical Trials Maintenance Form Pharm/F82 5.0 11th July 2023 Pharm/S39
Pharmacy Clinical Trials Monthly Dispensing Collection Sheet Pharm/F24 1.0 13th January 2021 Pharm/S61
Pharmacy Personnel Log Pharm/F39 3.0 30th March 2022 Pharm/sS45
Pharmacy Clinical Trial Set Up Form Pharm/F14 3.0 30th March 2022 Pharm/S45
Pharmacy Clinical Trials Wardlist Check Form Pharm/F102 5.0 21st February 2024 Pharm/S97
Pharmacy Clinical Trials - Dispensing Errors Reporting Log and Codes Pharm/F29 3.0 5th January 2021 Pharm/S87
Pharmacy Trial Instructions Version Control Form Pharm/F35 1.0 28th October 2020 Pharm/S44
Production of Code Break Envelopes Form Pharm/F25 5.0 3rd September 2020 Pharm/S54
Quarantine Notice Pharm/F42 7.0 2nd November 202 Pharm/S59
Quarantine Log Pharm/F43 6.0 2nd November 2020 Pharm/S59
Receipt of Code Break Envelopes Form Pharm/F26 5.0 3rd September 2020 Pharm/S54
Receipt and Review of Amendments in Pharmacy Form Pharm/F94 4.0 25th February 2021 Pharm/S79
Record of Labels Printed Pharm/F105 5.0 21st February 2024 Pharm/S105
Record of access to a clinical trial protocol and/or investigator brochure Pharm/F111 4.0 21st February 2024 Pharm/S106
Temperature Excursion Record Form (Clinical Trials) Pharm/F79 4.0 11th April 2022 Pharm/S48
Trial Drug Recall Summary Sheet Pharm/F41 6.0 14th February 2024 Pharm/S58
Transfer of IMP from Pharmacy to a storage location outside of Pharmacy Pharm/F91 4.0 13th February 2023 Pharm/S76
Clinical Trials Delivery Form Pharm/F92 1.0 8th April 2020 Pharm/S101

Transporting IMP between York and Scarborough Sites Form

Pharm/F84 1.0 11th August 2020 Pharm/S92


Title Number Version number Implementation date Related SOP
Accuracy and Clinical Checklist Template Pharm/T43 2.0 19th February 2019 Pharm/S50
Additional Pharmacy Process SOP Template Pharm/T16 2.0 14th February 2024 Pharm/S50
Clinical Trial Prescription Template Pharm/T15 3.0 11th January 2021 Pharm/S88
Dispensing Instructions Template Pharm/T42 3.0 30th March 2022 Pharm/S50
Pharmacy Invoice Template Pharm/T14 7.0 10th October 2023 Pharm/S42
Template master accountability log (double blind trial) Pharm/T36 4.0 14th February 2024 Pharm/S103
Template master accountability log (open label trial) Pharm/T37 4.0 14th February 2024 Pharm/S103
Template participant specific accountability log Pharm/T38 4.0 14th February 2024 Pharm/S103
Trial Stock Management Instruction Template Pharm/T39 3.0 30th March 2022 Pharm/T39
Trial Details and Summary Template Pharm/T40 3.0 11th April 2022 Pharm/S50
Trial Specific Pharmacy Monitoring Visit Form Template Pharm/T53 2.0 15th March 2021 Pharm/S76

1st April 2023 – 31st March 2024

York & Scarborough

50 research studies open to recruitment


3246 patients recruited into clinical trials