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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.

PHARMACY SOPs

Title Number Version number Implementation date Related Documents
Actioning a Clinical Trial Investigational Medicinal Product Recall Pharm/S58 4.0 21st December 2017 Pharm/F41, Pharm/F49
Clinical Trials Task List Pharm/S80 2.0 28th June 2017 Pharm/F90
Clinical Trials Wardlist Check Instructions Pharm/S97 2.0 21st December 2017 Pharm/F102
Creating, reviewing and approving clinical trial accountability logs Pharm/S103 2.0 10th July 2017 Pharm/T36, Pharm/T37, Pharm/T38
Creating, reviewing and approving a clinical trial prescription Pharm/S88 2.0 21st December 2017 Pharm/T15
Destruction of Investigational Medicinal Product Pharm/S57 4.0 19th December 2017 Pharm/F44
Documenting, managing and reporting deviations Pharm/S104 2.0 25th March 2019 Pharm/F107
Expiry date Extensions and Re-labelling of IMPs Pharm/S51 2.0 8th March 2019 Pharm/F117
How to procure an Investigational Medicinal Product Pharm/S43 2.0 14th September 2015 None
Maintenance of the Clinical Trials List Pharm/S61 5.0 18th October 2017 None
Managing Code Break Procedures Pharm/S54 4.0 19th December 2017 Pharm/F25, Pharm/F26, Pharm/F27, Pharm/F50, Pharm/F53
Maintaining the blind for clinical trials in Pharmacy pharm/S89 2.0 8th April 2019 None
Maintaining Pharmacy Clinical Trial Files Pharm/S39 2.0 6th March 2019 None
Out of hours access to clinical trials protocols and investigator brochures in pharmacy Pharm/S106 2.0 28th February 2018 Pharm/F111
Pharmacy Financial Agreements and Invoicing Pharm/S42 5.0 8th March 2019 Pharm/T14
Pharmacy preparation for MHRA GCP Inspection Pharm/S99 2.0 25th March 2019 None
Preparation, Review and Approval of Pharmacy Trial Instructions Pharm/S50 3.0 8th February 2016 Pharm/T25, Pharm/T39, Pharm/T40, Pharm/T42, Pharm/T43
Prescribing and processing clinical trial prescriptions involving the satellite unit (York Hospital) Pharm/S92 1.0 14th September 2015 None
Production & Control of Clinical Trials Labels Pharm/S105 2.0 31st July 2017 Pharm/F33, Pharm/F34, Pharm/F40, Pharm/F104, Pharm/F105
Production & Control of Clinical Trials Labels Pharm/S105 3.0 29th November 2019 Pharm/F33, Pharm/F34, Pharm/F104, Pharm/F105
Publishing Clinical Trial Standard Operating Procedures on Q-Pulse Pharm/S60 3.0 19th December 2017 None
Quarantine of IMP Pharm/S59 5.0 6th March 2019 Pharm/F42, Pharm/F43
Quarantine of IMP Pharm/S59 6.0 9th December 2019 Pharm/F42, Pharm/F43
Receipt and Review of Amendments in Pharmacy Pharm/S79 3.0 24th May 2018 Pharm/F94
Receiving Clinical Trials Materials and Investigational Medicinal Products into Pharmacy Stores Pharm/S46 6.0 18th June 2018 Pharm/F35
Recording and monitoring of dispensing errors in clinical trials Pharm/S87 2.0 21st December 2017 Pharm/F29, Pharm/F30
Returning Clinical Trial Materials and Investigational Medicinal Products to the Trial Sponsor Pharm/S55 6.0 4th March 2019 None
Setting up a Clinical Trial Pharm/S45 1.0 31st July 2017 Pharm/T25, Pharm/T30, Pharm/T50, Pharm/14
Standards for prescribing Investigational Medicinal Products and Non-Investigational Medicinal Products for clinical trials Pharm/S33 2.0 13th December 2017 None
Stock Management of IMP in Pharmacy Pharm/S70 5.0 19th December 2017 Pharm/F57, Pharm/F67, Pharm/F68, Pharm/F98, Pharm/F99, Pharm/F100
Storage of Clinical Trials Materials and Investigational Medicinal Products Pharm/S47 5.0 22nd April 2019 None
Storage and dispensing of Investigational Medicinal Products outside of Pharmacy Pharm/S76 2.0 12th April 2015 Pharm/F89, Pharm/F91, Pharm/F92, Pharm/F93, Pharm/F97
Temperature Monitoring (Clinical Trials) Pharm/S48 7.0 5th February 2018 Pharm/F78, Pharm/F79, Pharm/F108
The Pharmacy Clinical Trial File Pharm/S44 4.0 15th April 2019 Pharm/F52
Training of Pharmacy Personnel Pharm/S49 4.0 18th March 2019 Pharm/F61, Pharm/F115, Pharm/F116
Trial Closedown in Pharmacy Pharm/S56 4.0 8th March 2019 Pharm/F87
Pharmacy Team - Signing onto the Study-Specific Delegation Logs Pharm/S95 1.0 5th November 2019 None

PHARMACY FORMS

Title Number Version number Implementation date Related SOP
Assessing an area for Investigational Medicinal Product storage outside of Pharmacy Pharm/F89 2.0 26th July 2016 Pharm/S76
Certificate of Destruction Pharm/F44 4.0 19th December 2017 Pharm/S57
Clinical Trials Monthly Stock Check Form Pharm/F63 5.0 19th December 2017 Pharm/S70
Clinical Trial Patient Log Pharm/F38 2.0 20th February 2019 Pharm/S45
Clinical Trials Task List Form Pharm/F90 2.0 28th June 2017 Pharm/S80
Clinical Trials Training package & Competency Workbook Pharm/F115 2.0 18th March 2019 Pharm/S49
Code Break Test Form Pharm/F50 5.0 20th February 2019 Pharm/S54
Daily Clinical Trials Temperature Checks Pharm/F108 2.0 5th February 2018 Pharm/S48
Deviation Assessment Form Pharm/F107 2.0 25th March 2019 Pharm/S104
Distribution of Code Break Envelopes Form Pharm/F27 4.0 31st July 2017 Pharm/S54
Expiry Date Re-Labelling Worksheet Pharm/F117 2.0 8th March 2019 Pharm/S51
IMP Recall Test Form Pharm/F49 4.0 21st December 2017 Pharm/S58
Introduction to Pharmacy Clinical Trials - Short course training package Pharm/F116 1.0 18th March 2019 Pharm/S49
Label Accountability Form Pharm/F104 2.0 31st July 2017 Pharm/S105
Master Label Form Pharm/F33 4.0 31st July 2017 Pharm/S105
Master Label Amendment Form Pharm/F34 3.0 31st July 2017 Pharm/S105
Pharmacy Clinical Trials File Contents Pharm/F52 5.0 18th June 2018 Pharm/S44
Pharmacy Closedown Form Pharm/F87 1.0 8th March 2019 Pharm/S56
Pharmacy Monitoring Form Pharm/F97 1.0 12th April 2015 Pharm/S76
Pharmacy Training Log Pharm/F61 5.0 8th March 2019 Pharm/S49
Pharmacy Clinical Trials Maintenance Form Pharm/F82 2.0 6th March 2019 Pharm/S39
Pharmacy Personnel Log Pharm/F39 2.0 20th February 2019 Pharm/S45
Pharmacy Clinical Trial Set up Form Pharm/F14 1.0 31st July 2017 Pharm/S45
Pharmacy Clinical Trials Wardlist Check Form Pharm/F102 2.0 21st December 2017 Pharm/S97
Pharmacy Clinical Trials - Dispensing Errors Reporting Log and Codes Pharm/F29 2.0 21st December 2017 Pharm/S87
Production of Code break Envelopes Form Pharm/F25 4.0 31st July 2017 Pharm/S54
Quarantine Notice Pharm/F42 5.0 18th June 2018 Pharm/S59
Quarantine Notice Pharm/F42 6.0 29th November 2019 Pharm/S59
Quarantine Log Pharm/F43 5.0 18th June 2018 Pharm/S59
Receipt of Code Break Envelopes Form Pharm/F26 4.0 31st July 2017 Pharm/S54
Receipt and Review of Amendments in Pharmacy Form Pharm/F94 3.0 24th May 2018 Pharm/S79
Record of Labels Printed Pharm/F105 2.0 31st July 2017 Pharm/S105
Record of access to a clinical trial protocol and/or investigator brochure Pharm/F111 2.0 28th February 2018 Pharm/S106
Stores Receipt Form Pharm/F35 5.0 18th June 2018 Pharm/S46
Temperature Excursion Record Form (Clinical Trials) Pharm/F79 3.0 20th February 2019 Pharm/S48
Trial Drug Recall Summary Sheet Pharm/F41 4.0 21st December 2017 Pharm/S58
Transfer of IMP from Pharmacy to a storage location outside of Pharmacy Pharm/F91 2.0 26th July 2016 Pharm/S76
Transer of unused IMP from a storage location outside of Pharmacy to Pharmacy Pharm/F92 2.0 26th July 2016 Pharm/S76
Transfer of patient returned/used IMP from a storage location outside of Pharmacy to Pharmacy Pharm/F93 3.0 26th July 2016 Pharm/S76

PHARMACY TEMPLATES 

Title Number Version number Implementation date Related SOP
Accuracy and Clinical Checklist Template Pharm/T43 2.0 19th February 2019 Pharm/S50
Clinical Trial Prescription Template Pharm/T15 2.0 21st December 2017 Pharm/S88
Dispensing Instructions Template Pharm/T42 2.0 19th February 2019 Pharm/S50
Letter Template - Study Set-Up Feasibility Pharm/T25 1.0 31st July 2017 Pharm/S45
Letter Template - Study Set-Up Review & Authorisation Pharm/T30 1.0 31st July 2017 Pharm/S45
Letter Template - Study Set-Up Pharmacy Readiness Pharm/T49 2.0 20th February 2019 Pharm/S45
Letter Template - Study Set-Up Pharmacy Green Light Pharm/T50 2.0 20th February 2019 Pharm/S45
Pharmacy Invoice Template Pharm/T14 4.0 18th June 2018 Pharm/S42
Template master accountability log (double blind trial) Pharm/T36 2.0 10th July 2017 Pharm/S103
Template master accountability log (open label trial) Pharm/T37 2.0 10th July 2017 Pharm/S103
Template participant specific accountability log Pharm/T38 2.0 10th July 2017 Pharm/S103
Trial Stock Management Instruction Template Pharm/T39 2.0 19th February 2019 Pharm/S50
Trial Details and Summary Template Pharm/T40 2.0 19th February 2019 Pharm/S50

1st April 2016 to 31st March 2017

York and Scarborough

147 research studies open to recruitment

=

4588 patients recruited into clinical trials