Saturday 23rd September 2017

York Foundation Trust R&D Unit

NHS

Contact us

For general enquiries please
contact:

PostYork Foundation Trust R&D Unit,
Learning and Research Centre,
York Hospital,
Wigginton Road,
York YO31 8HE


Telephone iconTelephone: 01904 726996


Fax iconFax: 01904 725700


Email iconEmail: research.governance
@york.nhs.uk

Pharmacy SOPS, Forms and Templates

SEE 'IMPORTANT SOP NEWS' ON THE 'SOPs AND GUIDANCE' PAGE

 

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
Actioning a Clinical Trial Investigational Medicinal Product Recall Pharm/S58 3.0 23rd November 2015
Creating, reviewing and approving clinical trial accountability logs Pharm/S103 2.0 10th July 2017
Creating, reviewing and approving a clinical trial prescription Pharm/S88 1.0 12th March 2015
Destruction of Investigational Medicinal Product Pharm/S57 3.0 27th July 2015
Pharmacy Financial Agreements and Invoicing Pharm/S42 4.0 12th April 2015
How to procure an Investigational Medicinal Product Pharm/S43 2.0 14th September 2015
Maintenance of the Trial Status Inventory Dispensary List Pharm/S61 4.0 19th October 2015
Managing Code Break Procedures Pharm/S54 3.0 20th August 2015
Expiry Date Monitoring (Clinical Trials) Pharm/S52 4.0 19th January 2016
Pharmacy preparation for MHRA GCP Inspection Pharm/S99 1.0 11th February 2015
Preparation, Review and Approval of Pharmacy Trial Instructions Pharm/S50 3.0 8th February 2016
Publishing Clinical Trial Standard Operating Procedures on Q-Pulse Pharm/S60 2.0 20th July 2015
Quarantine of IMP Pharm/S59 4.0 1st July 2015
Receipt and Review of Protocol Amendments in Pharmacy Pharm/S79 2.0 19th January 2016
Receiving Clinical Trial Materials and Investigational Medicinal Products into Pharmacy Stores Pharm/S46 5.0 28th October 2015
Returning Clinical Trial Materials and Investigational Medicinal Products to the Trial Sponsor Pharm/S55 5.0 15th June 2015
Standards for prescribing Investigational Medicinal Products and No Investigational Medicinal Products for clinical trials Pharm/S33 1.0 29th May 2015
Stock Management of IMP in Pharmacy Pharm/S70 3.0 2nd March 2015
Storage of Clinical Trials Materials and Investigational Medicinal Products Pharm/S47 4.0 19th January 2016
Storage and dispensing of Investigational Medicinal Products outside of Pharmacy Pharm/S76 2.0 12th April 2015
Temperature Monitoring (Clinical Trials) Pharm/S48 6.0 19th October 2015
The Pharmacy Clinical Trial File Pharm/S44 3.0 29th May 2015
Training of Pharmacy Personnel Pharm/S49 3.0 19th January 2016
Trial Closedown in Pharmacy Pharm/S56 3.0 20th August 2015
Production & Control of Clinical Trials Labels Pharm/S105 2.0 31st July 2017
Clinical Trials Wardlist Check Instructions Pharm/S97 1.0 20th August 2015
Recording and monitoring of dispensing errors in clinical trials Pharm/S87 1.0 20th August 2015
Maintaining the blind for clinical trials in Pharmacy Pharm/S89 1.0 20th August 2015
Prescribing and processing clinical trial prescriptions involving the satellite unit (York Hospital) Pharm/S92 1.0 14th September 2015
Out of Hours Access to Clinical Trial Protocols and Investigator Brochures in Pharmacy Pharm/S106 1.0 12th November 2015
Documenting, managing and reporting deviations Pharm/S104 1.0 23rd December 2015
Completion and Analysis of the Prescription Audit Tracker (Clinical Trials) Pharm/S101 2.0 1st March 2016
Clinical Trials Task List Pharm/S80 2.0 28th June 2017
Maintaining Pharmacy Clinical Trial Files Pharm/S39 1.0 18th July 2016
Expiry Date Extensions and Re-labelling of IMPs Pharm/S51 1.0 1st September 2016
Setting up a Clinical Trial Pharm/S45 1.0 31st July 2017

 

PHARMACY FORMS

Title Number Version number Implementation date
Certificate of Destruction Pharm/F44 3.0 27th July 2015
Code Break Record Form Pharm/F53 4.0 31st July 2017
Code Break Test Form Pharm/F50 4.0 31st July 2017
Clinical Trials Monthly Stock Check Form Pharm/F63 3.0 2nd March 2015
Distribution of Code Break Envelopes Form Pharm/F27 4.0 31st July 2017
Production of Code break Envelopes Form Pharm/F25 4.0 31st July 2017
Receipt of Code Break Envelopes Form Pharm/F26 4.0 31st July 2017
Master Label Form Pharm/F33 4.0 31st July 2017
Master Label Amendment Form Pharm/F34 3.0 31st July 2017
Stores Receipt Form Pharm/F35 4.0 28th October 2015
Temperature Monitoring Form (Fridge Temperature) Pharm/F36 4.0 19th October 2015
Clinical Trials Label Templates Pharm/F40 2.0 31st July 2017
Trial Drug Recall Summary Sheet Pharm/F41 3.0 23rd November 2015
Quarantine Notice Pharm/F42 4.0 1st July 2015
Quarantine Log Pharm/F43 4.0 1st July 2015
IMP Recall Test Form Pharm/F49 3.0 23rd November 2015
Pharmacy Clinical Trial File Contents Pharm/F52 4.0 29th May 2015
Pharmacy Monitoring Form Pharm/F97 1.0 12th April 2015
Temperature Monitoring Form (Ambient Temperature) Pharm/F54 4.0 19th October 2015
Pharmacy Training Log Pharm/F61 3.0 19th January 2016
Temperature Monitoring Form (Frozen Temperature) Pharm/F78 3.0 19th October 2015
Temperature Excursion Record Form (Clinical Trials) Pharm/F79 2.0 19th October 2015
Returning Clinical Trial Materials and Investigational Medicinal Products to the Trial Sponsor Pharm/F83 3.0 15th June 2015
Assessing an area for Investigational Medicinal Product storage outside of Pharmacy Pharm/F89 2.0 26th July 2016
Transfer of IMP from Pharmacy to a storage location outside of Pharmacy Pharm/F91 2.0 26th July 2016
Transer of unused IMP from a storage location outside of Pharmacy to Pharmacy Pharm/F92 2.0 26th July 2016
Transfer of patient returned/used IMP from a storage location outside of Pharmacy to Pharmacy Pharm/F93 3.0 26th July 2016
Protocol Amendment Receipt Record Form Pharm/F94 2.0 19th January 2016
Label Accountability Form Pharm/F104 2.0 31st July 21017
Record of Labels Printed Pharm/F105 2.0 31st July 2017
Pharmacy Clinical Trials Wardlist Check Form Pharm/F102 2.0 19th October 2015
Pharmacy Clinical Trials - Dispensing Error Reporting Log Pharm/F29 1.0 20th August 2015
Pharmacy Clinical Trials - Dispensing Error Reporting Codes Pharm/F30 1.0 20th August 2015
Daily Clinical Trials Temperature Checks Pharm/F108 1.0 19th October 2015
Record of Access to a Clinical Trial Protocol and/or Investigator Brochure Form Pharm/F111 1.0 19th October 2015
Ambient Temperature Monitoring Form for Studies Where IMP Is Stored Outside of Pharmacy Pharm/F112 1.0 19th October 2015
Pharmacy Amendment Checklist Form Pharm/F106 1.0 19th January 2016
Deviation Assessment Form Pharm/F107 1.0 23rd December 2015
Clinical Trials Prescription Audit Tracker Pharm/F103 1.0 1st March 2016
Clinical Trials Task List Form Pharm/F90 2.0 28th June 2017
Pharmacy Weekly Quality Assurance Form Pharm/F115 1.0 20th June 2016
Pharmacy Daily Quality Assurance Form Pharm/F116 1.0 20th June 2016
Pharmacy Clinical Trials Maintenance Form Pharm/F82 1.0 18th July 2016
Expiry Date Re-labelling Worksheet Pharm/F117 1.0 1st September 2016
Clinical Trial Patient Log Pharm/F38 1.0 22nd March 2017
Pharmacy Personnel Log Pharm/F39 1.0 22nd March 2017
Pharmacy Clinical Trial Set up Form Pharm/F14 1.0 31st July2017

 

PHARMACY TEMPLATES 

Title Number Version number Implementation date
Clinical Trial Prescription Template Pharm/T15 1.0 12th March 2015
Pharmacy Confirmation of Readiness Pharm/T09 4.0 1st July 2015
Template master accountability log (double blind trial) Pharm/T36 2.0 10th July 2017
Template master accountability log (open label trial) Pharm/T37 2.0 10th July 2017
Template participant specific accountability log Pharm/T38 2.0 10th July 2017
Trial Stock Management Instruction Template Pharm/T39 1.0 8th February 2016
Trial Details and Summary Template Pharm/T40 1.0 8th February 2016
Aseptics Unit Instructions Template Pharm/T41 1.0 8th February 2016
Dispensing Instructions Template Pharm/T42 1.0 8th February 2016
Accuracy and Clinical Checklist Template Pharm/T43 1.0 8th February 2016
Pharmacy Green Light Amendment Letter Template Pharm/T44 1.0 19th January 2016
Pharmacy Amber Light Amendment Letter Template Pharm/T45 1.0 19th January 2016
Pharmacy Red Light Amendment Letter Template Pharm/T46 1.0 19th January 2016
Letter Template - Study Set-Up Feasibility Pharm/T25 1.0 31st July 2017
Letter Template - Study Set-Up Review & Authorisation Pharm/T30 1.0 31st July 2017
Letter Template - Study Set-Up Pharmacy Readiness Pharm/T49 1.0 31st July 2017
Letter Template - Study Set-Up Pharmacy Green Light Pharm/F50 1.0 31st July 2017