York Foundation Trust R&D Unit

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	4.0	21st December 2017
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	2.0	21st December 2017
Destruction of Investigational Medicinal Product	Pharm/S57	4.0	19th December 2017
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 Clinical Trials List	Pharm/S61	5.0	18th October 2017
Managing Code Break Procedures	Pharm/S54	4.0	19th December 2017
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	3.0	19th December 2017
Quarantine of IMP	Pharm/S59	4.0	1st July 2015
Receipt and Review of Amendments in Pharmacy	Pharm/S79	3.0	24th May 2018
Receiving Clinical Trials Materials and Investigational Medicinal Products into Pharmacy Stores	Pharm/S46	6.0	18th June 2018
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 Non-Investigational Medicinal Products for clinical trials	Pharm/S33	2.0	13th December 2017
Stock Management of IMP in Pharmacy	Pharm/S70	5.0	19th December 2017
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	7.0	5th February 2018
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	2.0	21st December 2017
Recording and monitoring of dispensing errors in clinical trials	Pharm/S87	2.0	21st December 2017
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 trials protocols and investigator brochures in pharmacy	Pharm/S106	2.0	28th February 2018
Documenting, managing and reporting deviations	Pharm/S104	1.0	23rd December 2015
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	4.0	19th December 2017
Code Break Test Form	Pharm/F50	4.0	31st July 2017
Clinical Trials Monthly Stock Check Form	Pharm/F63	5.0	19th December 2017
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	5.0	18th June 2018
Clinical Trials Label Templates	Pharm/F40	2.0	31st July 2017
Trial Drug Recall Summary Sheet	Pharm/F41	4.0	21st December 2017
Quarantine Notice	Pharm/F42	5.0	18th June 2018
Quarantine Log	Pharm/F43	5.0	18th June 2018
IMP Recall Test Form	Pharm/F49	4.0	21st December 2017
Pharmacy Clinical Trials File Contents	Pharm/F52	5.0	18th June 2018
Pharmacy Monitoring Form	Pharm/F97	1.0	12th April 2015
Pharmacy Training Record	Pharm/F61	4.0	18th June 2018
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
Receipt and Review of Amendments in Pharmacy Form	Pharm/F94	3.0	24th May 2018
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	21st December 2017
Pharmacy Clinical Trials - Dispensing Errors Reporting Log and Codes	Pharm/F29	2.0	21st December 2017
Daily Clinical Trials Temperature Checks	Pharm/F108	2.0	5th February 2018
Record of access to a clinical trial protocol and/or investigator brochure	Pharm/F111	2.0	28th February 2018
Deviation Assessment Form	Pharm/F107	1.0	23rd December 2015
Clinical Trials Task List Form	Pharm/F90	2.0	28th June 2017
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
Pharmacy Invoice Template	Pharm/F14	4.0	18th June 2018
Clinical Trial Prescription Template	Pharm/T15	2.0	21st December 2017
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
Dispensing Instructions Template	Pharm/T42	1.0	8th February 2016
Accuracy and Clinical Checklist Template	Pharm/T43	1.0	8th February 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/T50	1.0	31st July 2017