Standard Operating Procedures (SOPs) Research and Development Office
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1 Standard Operating Procedures (SOPs) Research and Development Office Title of SOP: Investigational Medicinal Products (IMPs) SOP Number: 18 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August 2015 Author: Approved by: Alison Murphy, Research Manager Endorsed by Paul Carlin Dr David Hill Signed: Date: 01 August 2013
2 Version History: Version No. Date Author Reason for Change 1.0 Sept 2007 Katrina Hughes N/A 2.0 Aug 2011 Alison Murphy Updated to new SOP format Document Number: SOP/RPH/SEHSCT/018 Page 2 of 5
3 Table of contents 1. Introduction 2. Objective 3. Scope 4. Policy 5. Regulations, Guidelines, references, SOP Links etc 6. Appendices Document Number: SOP/RPH/SEHSCT/018 Page 3 of 5
4 1. INTRODUCTION An Investigational Medicinal Product (IMP) is the pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. Commercial and non-commercial interventional clinical trials involving the administration of IMPs to human subjects are regulated by the provisions of the Medicines for Human Use (Clinical Trials) Regulations (as amended 2,3 ). Practice guidance regarding the management of IMPs has been prepared as part of the Department of Health / Medical Research Council Joint Project 4 to codify good practice in publicly funded clinical trials, and by the Institute of Clinical Research and the Royal Pharmaceutical Society of Great Britain 5 (jointly). This is supplementary to the overarching Acts, regulations and guidelines for the safe and secure handling of medicines in hospitals provided by the Medicines Act 6, The Misuse of Drugs Act 7, the Duthie Report 8 / Use and Control of Medicines 9 and the NHS Controls Assurance Standards on Medicines Management (Safe and Secure Handling) OBJECTIVE The objective of this SOP is to ensure that the use of IMPs within the Trust is controlled by procedures that safeguard trial subjects, healthcare professionals and the Trust and which comply with all regulatory and good practice requirements. This Policy addresses the management of Investigational Medicinal Products (IMPs) in South Eastern Health and Social Care Trust. 3. SCOPE This SOP applies to all clinical trials of investigational medicinal products (CTIMPs) being conducted in the South Eastern Trust. 4. POLICY It is the policy of this Trust that all IMPs to be used in clinical trials regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) are, in accordance with DHSSPS guidelines 9, managed by the relevant Trust Pharmacy. The Trust Pharmacy will have in place appropriate Standard Operating Procedures (SOPs) to ensure that IMPs are managed in compliance with the relevant regulations, national guidelines and Trust research governance procedures. Document Number: SOP/RPH/SEHSCT/018 Page 4 of 5
5 5. REGULATIONS, GUIDELINES, REFERENCES, SOP LINKS etc. 1. The Medicines for Human Use (Clinical Trials) Regulations 2004 (Statutory Instrument No. 1031). Crown Copyright. 2. The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (Statutory Instrument No. 1928). Crown Copyright. 3. The Medicines for Human Use (Clinical Trials) Amendment (No. 2) Regulations 2006 (Statutory Instrument No. 2984). Crown Copyright. 4. Management Issues for Clinical Trials of Medicines in NHS Hospitals with Particular Reference to the Pharmacy. Medical Research Council / Department of Health. 5. Practice Guidance on Pharmacy Services for Clinical Trials. Institute of Clinical Research / Royal Pharmaceutical Society of Great Britain. June The Medicines Act Crown Copyright. 7. The Misuse of Drugs Act Crown Copyright. 8. The Safe and Secure Handling of Medicines: A Team Approach. Royal Pharmaceutical Society of Great Britain. March Use and Control of Medicines. Guidelines for the safe prescribing, administration, handling, storage and custody of medicinal products in the Health and Personal Social Services. Department of Health, Social Services and Public Safety. April Medicines Management Standard (Safe and Secure Handling of Medicines). April Crown Copyright. 6. APPENDICES None Document Number: SOP/RPH/SEHSCT/018 Page 5 of 5
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