NHS Tayside Effective Date: 24/7/2009

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2 1. PURPOSE This document describes the procedure for the supply, transport and storage of Investigational Medicinal Product (IMP). This SOP complies with the principles of Good Clinical Practice, Good Manufacturing Practice (annexe 13) and complies with the UK Medicines for Human Use (Clinical Trial) Regulations. 2. APPLICABILITY Unless otherwise specified in a clinical trial site agreement, this document applies to CTIMPs sponsored or co-sponsored by the University of Dundee, or sponsored or co-sponsored by NHS Tayside, where written confirmation of sponsorship was confirmed on or after 24 th July The site agreements for studies sponsored by organisations other than UoD or NHST but which involve NHST patients, staff or facilities should make reference to a GCP-compliant SOP. Unless otherwise specified in a clinical trial site agreement this SOP applies to all trial personnel involved in the handling or ordering of IMP(s). 3. POLICY It is the responsibility of the Sponsor, to ensure that the site is supplied with the IMP in a timely manner, although in the non-commercial setting this responsibility will generally be delegated to the CI or Clinical Trial Pharmacy Staff. The IMP must be supplied, transported and stored at sites in a manner that maintains the integrity of the product at all times until destruction. The Sponsor must ensure that documentation is provided and maintained to show that these procedures have been followed for the supply, storage and transport of all IMP. This SOP should be read in conjunction with NHS Tayside Guidelines on Drug Accountability in CTIMPs and in conjunction with other UoD IMP SOPs (see Section 5. Associated Documents). 4. PROCEDURE This SOP should be consulted by the research personnel and/or Clinical Trial Pharmacy Staff (preferably before grant submission) for each new CTIMP to ensure early consideration of all issues pertaining to the supply, storage and transport of the IMP and to ensure that the correct actions are taken. 4.1 Supply of IMP to Site At the Set-up Meeting between the CI, or delegate, and the Clinical Trials Pharmacy Staff (see NHST/UoD/TCTU/SOP38), the IMP supplier and the ordering and purchasing arrangements should be discussed. The Clinical Trial Section of Ninewells Hospital Pharmacy Department should not allow the release of the IMP until all required regulatory approvals have been obtained. See NHST/UoD/TCTU/SOP41. Page 2 of 5

3 4.2 Transport of IMP to site All IMP must be delivered to the Clinical Trial Section of Ninewells Hospital Pharmacy Department for contents and documentation check. Clinical Trials Pharmacy Staff should sign a receipt on arrival of IMP at site, and will ensure that the IMP packaging is intact and that any special storage conditions such as temperature restrictions have been maintained during transport The stability of a medicine might be affected if it is re-assembled or repackaged for use in the trial. The CI should seek advice from the manufacturer or the Clinical Trials Pharmacist if in doubt about the effect on stability of reassembling or repackaging an IMP at the trial sites The Clinical Trial Pharmacy Staff will check the IMP status, importation documents, and that labelling and all approvals are in place before release to the IMP Storage and Supply site or trial site, where applicable. A member of staff at the IMP Storage and Supply site should sign a receipt for the arrival of the IMP Shipment documents should be filed in the Pharmacy Site File (PSF), TMF and/or Investigator Site File (ISF) to confirm storage conditions during transport. In addition, all other accompanying documentation eg, quantities of IMP delivered, Qualified Person release documents, Investigator Brochure (IB) or Summary of Medicinal Product Characteristics (SmPC), should be filed in the PSF, TMF and/or ISF See NHST/UoD/TCTU/SOP37 for information on accountability of IMP in CTIMPs Items to apply to IMP transported from manufacturer to Clinical Trial Section of Ninewells Hospital Pharmacy Department, but note that when transferring IMPs to IMP Storage and Supply Sites, or between trial sites (see paragraph 4.3), it is important to ensure that optimum storage conditions with respect to temperature, humidity and exposure to light have been maintained throughout. 4.3 Transfer of IMP between investigational sites Transfer of IMP between sites should be avoided if at all possible. If it becomes necessary to transfer IMP between sites, consult Clinical Trials Pharmacy Staff and ensure that the transfer process is documented. 4.4 Storage of IMP at Site - Options for storage of IMP IMP may be stored in the Clinical Trial Section of Ninewells Hospital Pharmacy Department or in a designated IMP Storage and Supply site, as confirmed with the Clinical Trials Pharmacy Staff at the planning stage of the CTIMP. For external sites in multi-centre studies, IMP must be stored in a facility equivalent to Ninewells Hospital Pharmacy, or equivalent to an IMP Storage and Supply site. The location of IMP storage should be documented in the PSF, TMF and/or ISF. Page 3 of 5

4 4.4.2 IMP Storage and Supply Sites must be audited annually by a Clinical Trials Pharmacy Staff to ensure their suitability for purpose. If an intended IMP Storage and Supply Site has not been audited in the previous year, a pre-trial inspection must be conducted When the IMP is stored in the IMP Storage and Supply Site, the CI is responsible for the safe and secure storage of the IMP, strict record keeping, environmental monitoring and remedial action where necessary. Note, however, that IMP handling guidelines should include an account of what action is necessary in the event of evidence that temperature limits have been exceeded. If in doubt, the CI should seek advice from the Clinical Trials Pharmacy Staff on the development of site guidelines on drug storage and monitoring and appropriate recovery planning There should be a written description of the internal IMP Storage and Supply Site monitoring process included in the IMP handling guidelines and documented evidence that it has taken place Where the IMP is stored in the Clinical Trial Section of Ninewells Hospital Pharmacy Department, the Clinical Trial Pharmacy Staff assume these responsibilities and Pharmacy SOPs will be followed. 4.5 Considerations for the storage of IMPs There are important issues related to the storage and supply of medicines by Pharmacy (eg. stability, shelf life and temperature limits) that must be considered by CIs who opt to store and supply IMPs (and NIMPs) directly from IMP Storage and Supply Sites. More details are given in the NHS Tayside Guidelines on Drug Accountability in CTIMPs Unused IMPs should be stored separately from used/returned IMPs Security issues The Medicines Act 1968 sets out the requirements for the storage of medicines in pharmacies which also applies to trial drugs stored at trials sites. Secure storage of IMPs (and NIMPs) is thus part and parcel of good drug accountability practice. Important considerations in the storage of IMPs (and NIMPs) include the use of locked rooms, cupboards, fridges, etc and the personnel who have access to the site and the drugs stored therein. The following general principles apply. During working hours, the IMP Storage and Supply Site should be supervised, if not locked at all times. Out of working hours the IMP storage and Supply site should be locked at all times. Only CIs and other key members of the research team should routinely have access to IMP Storage and Supply Sites, although domestic services may Page 4 of 5

5 have access at agreed times in order to service the area. IMP should not be kept in areas through which there is unrestricted traffic. IMPs should be kept in locked facilities including boxes, cabinets and fridges, access to which should be restricted to key personnel. Note that there is a legal requirement to store Controlled Drugs (i.e. drugs covered by the Dangerous Drugs Act 1967 and Misuse of Drugs Act 1971) in a double locked facility which requires that both the storage box or cabinet or fridge and the store room be kept locked when not in use. 5. ASSOCIATED DOCUMENTS 5.1. NHS Tayside Department Guidelines on Drug Accountability in Clinical Trials of Investigational Medicinal Products 5.2. NHST/UoD/TCTU/SOP37 IMP accountability, returns and destruction 5.3. NHST/UoD/TCTU/SOP38 Manufacturing, packaging and labelling of IMP 5.4. NHST/UoD/TCTU/SOP40 Randomisation, blinding and code breaking in CTIMPs. 6. DEFINITIONS UoD TCTU NHST University of Dundee Tayside Clinical Trials Unit NHS Tayside (Tayside Health Board) 7. REFERENCES WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects. ( Medicines for Human Use (Clinical Trials) Regulations ( It is assumed that by referencing the principal regulations, all subsequent amendments made to the principal regulations are included in this citation. Good Manufacturing Practice, Volume 4 Annexe 13, Page 5 of 5