ECTU Central Office SOP ECTU_TM_17 Management of Trial (IMP) Supplies

Transcription

1 ECTU Central Office SOP ECTU_TM_17 Management of Trial (IMP) Supplies SOP number: ECTU TM 17 Signature Date Authored by: Holly Ennis, Trial Manager 6 th Sept 2017 Reviewed by: Laura Forsyth, Trial Manager 7 th Sept 2017 Reviewed By: Chris Tuck, Trial Manager 7 th Sept 2017 Approved By: Gina Cranswick, Trial Team Leader 13 th Sept 2017 Page 1 of 5

2 1. PURPOSE ECTU SOP number: ECTU TM 17 Trial supplies are defined as the supplies provided to the investigator to conduct the trial and include drugs, devices, metres, laboratory kits and other special equipment. The provision of trial supplies is highly regulated and it is important to ensure compliance with ICH-GCP requirements. Trial supplies should be considered during the protocol development phase and sufficient resources requested to cover their costs. The purpose of this SOP is to describe the procedure for assessing the status of drug trial supplies within studies adopted into ECTU and where responsibility for this has been delegated to ECTU. It also sets out the processes that must be in place to document the receipt, management, use, accountability and return of drug supplies within ECTU adopted studies. The management of other trial supplies (i.e. devices, laboratory kits, equipment etc.) are detailed within study-specific working practice documents or SOPs where required 2. SCOPE This SOP should be used for all studies adopted into ECTU that require trial drug supplies and where this task has been delegated to ECTU. In the event that a Sponsor SOP overrules an ECTU SOP then the Sponsor SOP will be applied. 3. PROCEDURE 3.1 Early assessment of status of trial drug supplies The status of the trial drug supplies should be established as early as possible in the trial planning process to determine: - Regulatory considerations (i.e. Investigational Medicinal Product (IMP), Non- Investigational Medicinal Product (NIMP), eligible for reduced requirements from MRC/DH/MHRA Joint Project on risk-adapted management of clinical trials of IMPs). A decision on whether a trial involves an IMP or NIMP should be made according to the MHRA algorithm Is it a clinical trial of a medicinal product? in conjunction with the CI and Sponsor. - Product considerations (i.e. existing commercial product with marketing authorisation in an EU state) - GMP manufacture considerations - Standards, specifications and manufacturing scope - Costings The Trial Supplies Checklist contained within the Clinical Trials Toolkit on Trial Supplies represents a detailed list of the considerations to be taken into account ( Guide.pdf) Identification of manufacturers of trial drug supplies All sites manufacturing an IMP into its final dosage form as well as any packaging, labelling and assembly for clinical trial use must hold Manufacturers Authorisation for Page 2 of 5

3 Investigational Medicinal Products (MIA(IMP)) and all IMP must be Qualified Person (QP) released for clinical trial use on behalf of the Sponsor. A technical agreement is the basic requirement for ensuring compliance regarding Manufacturing Authorisation, Marketing Authorisation and the responsibilities of the Sponsor and the manufacturer of the IMP. ECTU should work closely with the Sponsor contract team to ensure that any technical agreement clearly documents product sourcing, QP responsibilities, recall procedures, approval and supply of documentation, testing and retention schedules and temperature monitoring Development of trial supply management systems An appropriate drug supply management system should be in place. If this is incorporated within a bespoke data collection system developed by ECTU then IT SOPs 1-12 will be followed to ensure that procedures are robust and fully auditable. Labelling Labelling should be developed in conjunction with the manufacturer and Sponsor at the start of the study. Labelling should be generated in accordance with Annex 13 requirements (unless approval for reduced labelling is in place), submitted, and approved by the MHRA prior to study commencement. Labelling may be different if the trial is taking place outside the EEA. Depending on the trial, the label template may be provided by the drug company or generated by ECTU in conjunction with the Sponsor. Please see Supplies-Guide.pdf for more detail Shipment of trial drug supplies According to the delegation of responsibilities set out in the University of Edinburgh s standard site agreement and co-sponsorship agreement templates, it is the Sponsor s responsibility to ensure that IMP is supplied, packaged, labelled and released in accordance with the regulations. A manufacturer or distribution company, according to the technical agreement, will carry out shipments of trial supplies to site on behalf the Sponsor. Contracts for drug delivery are usually between the manufacturer and the distribution company or the Sponsor and the distribution company. Shipping of trial drug supplies will be conducted by the drug manufacturer or by a distribution company at the request of ECTU once all relevant regulatory approvals are in place. IMPs should remain under the control of the manufacturer until after completion of a two-step release procedure: certification by the QP and release following fulfilment of the requirements of Article 9 (Commencement of a clinical trial) of Directive 2001/20/EC. Both releases should be recorded and retained in the relevant trial files held by or on behalf of the Sponsor. Decoding arrangements should be made available to the appropriate responsible personnel before IMPs are shipped to sites, typically by the drug manufacturer or distribution company. A detailed record of shipments made by the manufacturer or importer should be maintained. It should particularly mention to whom the shipment is addressed and delivered Receipt of trial supplies Page 3 of 5

4 Where the drug manufacturer contracts a distribution company to ship IMP to sites, a drug supply agreement will detail the checks that should be made on receipt of the IMP. The shipment form is then sent to the distribution company. Checks would would be carried out by site pharmacy staff and would typically include: Ensuring supplies are correctly addressed Ensuring all packaging intact Ensuring that the quantity, batch/serial numbers, correspond with shipment form 3.6. Patient use of trial supplies The investigator or designee should explain the correct use and storage of the trial supplies to each participant at the start of the trial and should check, at intervals appropriate to the trial, that each participant is following the instructions properly. The participants should be instructed to return all unused supplies including empty containers at each visit (or as detailed within the current trial protocol). The supplies should be reconciled against the supplies dispensed to the participant and the supplies used by the participant, according to the trial requirements. Any discrepancies must be accounted for and commented upon Return or destruction of trial supplies At the end of the trial overall reconciliation of supplies must take place. Any discrepancies should be reported to the Sponsor. Trial supplies should be returned on agreed conditions defined by the Sponsor, specified in approved written procedures. Returned supplies should be clearly identified and stored in an appropriately controlled, dedicated area. Inventory records of the returned supplies should be kept. If supplies are to be destroyed then records must be made including the date of destruction and the personnel responsible. Recalls Procedures for retrieving trial supplies and documenting this retrieval should be agreed by the sponsor, in collaboration with the manufacturer or importer where different. The investigator needs to understand their obligations under the retrieval procedure. The Sponsor should ensure that the supplier of any comparator or other medication to be used in a trial has a system for communicating to the trial team the need to recall any product supplied Re-allocation of trial supplies Trial supplies must not be re-allocated or transferred to another site unless in exceptional circumstances. This should only occur following discussion and agreement with the Sponsor, drug manufacturer, and in accordance with a studyspecific SOP. All documentation concerning re-allocation of supplies must be retained in the site file, including evidence of any shipment receipts and temperature monitoring Storage of trial supplies ECTU must ensure as part of the site feasibility and set-up process that supplies can be stored at sites under appropriate conditions as specified by the study SPC and/or IB. Advice will be sought form Clinical Trial Pharmacist and/or Sponsor. Pharmacies must have facilities that allow for trial supplies to be stored separately Page 4 of 5

5 from normal pharmacy stock in areas with restricted access. The instructions of storage should be provided with all trial supplies. This should include any information about the temperature range or light conditions. It is the responsibility of the site investigator to ensure that the supplies are managed and used correctly at their site. If there is a temperature requirement the trial supplies should be monitored to ensure that storage conditions meet these requirements and a temperature log should be maintained. If the supplies need to be kept in a refrigerator there should be a temperature-recording device to monitor changes in temperature and it should ideally be alarmed. Evidence of regular maintenance and recalibration of temperature monitoring equipment should be available on request Randomisation procedures and unblinding Procedures should describe the generation, security, distribution, handling and retention of any randomisation or identification code used for packaging trial supplies and code-break mechanisms. Appropriate records should be maintained. The randomisation procedures as specified in the trial protocol should be followed at all times. Unblinding procedures are detailed in the protocol and will vary across trials. The participant s welfare must always take priority over any other consideration in determining when a code break should be revealed. Except in the case of an emergency, the code-break should only be revealed with the agreement of the Sponsor Incident reporting Incidents that occur as part of the trial should be documented as protocol deviations and/or protocol violations and submitted to ACCORD. 4. RELEVANT DOCUMENTS Clinical Trials Toolkit on Trial Supplies ( 5. DOCUMENT HISTORY Version Number: Effective Date: th Sept 2017 Reason(s) for change(s): New document Page 5 of 5