Details: Author: Neville Young Quality Assurance Manager SOP Pages: Version No. of replaced SOP: Effective date of replaced SOP: NA NA Approval: Version No: of the SOP being approved. Name of person approving this SOP. Date Signature of the person approving this SOP. 1.0 Dr Derek Norfolk Associate Director of R&D Leeds Teaching Hospitals NHS Trust 1.0 Clare Skinner Faculty Head of Research Support University of Leeds Distribution & Storage: Distribution to All Research Staff conducting or assisting with a CTIMP trial within Leeds Teaching Hospital NHS Trust Location of Document Paper: Electronic: Quality Assurance, Research and Development, Leeds General Infirmary I:\QA\1_SPONSOR_LEEDS_DOCUMENTS\SOPs/ R&D website Page 1 of 7
CONTENTS Contents Page 2 Section A - Introduction Page 3 Section B - Applicability Page 3 Section C - Glossary Pages 3-4 Section D A Researchers Guide to Sample Collection and Management Pages 4-8 1 Planning your Sample Collection Pages 4 2 Sample Collection Page 4 3 Sample Transport Pages 4 4 Sample Receipt & Storage Pages 4 5 Processing Page 6 6 - Equipment Maintenance Page 6 7 Temperature Records Page 6 8 Reagents Page 6 9 Data Handling Page6 10 Contracts Page 6 11 Quality Assurance & Quality Control Page 6-7 Section E - References Page 8 Section F - Definitions Page 9 Page 2 of 7
Please note: This SOP should be used and followed in conjunction with other LTHT SOPs developed for researchers to support study set up and management. These can be found on the LTHT website or by contacting R&I directly..?????. For clinical trials where Leeds is not the trial Sponsor you may use these SOPs as guidance, but refer to any Sponsor SOPs for further information. Section A Introduction 1.1 This Standard Operating Procedure (SOP) acts as a guide for all researchers, to aid with the collection and management of Samples for analysis when conducting a Clinical Trial of an Investigational Medicinal Product (CTIMP) within Leeds Teaching Hospitals Trust (LTHT) and the University of Leeds (UoL). 1.2 The collection and management of is essential for evaluation and validation of clinical findings, observations, and other activities during a clinical trial. Documentation and use of systems to collect and manage will substantiate the integrity of the trial data results. This SOP serves to ensure quality by requesting that all are collected, stored and analysed in a demonstrable manner such that high quality data generated can be confirmed by audit and inspection 1.3 This SOP will provide specific support to the protocol on how to collect & process consistently and how equipment and processes with Labs should be maintained to ensure high quality outcomes. This SOP is applicable to all CTIMPs sponsored by LTHT or UoL. At the end of the SOP you will also find general advice, tips and rules. Section B Applicability 1.1 This SOP is applicable to all CTIMPs being conducted within LTHT / UoL. 1.2 All members of research staff involved in running CTIMPs who collect process or analyse trials including, but not restricted to: Chief and Principal Investigators, Research Nurses and laboratory staff. 1.3 The Investigator has ultimate responsibility for ensuring that all applicable study site staff adheres to this SOP. Section C Glossary Audit Trail A trial Sample Confidentiality Documentation that allows reconstruction of the course of events Any sample of tissue (saliva, blood, plasma, urine etc) collected from a participant in a clinical trial for analysis within that trial. Prevention of disclosure, to other than authorised individuals, of a sponsor s proprietary information or of a subjects Page 3 of 7
Source Data Source Documents identity All information in original records and certificated copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained within source documents. Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files and records kept at pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial. Section D A researchers guide to Sample Collection & Management 1.0 Planning your Sample Collection When setting up where trial are to be collected and analysed it is important to consider the following; 1.1 Sample Type - collected within a CTIMP fall into two categories; 1.1.1 Samples collected for Routine (standard care) analysis. 1.1.2 Samples collected for specific trial related analysis which may occur in a 3rd party laboratory All relevant information regarding sample type, collection, analysis and storage can be located in the protocol. 1.2 Storage If the are to be stored for any length of time then you should consider where they will be stored, how they will be transported, and storage conditions (for transport and at destination). 1.3 Analysis do you have assurance that the analysis will be accurate, equipment should be serviced and calibrated, software should be up to date and validated, SOPs should be in place to described how equipment and software is used. 1.4 Contracts where are being transported to a 3 rd party laboratory not managed by the sponsor or site of collection, a contract should be in place between Page 4 of 7
the sponsor and the 3 rd part laboratory. This contract should describe mutually agreed quality standards for the handling and management of the. 1.5 Training It is important that all lab personnel have received the appropriate training for the task they will be undertaking and that this training is recorded. Please note if monitored/audited/inspected ALL relevant information regarding the sample life history must be provided including records of how it was transported and where it was stored in order to ensure a full audit trail of each sample can be produced. 2.0 Sample Collection Individuals collecting or receiving as part of a CTIMP should have appropriate assurance in place to confirm that study has been approved by the host organisation, and that consent has been taken from the patient prior to any trial procedure taking place. This included screening and baseline tests.. Samples should be collected as described in the protocol, collection vessels may be supplied Samples may undergo preliminary manipulation at site eg centrifugation, refrigeration if so local equipment used should have appropriate servicing and calibration records available for review. 3.0 Sample Transport If are collected for routine standard care analysis they should be processed and transported to local laboratories in line with local standards procedures. Trial may have a different coloured request forms to identify them as trial specific. Samples being transported to a 3 rd party location must be collected, packaged and transported as described in the protocol. If the protocol is unclear then reference should be made to the contractual agreement between the sponsor and the 3 rd party laboratory to establish the mode of transport. If uncertainly remains please contact the sponsor directly. If a courier is needed to transport please retain evidence of transport including collection and delivery sign off. Temperature specific couriered should use a tag system to supply evidence that have not exceeded the agreed temperature during transit. 4.0 Sample receipt and Storage 3 rd party laboratories receiving should have robust systems in place to receive and process in a timely and efficient manner. For instance an electronic database to catalogue, laboratory staff should have access to appropriate labels for an expected number of. Research teams should seek assurance through the contract with the laboratory that these processes meet the needs of the type of sample collected and transport to the laboratory. Page 5 of 7
5.0 Processing Documented systems and processes, often in the form of SOPs should be in situ at the laboratories detailing how are processed and how equipment used to support this activity. 6.0 Equipment Maintenance Equipment in 3 rd party laboratories, including computers and software, should be serviced, maintained and validated in accordance with, as a minimum standard, the manufactures recommendations. Clear records of servicing and calibration checks should be available. For instance are volumetric devises calibrated before servicing to confirm accuracy over the intervening period since a previous service? 7.0 Temperature Records Where trial are stored in fridges and freezers an appropriate log of regular temperature reading should be maintained to provide assurance on the quality of storage conditions of clinical trial AND reagents (antibodies) used to analyse them. Where appropriate, suitable alarms and back up systems should be in place to mitigate against equipment or power failures. Any temperature variations or failures should be recorded and managed according to the local laboratory SOPs. 8.0 Reagents. Reagents used in laboratories in the analysis of clinical trial should be subject to a robust Quality Control process to ensure that they are received into the laboratories in a state fit for purpose and are stored and used appropriately. These QC processes should be documented. 9.0 Data Handling 3 rd Party laboratories producing data for clinical trial must have systems and processes in place to ensure data is recorded and transferred accurately. That appropriate QC is undertaken on the data. Data produced in laboratories may be termed source data and appropriate steps must be taken to ensure that this data is stored appropriately for the duration of the trial. All sample related data should be appropriately anonymised so as not to breach patient confidentiality. 10.0 Contracts Contracts with 3 rd party labs should describe the standards the laboratory will be working to. They do not need to detail all written procedures but should reference the standards at which the laboratory expects to work. Please discuss these agreements with the QA team early in the approval process. If you are working with academic partners in the University you may still need a contract to be in place this may only be to describe the standards agreed. 11.0 Quality Assurance and Quality Control Page 6 of 7
The laboratory may have accreditation (which should be up to date and available for review) describing the QA and QC processes within the laboratory. These should work independently but with direct reference to each other. The accuracy of all lab processes should be subject to a proportionate level of QC. The QA process is different and should address whether the labs quality systems are operating effectively. If the QA systems are operating effectively they will minimise the possibility of QC uncovering any discrepancies, but where they are identified should aid rapid identification of problems and support solutions. Quality Management systems should be present in any laboratory managing clinical trial to provide a level of assurance for the sponsor. Section E References MHRA Good Clinical Practise Guide 2012 Chapter 13 E6 Guideline for Good Clinical Practise version 2.1 August 2011 Section F CTIMP GCP LTHT MHRA QA R&D REC SOP QA QC Definitions Clinical Trial of an Investigational Medicinal Product Good Clinical Practise Leeds Teaching Hospitals Trust Medicines and Healthcare products Regulatory Agency Quality Assurance Research and Development Research Ethics Committee Standard Operation Procedure Quality Assurance Quality Control Page 7 of 7