Standard Operating Procedure

Transcription

1 SOP number: Standard Operating Procedure SOP-JRO SOP full title: Consent and Sample Tracking for Samples Collected for the Newcastle Biomedicine Research Tissue Bank (REC no. 12/NE/0395) SOP effective: 16 September 2013 Review date: 16 September 2015 SOP author signature: SIGNED COPY KEPT IN THE JRO Mhairi Anderson, Quality Assurance Manager, Newcastle Biomedicine Biobank, Newcastle University SOP approval signatures: SIGNED COPY KEPT IN THE JRO Professor Andy Hall, Designated Individual, Research HTA licence (Ref ) Newcastle University SIGNED COPY KEPT IN THE JRO Susan Ridge, Research Governance Manager, The Newcastle upon Tyne Hospitals NHS Foundation Trust SOP HISTORY Version Date Reason for change 1. BACKGROUND/INTRODUCTION The Newcastle University and The Newcastle Upon Tyne Hospitals NHS Foundation Trust (NUTH FT) Standard Operating Procedures (SOPs) are designed to ensure that research, and its supporting activities, is carried out in accordance with the principles of Good Clinical Practice (GCP) and the Human Tissue Act (2004) (HTA). The HTA requires that all donated tissue held in a biobank can be tracked to an original consent form. SOP Template Version 1.1, Page 1 of 13 SOP-JRO

2 2. PURPOSE The purpose of this SOP is to provide instructions for all staff responsible for the collection and management of samples and associated clinical data into the Newcastle Biomedicine Research Tissue Bank (NBRTB) (REC no. 12/NE/0395). All staff operating under this research tissue bank must read this document before undertaking this procedure. The aim is of this SOP is to ensure compliance with the terms and conditions set out in the approval of the tissue bank, and the HTA and GCP requirements for consent and sample tracking. It should be noted that consent and sample tracking for other research tissue banks and individual studies may be managed differently and it is the responsibility of all staff to ensure that they are appropriately trained before commencing this procedure. 3. SCOPE This SOP applies to all staff responsible for the collection and management of samples into the Newcastle Biomedicine Research Tissue Bank (NBRTB) (REC no. 12/NE/0395). This includes staff working as part of the Clinical Research Directorate, as part of NUTH FT, and staff working under the remit of the Newcastle Biomedicine Biobank, as part of Newcastle University. Samples may be collected for: External researchers (i.e. commercial partners) researchers who are not employed by Newcastle University or do not hold an honorary contract with Newcastle University, or, Internal researchers researchers employed by Newcastle University, or those holding an honorary contract with Newcastle University. All staff involved in taking consent must also read Guidance for professionals taking consent for research tissue banks located on the Newcastle Joint Research Office website at the following address: 4. PROCEDURE 4.1. Application Process The application process to receive samples under the ethical approval granted to the Newcastle Biomedicine Research Tissue Bank (NBRTB) for both external and internal researchers is described below and summarised in Appendix External Researchers SOP Template Version 1.1, Page 2 of 13 SOP-JRO

3 External researchers who wish to receive samples for use in research will contact Newcastle University or NUTH FT. Researchers will be referred to the appropriate on-line application form. The external researcher will complete the on-line application form. All projects will be assigned a unique project number by the online application form, marked as EXT to highlight that the project is for External researchers (e.g. 001-EXT). On receipt of the completed on-line application form a provisional quote will be sent to the researcher by Research and Enterprise Services (RES) at Newcastle University. The request for samples will be reviewed for suitability and feasibility by the NBRTB access committee within 4-6 weeks of receipt. In parallel, RES will conduct due diligence on the external researcher to assess their suitability as a collaborator and compile a detailed costing of the proposed project. The NBRTB access committee and RES will then review the results to determine if the application has been successful. Where requests are successful, the external researcher will be contacted and the terms of the agreement negotiated by RES, including agreement on the minimum data set required for the study, where appropriate. RES will complete the appropriate Material Transfer Agreement including the agreed project details (e.g. samples, data, timeframe) as an appendix. The MTA will be sent to the external researcher for approval. This will be referred to later in the clinic as the project protocol. For unsuccessful applications the external researcher will be informed by RES Internal Researchers All requests from internal researchers to collect samples under the NBRTB should be captured using the appropriate on-line application form. All projects will be assigned a unique project number by the online application form, marked as INT to highlight that the project is for Internal researchers (e.g. 001-INT). Requests for samples will be reviewed under the terms of the research ethics approval, feasibility and scientific merit by the NBRTB access committee. SOP Template Version 1.1, Page 3 of 13 SOP-JRO

4 4.2. Study Set Up Researchers will be informed if their application has been successful by the access committee. For all approved projects under the NBRTB, a Biobank Manager will be assigned at the discretion of the Designated Individual (DI) to manage the project. The Biobank Manager (or delegate) will set up a Project Master File containing the following documents: 1. Copy of regulatory approvals including o Integrated Research Applications System (IRAS) application form o IRAS approval letter for the research tissue bank o Newcastle Biomedicine Biobank Research Protocol 2. Copy of the contract (for external researchers only) i.e. the Material Transfer Agreement (MTA) prepared by RES between Newcastle University and the client. 3. Copy of the minimum data set required for the study and any preagreed questionnaire to be completed in the clinic (where appropriate). 4. Contact details: A list of contact details including the researcher, Biobank Manager and contacts in the clinic. 5. Copy of the Service Level Agreement (SLA) covering the transfer of the samples between NUTH FT and Newcastle University and a blank copy of the Sample Transfer and Release Form under REC 12/NE/0395) see Appendix 7.1. A blank editable copy of this form can be found on the Newcastle Joint Research Office website at the following link: 6. A link to the relevant procedures that must be followed (e.g. SOPs, Guidance for Professionals Discussing Consent) Each project within the NBRTB will receive a set of sequentially numbered consent forms from the DI. The Biobank Manager (or delegate) will create a log of the consent form numbers assigned to the project, and write the NBRTB project number on each consent form. SOP Template Version 1.1, Page 4 of 13 SOP-JRO

5 Each Clinical Site involved in taking consent for the project will be assigned a batch of consent forms from this set. For each batch the consent form will be labelled with an alphabetic code after the NBRTB project number to indicate which clinic the consent form has been assigned to. The alphabetic codes to be used for each site are provided in table 1. Table 1: Codes for Clinical Sites Code R F G C W Clinical Site Royal Victoria Infirmary Freeman Hospital Centre for Ageing and Vitality (old General Hospital) Centre for Life Walker Gate e.g. Project 001-EXT with consent taken at the Freeman Hospital = 001-EXT- F Consent forms and the consent form log will be added to the Project Master File. The Biobank Manager will then send each Clinical Site involved in the project with a replica of the Project Master File (known as the Project Site File) containing the batch of original numbered consent forms assigned to that clinical site for the project. The Project Master File will be retained by the Biobank Manager. Clinical staff will then add any site specific contents to the Project Site File e.g. CVs for staff involved in the study, GCP training certificates etc Sample Collection Patients will be consented according to the procedure set out in Guidance for Professionals Taking Consent for Research Tissue Banks accessed on the Newcastle Joint Research Office website - All participants will be allocated a unique patient number comprising the project number, first and last initial and sequential 3 digit number beginning 001 (e.g. project 001-EXT, with consent taken at the Freeman Hospital, first patient John Smith = 001-EXT-F-JS This number will be added to the consent form by the clinical staff member). Three photocopies of the consent form will be taken: - The original consent form will be stored in the Project Site File. - One copy will be stored in the patient notes. SOP Template Version 1.1, Page 5 of 13 SOP-JRO

6 - One copy will be given to the patient. - One copy will be sent to the appropriate Biobank Manager at Newcastle University on transfer of the samples. All samples taken from a patient will be identified on the sample label with the unique patient number plus an alphabetical code beginning A to identify the sample number from the same patient (i.e. blood specimen 2 will be 001- EXT-F-JS-001B see figure 1). Additionally the date of collection will be added to the specimen container. 001 EXT F JS 001 B Sample number taken from that patient B=sample 2 Project number 1 for an external researcher Initials of patient e.g. John Smith Sequential 3 digit number Freeman Hospital is location of site file Figure 1: Example sample label Prior to release, the clinical team should complete section A of the Sample Transfer and Receipt Under REC 12/NE/0395 form see Appendix 7.1. Copies of this form should be made available in the Project Site File, and editable electronic copies can also be accessed via the Newcastle Joint Research Office website: Sample Transfer to Newcastle University Samples will be transferred to the Biobank Manager along with any associated data, a copy of the signed consent form and the Sample Transfer and Receipt Under REC 12/NE/0395 form with section A completed. Consent forms should be enclosed in a sealed envelope with the label: CONFIDENTIAL INFORMATION ENCLOSED SHOULD ONLY BE OPENED BY AUTHORISED INDIVIDUALS HOLDING AN APPROPRIATE CONTRACT SOP Template Version 1.1, Page 6 of 13 SOP-JRO

7 Upon receipt: Section B of the Sample Transfer and Receipt form (Appendix 7.1.) should be completed by the Biobank Manager (or delegate). The clinical staff sending the samples should be contacted to confirm that all samples and associated data have been received in good condition, and a photocopy of the completed Sample Transfer and Receipt Under REC 12/NE/0395 form sent to them for their records. The original form should be stored in the Project Master File. Where there is discrepancy in the samples received, or samples are not received in a good condition, the clinic should be contacted using the contact details provided in the Project Master File. Samples will be placed in the relevant freezer for the study and sample tracking system updated to accurately record the location of the sample (e.g. freezer number, shelf number). The signed consent form will be stored securely and sample receipt records and the sample tracking system updated to record all sample and consent information. When adding the sample details to the sample tracking database the Biobank Manager must check the patient/sample number is unique. In instances where it is believed that a patient/sample number has been duplicated, the clinic will be informed immediately and a new number assigned Sample Release Samples will be stored in an appropriate Biobank until required by the researcher (as agreed with the Biobank Manager). When it is required to transfer samples, the Biobank Manager will release the samples in line with local procedures. Samples transferred to external researchers will be transferred under the appropriate MTA. Any associated paperwork will be added to the Project Master File Sample Disposal Where it is necessary to destroy any samples this will be done in accordance with local SOPs and Newcastle Biomedicine Biobank (NBB) disposal policy, which can be found on the NBB website: End of Project At the end of the project any unused consent forms should be returned to the Biobank Manager. The Biobank Manager should contact RES to inform them that the project is complete and the Project Site File and Project Master File should be archived in accordance with local procedures. This procedure is summarised in Appendix 7.3. SOP Template Version 1.1, Page 7 of 13 SOP-JRO

8 5. REVIEW AND MONITORING OF THIS DOCUMENT This document will be reviewed every 2 years or if there is a change to the national guidance/regulations. 6. REFERENCES 6.1. The Human Tissue Act HTA Code of Practice 9 Research - research.cfm 6.3. The Newcastle Joint Research Office Website, Human Tissue Section APPENDICES 7.1. Sample Transfer and Release Form under REC 12/NE/ Application Process under the Newcastle Biomedicine Research Tissue Bank 7.3. Consent and Sample Tracking Procedure under the Newcastle Biomedicine Research Tissue Bank SOP Template Version 1.1, Page 8 of 13 SOP-JRO

9 7.1. Sample Transfer and Release Form under REC 12/NE/0395 An editable version of this form can be found on the human tissue section of the Newcastle Joint Research Office website. SOP Template Version 1.1, Page 9 of 13 SOP-JRO

10 SOP Template Version 1.1, Page 10 of 13 SOP-JRO

11 SOP Template Version 1.1, Page 11 of 13 SOP-JRO

12 7.2. Application Process under the Newcastle Biomedicine Research Tissue Bank EXTERNAL RESEARCHER (i.e. commercial partner) External researcher contacts Newcastle University or NHS Trust to request prospective sample collection for research. INTERNAL RESEARCHER (i.e. employed by Newcastle University, or holding an honorary contract) Internal researcher requests prospective sample collection for research. Researcher referred to the Newcastle University online application form Researcher referred to the Newcastle University on-line application form External researcher completes on-line application form which is assigned a unique project number including the letter EXT to indicate External The request is received by the Access Committee and RES for review RES add the application to MyProjects and identify appropriate clinician/surgeon to determine if the work is feasible and generate an indicative quote for the application (via NHS and Central Biobank) Internal researcher completes on-line application form for internal researchers which is assigned a unique project number including the letters INT to indicate Internal The request is received by the Access Committee for review Access committee inform internal researcher on the outcome of their application Provisional quote sent to external researcher for review Provisional quote agreed Provisional quote rejected by researcher & application process stopped. Application reviewed for feasibility and scientific merit by the NBRTB Access Committee RES conduct due diligence on the external researchers suitability as a commercial partner and conduct a detailed costing of the approved project Review of Access Committee & RES results to determine if the application has been successful RES inform external researcher on the outcome of their application within 4-6 weeks. Successful application Unsuccessful application - STOP Successful application MTA sent to researcher with final costing and terms and conditions in an appendix SOP Template Version 1.1, Page 12 of 13 SOP-JRO

13 7.3. Consent and Sample Tracking Procedure under the Newcastle Biomedicine Research Tissue Bank Successful application Newcastle University Newcastle Upon Tyne Hospitals NHS Foundation Trust Designated Individual (DI) assigns a Biobank Manager to the Project and provides them with a set of numbered consent forms for the study Biobank Manager sets up Project Master File and creates a log of the numbered consent forms assigned to the study Biobank Manager writes the Project number on each consent form and assigns a batch to each Clinical Site involved in the study. An alphabetic code for that site is added to the consent form after the Project number The Biobank Manager creates a copy of the Project Master File for each Clinical Site (called the Project Site File) and sends this to the Clinic along with the batch of assigned consent forms Project Site File received by each Clinical Site for the Project containing batch of consent forms assigned for that site. Site specific documents are added to the file e.g. CVs for staff, GCP certificates Patients consented by Clinical Staff according to the procedure set out in Guidance for professionals discussing consent with adult patients Patients allocated a unique patient number (comprising project number-location of project site file-first and last initial-sequential 3 digit number beginning 001) and patient number added to the consent form Three copies of the consent form taken and original form stored in Project Site File. Sample collection Sample receipt by Biobank Manager and Part B of Sample Transfer and Receipt for the NBRTB form completed and added to the Project Master File Consent form checked against sample tracking database to ensure that patient number is unique & form added to the Project Master File. Sample labelled with unique patient number and alphabetical code beginning A to identify the sample number from the same patient Part A of Sample Transfer and Receipt for the NBRTB form completed and sample sent to Biobank Manager with any pre-agreed data, a copy of the consent form in a sealed, labelled envelope Where appropriate, samples added to appropriate freezer and sample tracking system updated with storage location and sample details Samples released to researchers according to local sample release procedures End of project. Unused consent forms requested from clinic, and Project Master File archived Unused consent forms returned to the Biobank Manager and Project Site File archived. SOP Template Version 1.1, Page 13 of 13 SOP-JRO