Standards, Harmonisation and Audit. Anne Carter

Transcription

1 Standards, Harmonisation and Audit Anne Carter

2 Outline of the presentation UKCRC Funders Vision for Human Tissue Resources The call and our response The harmonisation environment Self-assessment and peer review Biospecimen science What next for harmonisation?

3 UKCRC Funders Vision for Human Tissue Resources Improving the characterisation of tissue resources to understand their quality 12. There is no absolute standard for sample quality; the requirements in each case will depend on the intended use of the tissue. Nor is there a single, best method for sample collection or storage. [ ] A range of good practice guidance already exists and so it is possible for funders to require proposed collections to show evidence that their protocols will comply with good practice in key areas. [ ] Action 4: Funders will consider and implement practical ways by which their boards and committees can evaluate how well a proposed tissue collection will comply with existing good practice in the collection and storage of samples.

4 UKCRC Funders Vision for Human Tissue Resources Improving the characterisation of tissue resources to understand their quality 14. Funders will consider other mechanisms for assessing compliance with good practice. For example, meeting the criteria for accreditation under schemes such as the one under discussion by the NCRI s Confederation of Cancer Biobanks. It is recognised that this would not be necessary or suitable for all, awardees will need to consider other schemes or guidance to determine the most appropriate. Action 5: Funders will work towards a common set of good practice requirements and associated mechanisms for assessing compliance.

5 The call Provide coordination and guidance to increase harmonisation of standards across the entire biosample lifecycle. This should take account of existing guidance on standardisation and provide coordination as opposed to duplication of activity. The Centre should focus on aligning guidance, highlighting best practice to collections of human sample and identifying areas where standards are required Making funders aware of any lack of alignment between the various sources of guidance.

6 Harmonisation work stream D5: Standards developed and agreed Through stakeholder engagement In light of development of ISO standards Include requirements and best practice D6: Biobank self-assessment scheme available D7: Peer-review based audit scheme available D8: Review of biospecimen science reported Whenever possible, gold standard procedures identified Matrix of sample quality vs intended use developed D9: Biobanking toolkit available

7 Work plan Evaluation of current standards and guidelines There are lots!

8 Guidelines/best practice/standards OECD - Best Practices Guidelines for Biological Resource Centres IARC/WHO - Common Minimum Technical Standards and Protocols for Biological Resources Centres Dedicated to Cancer Research ISBER - Best Practices for Repositories I: Collection, Storage and Retrieval of Human Biological Materials for Research Australasian Biospecimen Network Biorepository Protocols Brazilian guidelines for biorepositories and biobanks of human biological material Korea - Best Practice Guidelines for research resource centers USA - National Cancer Institute - Best Practices for Biospecimen Resources

9 ISO standards ISO 9001:2008 Quality Management Systems - Requirements NF S96-900: Quality of Biological Resource Centres (BRC s) Management System of a BRC and Quality of Biological Resources ISO 17043: Conformity Assessment General requirements for proficiency testing ISO 17025: General requirements for the competence of testing and calibration laboratories ISO 15189: Medical laboratories Particular requirements for quality and competence ISO Guide 34: General requirements for the competence of reference material producers ISO 27001: Information Security Management Systems

10 ISO TC Biotechnology WG 1 WG2 WG3 WG4 Terms and Definitions Biobanks and bioresources Analytical methods Bioprocessing WG5 WG6 Data processing including annotation, analysis, validation, comparability and integration Metrology

11 SPIDIA and CEN Dr Uwe Oelmuller, Joint Meeting of BBMRI.at and BBMRI-ERIC National Nodes, Obergurgl, March 13th 2015,

12 CCB delivered:

13 STRATUM delivered:

14 Guidelines/Standards/Support MRC s Regulatory Support Centre HTA Human tissue legislation summaries Data and tissues toolkit MRC Ethics Series: Human Tissue and Biological Samples for use in Research Human tissue e-learning Guidance for professionals NRES Ethical review of research tissue banks

15 Work plan Evaluation of current standards and guidelines Biobank self-assessment scheme Online and paper based

16 Work plan Evaluation of current standards and guidelines Biobank self-assessment scheme Biobank audit scheme Review of CCB pilot with participants

17 CCB audit scheme Pilot scheme implemented Audited against the requirements of the CCB standards Aim: To improve the standards and the audit scheme To allow biobanks to see how compliant they are in a nonthreatening environment Outcomes: Six pilot audits performed Cancer and non-cancer biobanks Hospital, academic and pharma biobanks audited System improved!

18 Work plan Evaluation of current standards and guidelines Biobank self-assessment scheme Biobank audit scheme Review of CCB pilot with participants Stakeholder consultation Take note of: HTA licensing Human tissue banks accreditation in Scotland Existing biobank certifications (ISO 9001, ISO 27001) Ethical approval scheme for Research Tissue Banks Auditor training Sustainability plan

19 Work plan Evaluation of current standards and guidelines Biobank self-assessment scheme Biobank audit scheme Review of biospecimen science Current initiatives identified Gaps and priorities identified

20 Biospecimen science NCI - BBRB IBBL ISBER Biospecimen Science WG BBMRI-ERIC Molecular Medicine Ireland UK Biobank NCRI Clinical Studies Groups..

21 What next for harmonisation? Develop Management and Evaluation Groups Seek input to plans Align work with BBMRI-ERIC Get started!

22 Contact me: Anne Carter UKCRC Tissue Directory and Coordination Centre Farr Institute 222 Euston Rd London NW1 2DA Tel: Website: