ensure uniformity between staff in the performance of a specific function and should be followed to the letter by all staff who have been appropriately trained. People undertaking the processes should be involved in developing the SOPs to ensure that the written procedures reflect actual practices. Regular review of SOPs will help to prevent incremental departure from written processes with passing time and allow establishments to identify improvements. Establishments should introduce a system to record that staff have read and understood SOPs. If human tissue is to be transferred between establishments, consideration must be given to minimise the likelihood of theft, damage or loss during transport. Some form of formal transfer arrangement, for example, as part of a Material Transfer Agreement (MTA) should define how the human tissue is preserved, any potential contamination risks associated with it; and who is responsible for disposal, if applicable. We do not specify or endorse any particular format for MTAs; a number of template agreements are publically available and can be adapted to suit individual circumstances. Transportation procedures should also give sufficient detail to ensure the integrity of the tissue. There is a document control system. Guidance Governance documents should include: Revision history and version number ‘Effective from’ date Review date (at least every three years) Pagination Author and reviewer names There are change control mechanisms for the implementation of new operational procedures. Guidance Change control mechanisms should take into account the risks of any planned changes, any validation required, any training required and how implemented changes will be reviewed. Matters relating to HTA-licensed activities are discussed at regular governance meetings, involving establishment staff. Guidance
ensure uniformity between staff in the performance of a specific function and should be followed to the letter by all staff who have been appropriately trained. People undertaking the processes should be involved in developing the SOPs to ensure that the written procedures reflect actual practices. Regular review of SOPs will help to prevent incremental departure from written processes with passing time and allow establishments to identify improvements. Establishments should introduce a system to record that staff have read and understood SOPs. If human tissue is to be transferred between establishments, consideration must be given to minimise the likelihood of theft, damage or loss during transport. Some form of formal transfer arrangement, for example, as part of a Material Transfer Agreement (MTA) should define how the human tissue is preserved, any potential contamination risks associated with it; and who is responsible for disposal, if applicable. We do not specify or endorse any particular format for MTAs; a number of template agreements are publically available and can be adapted to suit individual circumstances. Transportation procedures should also give sufficient detail to ensure the integrity of the tissue. There is a document control system. Guidance Governance documents should include: Revision history and version number ‘Effective from’ date Review date (at least every three years) Pagination Author and reviewer names There are change control mechanisms for the implementation of new operational procedures. Guidance Change control mechanisms should take into account the risks of any planned changes, any validation required, any training required and how implemented changes will be reviewed. Matters relating to HTA-licensed activities are discussed at regular governance meetings, involving establishment staff. Guidance
HTA%20Consultation%20-%20Standards%20-%20Research%20sector.docx