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A coding and records system facilitates the traceability of bodies and human tissue, ensuring a robust audit trail

 HTA standard                                

 Examples of best standard practice

 a)   There is an identification system which assigns a unique code to each donation and to each of the products associated with it.

  • Each sample and derivative should have a local SOP explaining how they will be labelled uniquely.

 b)  A register of donated material, and the associated products where relevant, is maintained

  • This can be in the form of an excel sheet or via SGUL ItemTracker

c)  An audit trail is maintained, which includes details of: when and where the bodies or tissue were acquired and received; the consent obtained; all sample storage locations; the uses to which any material was put; when and where the material was transferred, and to whom.

  • Include dates and reasons for disposal, partial disposal, or use of sample.

d)  A system is in place to ensure that traceability of relevant material is maintained during transport.

  • Local SOPs should be developed where relevant material is transported.

  • SOPs should detail the local arrangements for traceability of samples throughout the transfer process.

  • Specialist couriers should be used wherever possible.

  • Service Level agreement in place with courier companies.

  • Relevant material must be subject to a chain of custody process.

e)  Records of transportation and delivery are kept.

  • Records should detail individual samples of relevant material.

  • Transportation documents retained.

f)  Records of any agreements with courier or transport companies are kept. 

  • Agreements should be reviewed regularly.

  • Copies should be retained in HTA files.

g)  Records of any agreements with recipients of relevant material are kept.

  •  Responsibilities of provider and recipient parties should be set out in a MTA or as part of a service level agreement.

  • Agreements must be go through the JRES for signing.

  • Agreements stored centrally and accessible for internal audit/HTA inspection.

  • Copies of signed MTA should be retained in the researcher’s HTA site files.

 

 

 

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