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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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