All biobank documents should be identified with the document title, author, owner, approver, date issued, version number and for paper-based systems, a Documented procedures for the copy number. creation, amendment, retention and Superseded versions of documents destruction of records should be archived and copies removed from circulation. A description of changes made should be included in revised documents. Regular of record content to check for completeness, legibility and Review of documents every 2 years at accuracy minimum, with new versions issued. Back-up/recover facility in the event of Documented back up/recovery systems loss of records made available. Systems ensure data protection, confidentiality and public disclosure (whistle-blowing) GQ5 There are documented procedures for distribution of bodies, body parts, tissues or cells. GQ6 A coding and records system facilitate traceability of bodies, body tissues and cells, ensuring a robust audit trail Minimum practice: Best practice: There is an identification system which assigns a unique code to each donation and to each of the products associated with it The audit trail contains full details of consent (i.e. specific, tiered generic consent and location of signed consent form), full details of where samples were received from and sent to. A suitable transfer agreement (e.g. MTA) is used appropriate An audit trail is maintained which Risk assessment of transportation includes details of when and where the method includes verification of bodies/body parts were put, when the maintenance of cold conditions where bodies/body parts were transferred and necessary by use of data loggers, with to whom data retained on file. GQ7 There are systems to ensure that all adverse events are investigated promptly
Documented procedures for the creation, amendment, retention and destruction of records All biobank documents should be identified with the document title, author, owner, approver, date issued, version number and for paper-based systems, a copy number. Superseded versions of documents should be archived and copies removed from circulation. A description of changes made should be included in revised documents. Regular of record content to check for completeness, legibility and accuracy Review of documents every 2 years at minimum, with new versions issued. Back-up/recover facility in the event of loss of records Documented back up/recovery systems made available. Systems ensure data protection, confidentiality and public disclosure (whistle-blowing) GQ5 There are documented procedures for distribution of bodies, body parts, tissues or cells. GQ6 A coding and records system facilitate traceability of bodies, body tissues and cells, ensuring a robust audit trail Minimum practice: Best practice: There is an identification system which assigns a unique code to each donation and to each of the products associated with it An audit trail is maintained which includes details of when and where the bodies/body parts were put, when the bodies/body parts were transferred and to whom The audit trail contains full details of consent (i.e. specific, tiered generic consent and location of signed consent form), full details of where samples were received from and sent to. A suitable transfer agreement (e.g. MTA) is used appropriate Risk assessment of transportation method includes verification of maintenance of cold conditions where necessary by use of data loggers, with data retained on file. GQ7 There are systems to ensure that all adverse events are investigated promptly