DOCUMENT TITLE: HTA_FRM004 TRACEABILITY AUDIT FORM V2.0

1.purpose

This form is used to record the findings of traceability audits (“2-way” audits) of collections registered under the University of Oxford Human Tissue Authority (HTA) Licence 12217.

2.pROCEDURE

NOTE 1: The traceability audit procedure is defined in the HTA Core SOP for Audit (HTA006)I1.

2.1The number of samples to audit will vary depending on the size of the collection, the context of audit, and whether the auditor has reason to think there may be traceability problems in the collection.

2.2As a minimum, the auditor must select 2 samples to audit from inventory to storage location, and 2 samples from storage location to inventory.

2.3For internal audits, auditors should consider selecting sufficient numbers of samples to gain insight into the level of traceability achieved across the collection (e.g. only a handful of samples for a collection storing under 100 samples, a dozen samples for a collection containing hundreds of samples, 50-100 samples for a collection containing thousands of samples, etc.).

2.4Auditors should also select samples in all storage conditions (e.g. microscope slides, FFPE blocks, frozen vials at -80C, frozen tubes in liquid nitrogen, etc.). Alternatively, if the audit is focused on a storage location which is known to be problematic, the audit may be similarly focused.

2.5The auditor will select samples at random from the inventory, tracing these to:

  1. The consent form*
  2. The storage location.

The reverse is then carried out in which two samples are selected at random from the storage location and traced back to:

  1. The consent form*
  2. The inventory system.

*If consent forms are not available for audit (for example, if specimens have been imported, the samples were collected before 1st September 2006 or consent was gained by a third party), secondary records of consent such as a copy of appropriate agreements (e.g. SLA, MTA, Collaboration Agreement) may be requested to confirm appropriate consent is in place. The Comments section of this form should be used to record such occurrences.

3.REFERENCES

I1HTA006 - Audit core SOP and HTA001 – Consent core SOP are available on iPassport:

Audit reference number
Collection name / HTGT reference number
Auditor(s)
Date of audit

Part I - Audit from Inventory to Consent Form and Storage Location- Insert more rows when needed

1. Inventory system / database / 2. Consent information / 3. Storage location / Result
Database name / Sample ID in database / Tissue type / Storage format / Storage info in database (room number, freezer number / shelf number / box number etc.) / Consent form present? Y/N / Consent form valid?
Y/N / Secondary record of consent* / research agreement / consent exemption? / Storage location (room number, freezer number / shelf number / box number etc.) / Info on sample label / Match inventory - storage location? Y/N
Sample 1
Sample 2

* Refer to HTA001 core SOP on ConsentI1 for information on secondary records of consent.

Part II - Audit from Storage Location to Inventory and Consent Form-Insert more rows when needed

  1. Storage location
/
  1. Consent information
/
  1. Inventory system / database
/ Result
Storage location (room number, freezer number / shelf number / box number etc.) / Info on sample label / Consent form present? Y/N / Consent form valid?
Y/N / Secondary record of consent* / research agreement / consent exemption? / Database name / Sample ID in database / Tissue type / Storage format / Storage info in database (room number, freezer number / shelf number / box number etc.) / Match inventory - storage location? Y/N
Sample 1
Sample 2

* Refer to HTA001 core SOP on ConsentI1 for information on secondary records of consent.