TABLE 8

Recommended Clinical Data Set to Accompany Solid Tissue

Clinical DataBiopsy/SurgicalPostmortemOrgan or Tissue DonorOtherwise Discarded
Ethics approval no.YesYesYesYes
Consent/assent on fileYesYesYesYes
Authorization document for tissue transfer/disclosure of Information Form on fileYesYesYesYes
Underlying disorderYesYesYesYes
Stage of disease/treatment statusaYesYesYesbYes
AgeYesYesYesYes
GenderYesYesYesYes
EthnicityYesYesYesYes
Active infectioncYesYesYesYes
Weight, height, and BMIdYesYesYesYes
Medical historyYesYesYesYes
ComorbiditiesYesYesYesYes
MedicationsYesYesYesYes
Cause of deathNAYesYesNA
Agonal stage/survival timeNAYesYesNA
Autopsy findings detailseNAYesYesYes
Family historyfYesYesYesYes
Age of mother/gestational age of fetusNAYesYesYes
Access to other tissues from same patientNAYesYesYes
Access to patient-matched healthy control tissue/or patient-matched nonmalignant tissueYesYesYesYes
Reason for not suitable for transplantationNAYesYesYes
Isolation siteYesYesYesYes
PMINAYesYesgNA
Processing protocolYesYesYesYes
Storage protocolYesYesYesYes
Shipping system availableYesYesYesYes
Storage timehYesYesYesYes
Tissue integrity markeriNAYesYesbNA
Freeze/thaw stepsjNAYesYesNA
Purity of the tissuekYesYesYesYes
Warm ischemia timelNAYesYesYes
Duration of cold ischemia timemNAYesYesYes
Assessment of ECDnNAYesYesYes
  • ECD, endothelial cell density; NA, not applicable.

  • a Especially for samples derived from patients with cancer.

  • b Very important also for tissues derived from living donors.

  • c Bacterial, fungal, and viral (HIV, hepatitis B and C, cytomegalovirus).

  • d Especially required for bioengineering research studies.

  • e Including the presence of alcohol or drugs in the body at time of death, macroscopic changes in the organs at time of autopsy, and evidence of hypoxia/ischemia. Blood test results from autopsy are also included in these details.

  • f Especially for studies involving several generations within the same family.

  • g NA for fresh resection after neurologic death or cardiac death.

  • h Updated regularly.

  • i RIN, tissue pH, and/or protein assay.

  • j Record of thaw/freeze cycles before it is used for research.

  • k During dissection some tissues cannot be separated properly from others and must be specified before research is conducted.

  • l The time during which a tissue/organ remains at physiologic temperature during decreased blood perfusion or in the absence of blood supply.

  • m The time during which a tissue/organ remains cold during decreased blood perfusion or in the absence of blood supply. Also the time between tissue removal and cell/tissue preparation; 1 example is islet preparation from the pancreas.

  • n Specific for research studies of eye tissue.