Recommended Clinical Data Set to Accompany Solid Tissue
| Clinical Data | Biopsy/Surgical | Postmortem | Organ or Tissue Donor | Otherwise Discarded |
|---|---|---|---|---|
| Ethics approval no. | Yes | Yes | Yes | Yes |
| Consent/assent on file | Yes | Yes | Yes | Yes |
| Authorization document for tissue transfer/disclosure of Information Form on file | Yes | Yes | Yes | Yes |
| Underlying disorder | Yes | Yes | Yes | Yes |
| Stage of disease/treatment statusa | Yes | Yes | Yesb | Yes |
| Age | Yes | Yes | Yes | Yes |
| Gender | Yes | Yes | Yes | Yes |
| Ethnicity | Yes | Yes | Yes | Yes |
| Active infectionc | Yes | Yes | Yes | Yes |
| Weight, height, and BMId | Yes | Yes | Yes | Yes |
| Medical history | Yes | Yes | Yes | Yes |
| Comorbidities | Yes | Yes | Yes | Yes |
| Medications | Yes | Yes | Yes | Yes |
| Cause of death | NA | Yes | Yes | NA |
| Agonal stage/survival time | NA | Yes | Yes | NA |
| Autopsy findings detailse | NA | Yes | Yes | Yes |
| Family historyf | Yes | Yes | Yes | Yes |
| Age of mother/gestational age of fetus | NA | Yes | Yes | Yes |
| Access to other tissues from same patient | NA | Yes | Yes | Yes |
| Access to patient-matched healthy control tissue/or patient-matched nonmalignant tissue | Yes | Yes | Yes | Yes |
| Reason for not suitable for transplantation | NA | Yes | Yes | Yes |
| Isolation site | Yes | Yes | Yes | Yes |
| PMI | NA | Yes | Yesg | NA |
| Processing protocol | Yes | Yes | Yes | Yes |
| Storage protocol | Yes | Yes | Yes | Yes |
| Shipping system available | Yes | Yes | Yes | Yes |
| Storage timeh | Yes | Yes | Yes | Yes |
| Tissue integrity markeri | NA | Yes | Yesb | NA |
| Freeze/thaw stepsj | NA | Yes | Yes | NA |
| Purity of the tissuek | Yes | Yes | Yes | Yes |
| Warm ischemia timel | NA | Yes | Yes | Yes |
| Duration of cold ischemia timem | NA | Yes | Yes | Yes |
| Assessment of ECDn | NA | Yes | Yes | Yes |
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.