Chain of Custody Form
| Form ID |
FRM-BIO-002 |
Revision |
1.0 |
Specimen Information
| Field |
Entry |
| Specimen ID(s) |
|
| Number of Containers |
|
| Specimen Type |
☐ Blood ☐ Serum ☐ Plasma ☐ Tissue ☐ DNA ☐ RNA ☐ Cells ☐ FFPE ☐ Other: _______ |
| Protocol/Study ID |
|
| Subject/Donor ID |
|
| Collection Date |
|
| Collection Time |
|
| Collected By |
|
Required Storage Conditions
| Condition |
Check |
| ☐ Ambient (15-25°C) |
|
| ☐ Refrigerated (2-8°C) |
|
| ☐ Frozen (-20°C) |
|
| ☐ Ultra-low (-80°C) |
|
| ☐ Liquid Nitrogen (-196°C) |
|
| ☐ Other: _______ |
|
Special Handling Instructions:
Chain of Custody Log
Transfer 1
| Field |
Entry |
| Released By |
|
| Title/Role |
|
| Date |
|
| Time |
|
| Signature |
|
| Location Transferred From |
|
| Storage Condition at Release |
|
| Received By |
|
| Title/Role |
|
| Date |
|
| Time |
|
| Signature |
|
| Location Transferred To |
|
| Condition on Receipt |
☐ Acceptable ☐ Compromised |
| Notes |
|
Transfer 2
| Field |
Entry |
| Released By |
|
| Title/Role |
|
| Date |
|
| Time |
|
| Signature |
|
| Location Transferred From |
|
| Storage Condition at Release |
|
| Received By |
|
| Title/Role |
|
| Date |
|
| Time |
|
| Signature |
|
| Location Transferred To |
|
| Condition on Receipt |
☐ Acceptable ☐ Compromised |
| Notes |
|
Transfer 3
| Field |
Entry |
| Released By |
|
| Title/Role |
|
| Date |
|
| Time |
|
| Signature |
|
| Location Transferred From |
|
| Storage Condition at Release |
|
| Received By |
|
| Title/Role |
|
| Date |
|
| Time |
|
| Signature |
|
| Location Transferred To |
|
| Condition on Receipt |
☐ Acceptable ☐ Compromised |
| Notes |
|
Transfer 4
| Field |
Entry |
| Released By |
|
| Title/Role |
|
| Date |
|
| Time |
|
| Signature |
|
| Location Transferred From |
|
| Storage Condition at Release |
|
| Received By |
|
| Title/Role |
|
| Date |
|
| Time |
|
| Signature |
|
| Location Transferred To |
|
| Condition on Receipt |
☐ Acceptable ☐ Compromised |
| Notes |
|
Temperature Monitoring (for transport)
| Time Point |
Temperature |
Within Range? |
Initials |
| Departure |
°C |
☐ Yes ☐ No |
|
| Checkpoint 1 |
°C |
☐ Yes ☐ No |
|
| Checkpoint 2 |
°C |
☐ Yes ☐ No |
|
| Arrival |
°C |
☐ Yes ☐ No |
|
Temperature Monitor ID/Lot:
Shipping Information (if applicable)
| Field |
Entry |
| Carrier |
|
| Tracking Number |
|
| Ship Date |
|
| Expected Arrival |
|
| Actual Arrival |
|
| Package Condition |
☐ Intact ☐ Damaged (describe below) |
| Temperature Indicator Status |
☐ Within range ☐ Exceeded (describe below) |
Condition/Temperature Notes:
Deviation Documentation
| Field |
Entry |
| Was specimen condition compromised? |
☐ Yes ☐ No |
| If yes, describe deviation: |
|
| Temperature excursion? |
☐ Yes ☐ No |
| If yes, duration: |
|
| If yes, max/min temp: |
|
| Action taken: |
|
| Deviation Report #: |
|
| Specimen disposition: |
☐ Accepted ☐ Quarantined ☐ Rejected |
Final Disposition
| Field |
Entry |
| Final Storage Location |
|
| Freezer/Tank ID |
|
| Rack/Box Position |
|
| Date/Time Stored |
|
| Stored By |
|
| LIMS Entry Completed? |
☐ Yes |
| LIMS Accession # |
|
Verification
| Field |
Entry |
| Chain of custody complete? |
☐ Yes |
| All transfers documented? |
☐ Yes |
| Temperature maintained? |
☐ Yes ☐ No (deviation documented) |
| Final reviewer signature |
|
| Date |
|
Form FRM-BIO-002 Rev 1.0 - Chain of Custody Form
