biobank-repository/Forms/Chain-of-Custody/FRM-BIO-002-Chain-of-Custody.md

# 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:**

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## 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 # | |

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## Verification

| Field | Entry |
|-------|-------|
| Chain of custody complete? | ☐ Yes |
| All transfers documented? | ☐ Yes |
| Temperature maintained? | ☐ Yes ☐ No (deviation documented) |
| Final reviewer signature | |
| Date | |

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*Form FRM-BIO-002 Rev 1.0 - Chain of Custody Form*