Sync template from atomicqms-style deployment
This commit is contained in:
192
Forms/Chain-of-Custody/FRM-BIO-002-Chain-of-Custody.md
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192
Forms/Chain-of-Custody/FRM-BIO-002-Chain-of-Custody.md
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# Chain of Custody Form
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| Form ID | FRM-BIO-002 | Revision | 1.0 |
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|---------|-------------|----------|-----|
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---
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## Specimen Information
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| Field | Entry |
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|-------|-------|
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| Specimen ID(s) | |
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| Number of Containers | |
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| Specimen Type | ☐ Blood ☐ Serum ☐ Plasma ☐ Tissue ☐ DNA ☐ RNA ☐ Cells ☐ FFPE ☐ Other: _______ |
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| Protocol/Study ID | |
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| Subject/Donor ID | |
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| Collection Date | |
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| Collection Time | |
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| Collected By | |
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---
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## Required Storage Conditions
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| Condition | Check |
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|-----------|-------|
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| ☐ Ambient (15-25°C) | |
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| ☐ Refrigerated (2-8°C) | |
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| ☐ Frozen (-20°C) | |
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| ☐ Ultra-low (-80°C) | |
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| ☐ Liquid Nitrogen (-196°C) | |
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| ☐ Other: _______ | |
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**Special Handling Instructions:**
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---
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## Chain of Custody Log
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### Transfer 1
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| Field | Entry |
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|-------|-------|
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| Released By | |
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| Title/Role | |
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| Date | |
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| Time | |
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| Signature | |
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| Location Transferred From | |
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| Storage Condition at Release | |
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| Received By | |
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| Title/Role | |
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| Date | |
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| Time | |
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| Signature | |
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| Location Transferred To | |
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| Condition on Receipt | ☐ Acceptable ☐ Compromised |
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| Notes | |
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### Transfer 2
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| Field | Entry |
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|-------|-------|
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| Released By | |
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| Title/Role | |
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| Date | |
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| Time | |
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| Signature | |
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| Location Transferred From | |
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| Storage Condition at Release | |
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| Received By | |
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| Title/Role | |
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| Date | |
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| Time | |
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| Signature | |
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| Location Transferred To | |
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| Condition on Receipt | ☐ Acceptable ☐ Compromised |
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| Notes | |
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### Transfer 3
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| Field | Entry |
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|-------|-------|
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| Released By | |
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| Title/Role | |
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| Date | |
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| Time | |
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| Signature | |
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| Location Transferred From | |
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| Storage Condition at Release | |
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| Received By | |
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| Title/Role | |
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| Date | |
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| Time | |
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| Signature | |
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| Location Transferred To | |
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| Condition on Receipt | ☐ Acceptable ☐ Compromised |
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| Notes | |
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### Transfer 4
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| Field | Entry |
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|-------|-------|
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| Released By | |
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| Title/Role | |
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| Date | |
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| Time | |
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| Signature | |
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| Location Transferred From | |
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| Storage Condition at Release | |
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| Received By | |
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| Title/Role | |
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| Date | |
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| Time | |
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| Signature | |
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| Location Transferred To | |
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| Condition on Receipt | ☐ Acceptable ☐ Compromised |
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| Notes | |
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---
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## Temperature Monitoring (for transport)
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| Time Point | Temperature | Within Range? | Initials |
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|------------|-------------|---------------|----------|
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| Departure | °C | ☐ Yes ☐ No | |
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| Checkpoint 1 | °C | ☐ Yes ☐ No | |
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| Checkpoint 2 | °C | ☐ Yes ☐ No | |
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| Arrival | °C | ☐ Yes ☐ No | |
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**Temperature Monitor ID/Lot:**
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---
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## Shipping Information (if applicable)
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| Field | Entry |
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|-------|-------|
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| Carrier | |
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| Tracking Number | |
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| Ship Date | |
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| Expected Arrival | |
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| Actual Arrival | |
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| Package Condition | ☐ Intact ☐ Damaged (describe below) |
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| Temperature Indicator Status | ☐ Within range ☐ Exceeded (describe below) |
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Condition/Temperature Notes:
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---
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## Deviation Documentation
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| Field | Entry |
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|-------|-------|
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| Was specimen condition compromised? | ☐ Yes ☐ No |
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| If yes, describe deviation: | |
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| Temperature excursion? | ☐ Yes ☐ No |
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| If yes, duration: | |
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| If yes, max/min temp: | |
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| Action taken: | |
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| Deviation Report #: | |
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| Specimen disposition: | ☐ Accepted ☐ Quarantined ☐ Rejected |
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---
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## Final Disposition
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| Field | Entry |
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|-------|-------|
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| Final Storage Location | |
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| Freezer/Tank ID | |
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| Rack/Box Position | |
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| Date/Time Stored | |
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| Stored By | |
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| LIMS Entry Completed? | ☐ Yes |
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| LIMS Accession # | |
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---
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## Verification
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| Field | Entry |
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|-------|-------|
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| Chain of custody complete? | ☐ Yes |
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| All transfers documented? | ☐ Yes |
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| Temperature maintained? | ☐ Yes ☐ No (deviation documented) |
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| Final reviewer signature | |
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| Date | |
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---
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*Form FRM-BIO-002 Rev 1.0 - Chain of Custody Form*
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156
Forms/Collection-Forms/FRM-BIO-001-Specimen-Collection-Log.md
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156
Forms/Collection-Forms/FRM-BIO-001-Specimen-Collection-Log.md
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@@ -0,0 +1,156 @@
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# Specimen Collection Log
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| Form ID | FRM-BIO-001 | Revision | 1.0 |
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|---------|-------------|----------|-----|
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---
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## Collection Session Information
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| Field | Entry |
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|-------|-------|
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| Collection Date | |
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| Collector Name | |
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| Collector ID | |
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| Collection Site/Location | |
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| Protocol/Study ID | |
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| Batch Number | |
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---
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## Specimen Collection Record
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### Specimen 1
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| Field | Entry |
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|-------|-------|
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| Specimen ID (Barcode) | |
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| Subject/Donor ID | |
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| Consent Verified? | ☐ Yes |
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| Verification Method | ☐ Wristband ☐ Verbal ☐ Photo ID ☐ Other: _______ |
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| Specimen Type | ☐ Blood ☐ Tissue ☐ Urine ☐ CSF ☐ Other: _______ |
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| Collection Container | |
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| Collection Time | : (24hr) |
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| Volume/Quantity | |
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| Collection Site (anatomical) | |
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| Ischemia Time (if tissue) | Warm: ___ min Cold: ___ min |
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| Specimen Appearance | ☐ Normal ☐ Hemolyzed ☐ Lipemic ☐ Icteric ☐ Other: _______ |
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| Notes/Deviations | |
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### Specimen 2
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| Field | Entry |
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|-------|-------|
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| Specimen ID (Barcode) | |
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| Subject/Donor ID | |
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| Consent Verified? | ☐ Yes |
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| Verification Method | ☐ Wristband ☐ Verbal ☐ Photo ID ☐ Other: _______ |
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| Specimen Type | ☐ Blood ☐ Tissue ☐ Urine ☐ CSF ☐ Other: _______ |
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| Collection Container | |
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| Collection Time | : (24hr) |
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| Volume/Quantity | |
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| Collection Site (anatomical) | |
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| Ischemia Time (if tissue) | Warm: ___ min Cold: ___ min |
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| Specimen Appearance | ☐ Normal ☐ Hemolyzed ☐ Lipemic ☐ Icteric ☐ Other: _______ |
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| Notes/Deviations | |
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### Specimen 3
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| Field | Entry |
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|-------|-------|
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| Specimen ID (Barcode) | |
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| Subject/Donor ID | |
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| Consent Verified? | ☐ Yes |
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| Verification Method | ☐ Wristband ☐ Verbal ☐ Photo ID ☐ Other: _______ |
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| Specimen Type | ☐ Blood ☐ Tissue ☐ Urine ☐ CSF ☐ Other: _______ |
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| Collection Container | |
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| Collection Time | : (24hr) |
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| Volume/Quantity | |
|
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| Collection Site (anatomical) | |
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| Ischemia Time (if tissue) | Warm: ___ min Cold: ___ min |
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| Specimen Appearance | ☐ Normal ☐ Hemolyzed ☐ Lipemic ☐ Icteric ☐ Other: _______ |
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| Notes/Deviations | |
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### Specimen 4
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| Field | Entry |
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|-------|-------|
|
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| Specimen ID (Barcode) | |
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| Subject/Donor ID | |
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| Consent Verified? | ☐ Yes |
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| Verification Method | ☐ Wristband ☐ Verbal ☐ Photo ID ☐ Other: _______ |
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| Specimen Type | ☐ Blood ☐ Tissue ☐ Urine ☐ CSF ☐ Other: _______ |
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| Collection Container | |
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| Collection Time | : (24hr) |
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| Volume/Quantity | |
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| Collection Site (anatomical) | |
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| Ischemia Time (if tissue) | Warm: ___ min Cold: ___ min |
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| Specimen Appearance | ☐ Normal ☐ Hemolyzed ☐ Lipemic ☐ Icteric ☐ Other: _______ |
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| Notes/Deviations | |
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---
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## Processing Summary
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| Field | Entry |
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|-------|-------|
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| Total Specimens Collected | |
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| Specimens with Deviations | |
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| Processing Start Time | : (24hr) |
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| Processing End Time | : (24hr) |
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| Processed By | |
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## Aliquot Summary (if applicable)
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| Specimen ID | # Aliquots | Volume Each | Storage Location | Temp |
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|-------------|------------|-------------|------------------|------|
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| | | | | |
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| | | | | |
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| | | | | |
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||||
| | | | | |
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|
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---
|
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|
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## Transfer Information
|
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| Field | Entry |
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|-------|-------|
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| Transferred To | |
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| Transfer Time | : (24hr) |
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| Transport Condition | ☐ Ambient ☐ 4°C ☐ Frozen ☐ LN2 |
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| Received By | |
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| Receipt Time | : (24hr) |
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| Condition on Receipt | ☐ Acceptable ☐ Compromised (describe below) |
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||||
|
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Notes on condition:
|
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|
||||
---
|
||||
|
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## Verification
|
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|
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| Field | Entry |
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||||
|-------|-------|
|
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| All specimens labeled correctly? | ☐ Yes |
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| All documentation complete? | ☐ Yes |
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| Any deviations reported? | ☐ Yes ☐ No ☐ N/A |
|
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| Deviation Report # (if applicable) | |
|
||||
|
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### Collector Signature
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| Field | Entry |
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|-------|-------|
|
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| Signature | |
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| Date | |
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| Time | |
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|
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### Supervisor Review (if deviations noted)
|
||||
|
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| Field | Entry |
|
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|-------|-------|
|
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| Reviewed By | |
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||||
| Date | |
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| Comments | |
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---
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*Form FRM-BIO-001 Rev 1.0 - Specimen Collection Log*
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0
Forms/Collection-Records/.gitkeep
Normal file
0
Forms/Collection-Records/.gitkeep
Normal file
0
Forms/Consent-Forms/.gitkeep
Normal file
0
Forms/Consent-Forms/.gitkeep
Normal file
0
Forms/Distribution/.gitkeep
Normal file
0
Forms/Distribution/.gitkeep
Normal file
64
Forms/FRM-001-Document-Change-Request.md
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64
Forms/FRM-001-Document-Change-Request.md
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@@ -0,0 +1,64 @@
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# Document Change Request Form
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||||
|
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| Form ID | FRM-001 | Revision | 1.0 |
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|---------|---------|----------|-----|
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||||
|
||||
---
|
||||
|
||||
## Section 1: Request Information
|
||||
|
||||
| Field | Entry |
|
||||
|-------|-------|
|
||||
| Request Date | |
|
||||
| Requested By | |
|
||||
| Department | |
|
||||
|
||||
## Section 2: Document Information
|
||||
|
||||
| Field | Entry |
|
||||
|-------|-------|
|
||||
| Document Number | |
|
||||
| Document Title | |
|
||||
| Current Revision | |
|
||||
|
||||
## Section 3: Change Description
|
||||
|
||||
### Type of Change
|
||||
- [ ] New Document
|
||||
- [ ] Revision to Existing Document
|
||||
- [ ] Document Obsolescence
|
||||
|
||||
### Description of Change
|
||||
*(Describe the proposed change in detail)*
|
||||
|
||||
|
||||
|
||||
|
||||
### Reason for Change
|
||||
*(Explain why this change is needed)*
|
||||
|
||||
|
||||
|
||||
|
||||
## Section 4: Impact Assessment
|
||||
|
||||
### Affected Areas
|
||||
- [ ] Training Required
|
||||
- [ ] Other Documents Affected
|
||||
- [ ] Process Changes Required
|
||||
- [ ] Validation Impact
|
||||
|
||||
### List Affected Documents
|
||||
|
||||
|
||||
## Section 5: Approvals
|
||||
|
||||
| Role | Name | Signature | Date |
|
||||
|------|------|-----------|------|
|
||||
| Requester | | | |
|
||||
| Document Owner | | | |
|
||||
| Quality Assurance | | | |
|
||||
|
||||
---
|
||||
|
||||
*Form FRM-001 Rev 1.0*
|
||||
91
Forms/FRM-003-CAPA-Form.md
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91
Forms/FRM-003-CAPA-Form.md
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@@ -0,0 +1,91 @@
|
||||
# Corrective and Preventive Action (CAPA) Form
|
||||
|
||||
| Form ID | FRM-003 | Revision | 1.0 |
|
||||
|---------|---------|----------|-----|
|
||||
|
||||
---
|
||||
|
||||
## Section 1: CAPA Identification
|
||||
|
||||
| Field | Entry |
|
||||
|-------|-------|
|
||||
| CAPA Number | |
|
||||
| Date Initiated | |
|
||||
| Initiated By | |
|
||||
| CAPA Owner | |
|
||||
| Target Closure Date | |
|
||||
|
||||
## Section 2: Classification
|
||||
|
||||
### Type
|
||||
- [ ] Corrective Action
|
||||
- [ ] Preventive Action
|
||||
|
||||
### Source
|
||||
- [ ] Customer Complaint
|
||||
- [ ] Internal Audit
|
||||
- [ ] External Audit
|
||||
- [ ] Process Deviation
|
||||
- [ ] Nonconforming Product
|
||||
- [ ] Management Review
|
||||
- [ ] Other: ____________
|
||||
|
||||
### Priority
|
||||
- [ ] Critical (5 business days)
|
||||
- [ ] Major (15 business days)
|
||||
- [ ] Minor (30 business days)
|
||||
|
||||
## Section 3: Problem Description
|
||||
|
||||
*(Describe the nonconformity or potential nonconformity)*
|
||||
|
||||
|
||||
|
||||
|
||||
## Section 4: Immediate Containment
|
||||
|
||||
*(Actions taken to contain the immediate impact)*
|
||||
|
||||
|
||||
|
||||
|
||||
## Section 5: Root Cause Investigation
|
||||
|
||||
### Investigation Method Used
|
||||
- [ ] 5 Whys
|
||||
- [ ] Fishbone Diagram
|
||||
- [ ] Fault Tree Analysis
|
||||
- [ ] Other: ____________
|
||||
|
||||
### Root Cause Determination
|
||||
|
||||
|
||||
|
||||
|
||||
## Section 6: Corrective/Preventive Actions
|
||||
|
||||
| Action | Responsible | Due Date | Status |
|
||||
|--------|-------------|----------|--------|
|
||||
| | | | |
|
||||
| | | | |
|
||||
| | | | |
|
||||
|
||||
## Section 7: Effectiveness Verification
|
||||
|
||||
| Criteria | Method | Result |
|
||||
|----------|--------|--------|
|
||||
| | | |
|
||||
|
||||
Verification Date: ____________
|
||||
Verified By: ____________
|
||||
|
||||
## Section 8: Closure
|
||||
|
||||
| Role | Name | Signature | Date |
|
||||
|------|------|-----------|------|
|
||||
| CAPA Owner | | | |
|
||||
| Quality Approval | | | |
|
||||
|
||||
---
|
||||
|
||||
*Form FRM-003 Rev 1.0*
|
||||
56
Forms/FRM-006-Audit-Checklist.md
Normal file
56
Forms/FRM-006-Audit-Checklist.md
Normal file
@@ -0,0 +1,56 @@
|
||||
# Internal Audit Checklist
|
||||
|
||||
| Form ID | FRM-006 | Revision | 1.0 |
|
||||
|---------|---------|----------|-----|
|
||||
|
||||
---
|
||||
|
||||
## Audit Information
|
||||
|
||||
| Field | Entry |
|
||||
|-------|-------|
|
||||
| Audit Number | |
|
||||
| Audit Date | |
|
||||
| Area/Process Audited | |
|
||||
| Lead Auditor | |
|
||||
| Auditee(s) | |
|
||||
|
||||
---
|
||||
|
||||
## Checklist Items
|
||||
|
||||
| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
|
||||
|---|---------------------|-----------|---------|----------------|
|
||||
| 1 | Are current versions of applicable procedures available? | SOP-001 | | |
|
||||
| 2 | Are personnel trained on applicable procedures? | SOP-003 | | |
|
||||
| 3 | Are training records current and complete? | SOP-003 | | |
|
||||
| 4 | Are records properly maintained and retrievable? | SOP-001 | | |
|
||||
| 5 | Are nonconformities being documented and addressed? | SOP-002 | | |
|
||||
| 6 | Are CAPAs being completed on time? | SOP-002 | | |
|
||||
| 7 | Is equipment calibrated and maintained? | | | |
|
||||
| 8 | Are process controls being followed? | | | |
|
||||
| 9 | Are quality objectives being monitored? | | | |
|
||||
| 10 | | | | |
|
||||
|
||||
**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable
|
||||
|
||||
---
|
||||
|
||||
## Findings Summary
|
||||
|
||||
| Finding # | Type | Description | Clause Reference |
|
||||
|-----------|------|-------------|------------------|
|
||||
| | | | |
|
||||
| | | | |
|
||||
|
||||
---
|
||||
|
||||
## Auditor Signature
|
||||
|
||||
| Auditor | Signature | Date |
|
||||
|---------|-----------|------|
|
||||
| | | |
|
||||
|
||||
---
|
||||
|
||||
*Form FRM-006 Rev 1.0*
|
||||
0
Forms/QC-Records/.gitkeep
Normal file
0
Forms/QC-Records/.gitkeep
Normal file
0
Forms/Storage-Logs/.gitkeep
Normal file
0
Forms/Storage-Logs/.gitkeep
Normal file
72
Forms/Training/FRM-004-Training-Record.md
Normal file
72
Forms/Training/FRM-004-Training-Record.md
Normal file
@@ -0,0 +1,72 @@
|
||||
# Training Record Form
|
||||
|
||||
| Form ID | FRM-004 | Revision | 1.0 |
|
||||
|---------|---------|----------|-----|
|
||||
|
||||
---
|
||||
|
||||
## Section 1: Employee Information
|
||||
|
||||
| Field | Entry |
|
||||
|-------|-------|
|
||||
| Employee Name | |
|
||||
| Employee ID | |
|
||||
| Department | |
|
||||
| Job Title | |
|
||||
|
||||
## Section 2: Training Information
|
||||
|
||||
| Field | Entry |
|
||||
|-------|-------|
|
||||
| Training Title | |
|
||||
| Training Date | |
|
||||
| Training Duration | |
|
||||
| Trainer Name | |
|
||||
| Trainer Qualification | |
|
||||
|
||||
### Training Type
|
||||
- [ ] Initial Training
|
||||
- [ ] Retraining
|
||||
- [ ] Refresher
|
||||
- [ ] Procedure Update
|
||||
|
||||
### Delivery Method
|
||||
- [ ] Classroom
|
||||
- [ ] On-the-Job
|
||||
- [ ] Self-Study
|
||||
- [ ] Computer-Based
|
||||
- [ ] Other: ____________
|
||||
|
||||
## Section 3: Training Content
|
||||
|
||||
*(List topics covered or attach training materials)*
|
||||
|
||||
|
||||
|
||||
|
||||
## Section 4: Assessment
|
||||
|
||||
### Assessment Method
|
||||
- [ ] Written Test
|
||||
- [ ] Practical Demonstration
|
||||
- [ ] Verbal Assessment
|
||||
- [ ] Observation
|
||||
|
||||
### Assessment Results
|
||||
|
||||
| Metric | Result |
|
||||
|--------|--------|
|
||||
| Score (if applicable) | |
|
||||
| Pass/Fail | |
|
||||
|
||||
## Section 5: Signatures
|
||||
|
||||
| Role | Name | Signature | Date |
|
||||
|------|------|-----------|------|
|
||||
| Trainee | | | |
|
||||
| Trainer | | | |
|
||||
| Supervisor | | | |
|
||||
|
||||
---
|
||||
|
||||
*Form FRM-004 Rev 1.0*
|
||||
Reference in New Lab Ticket
Block a user