This is a ready-to-use record for certifying a copy so it can stand in for an original, and for documenting the original’s disposition. A copy becomes a certified copy only when someone confirms, by a dated signature or a validated process, that it carries everything the original carries, including its context, content, and structure. Replace every <<FILL: ...>> placeholder with your specifics. A worked filled specimen follows.
Document control header
| Field | Entry |
|---|---|
| Record title | Certified Copy Certification and Original Retirement |
| Record number | <<FILL: e.g. CCR-<protocol>-0007>> |
| Parent SOP | <<FILL: SOP-ID for certified copies / source records>> |
| Protocol / study | <<FILL>> |
| Subject / record ID | <<FILL>> |
| Date | <<FILL>> |
1. Purpose
This record certifies that the copy described below is a true and complete copy of the original source record for <<FILL: subject / record>>, and documents whether the original was retained or retired. It exists so that a copy relied on as source is demonstrably faithful, and so that no original is destroyed without a confirmed, defensible replacement.
2. Record being copied
| Field | Entry |
|---|---|
| Original record type | <<FILL: e.g. EHR progress notes, ECG tracing, lab report>> |
| Original media | <<FILL: paper / electronic / imaging>> |
| Is the original dynamic (audit trail, metadata, calculations)? | Yes / No |
| Reason for copying | <<FILL: file to trial file / scan to DMS / retire paper>> |
3. Copy method
| Field | Entry |
|---|---|
| Certification route | Manual (person compares and signs) / Validated process |
| Copy method | <<FILL: controlled scanner settings, no cropping, color where meaningful>> |
| Validated-process reference (if used) | <<FILL: validation record ID, or N/A>> |
4. Completeness and context checks
| Check | Result |
|---|---|
| Original was complete and final before copying (no pending entries) | Yes / No |
| Copy compared to original page by page, including back pages and annotations | Yes / No |
| Copy is legible throughout | Yes / No |
| Color preserved where it carries meaning (e.g. a flagged lab value) | Yes / No / N/A |
| For a dynamic electronic original: audit trail and metadata preserved or separately retained | Yes / No / N/A |
A static print or scan that drops the audit trail, metadata, or dynamic functionality of an electronic original is not a faithful certified copy of that record.
5. Certification statement
I certify that the copy described above is a true and complete copy of the original record, carrying the same information, context, content, and structure as the original.
| Field | Entry |
|---|---|
| Certified by (name, role) | <<FILL>> |
| Signature | |
| Date | <<FILL>> |
6. Original disposition
| Field | Entry |
|---|---|
| Original retained? | Yes / No |
| If retired: procedures and applicable law permit retirement? | Yes / No |
| If retired: date and method of disposal | <<FILL>> |
| Certified copy retained at | <<FILL: location / record ID>> |
| Retention period applied | <<FILL>> |
7. Acceptance criteria
A copy qualifies as certified when all are true:
- It is complete (every page, every annotation) and legible.
- It preserves context, content, and structure, including audit trail and metadata for a dynamic original.
- It bears a dated signature or links to a documented validated-process record.
- The original is only retired where a faithful certified copy exists and procedures and law allow it.
8. References
ICH E6(R2)/E6(R3) Good Clinical Practice (certified copy definition). MHRA GxP Data Integrity Guidance and Definitions; PIC/S PI 041 (true copies). 21 CFR Part 11 (electronic records); 21 CFR 312.62 (investigator records).
Confirm the current version of each reference before issue.
Filled specimen
The following shows the record completed for an example EHR-sourced adverse-event note copied into the trial file. The specifics are illustrative.
- Record: EHR progress notes documenting a serious adverse event for subject 0210; original media electronic; dynamic (carries an EHR audit trail).
- Reason: file a certified copy in the investigator site file, as the sponsor cannot access the hospital EHR directly.
- Method: manual certification; PDF exported from the EHR including the entry’s audit-trail view and metadata, exported by the coordinator using the EHR’s controlled export, no cropping.
- Checks: original complete and final; compared page by page; legible; audit trail and metadata included in the export; color not applicable.
- Certification: “I certify this is a true and complete copy…” signed by M. Rivera (study coordinator), dated 12 July 2026.
- Disposition: original EHR record retained by the hospital (not retired); certified copy filed in the ISF at TAB AE-0210; retention per the study’s essential-records rule.
In this example the copy preserved the EHR audit-trail view, so it is a faithful certified copy of a dynamic record rather than a flat screenshot that would have dropped the very context an inspector needs to reconstruct the event. The original was not retired, because it lives in the hospital system, so the record simply documents a faithful copy in the trial file.
Common findings this record prevents
- A scan with no certification statement relied on as source.
- A flat PDF of a dynamic record that dropped the audit trail and metadata, then the original destroyed, leaving no defensible source.
- An original retired with no confirmation that a faithful copy exists or that law permits it.
- A “validated process” claim with no validation record behind it.
How to adapt this form
- Point the parent-SOP field at your certified-copy or records procedure.
- Use the manual route for one-off copies and the validated-process route for high-volume scanning into a document management system.
- For dynamic electronic originals, define how the audit trail and metadata are preserved before you certify.
- Never retire an original until this record confirms a faithful copy exists and retirement is permitted.