# Ordered Plan

## 1. Immediate enrollment and intervention holds

As of Wednesday 10:00 a.m., NovaCrest should immediately:

- **Pause all new enrollment** into the study at all five sites until each site confirms which consent form is currently in use and the ethics board approves corrected materials.
- **Pause all nonurgent research interventions**, including all 12 scheduled implantations, until the actual signed consent version is verified for each subject.
  - The **4 confirmed version-4.2 subjects** must not proceed until they sign an ethics-board-approved corrected consent form.
  - The **8 subjects with unknown consent versions** must not proceed until the site produces and verifies the signed form. If the form is version 4.2, re-consent is required. If the form is confirmed version 4.1 or 4.3, the v4.2-based pause would not apply, but no site should proceed until verification is documented and any broader board/site hold is followed.
- **Quarantine all version-4.2 consent forms** and any forms of unverified version so they cannot be used again.
- **Reject the investigators’ “email afterward” proposal.** An email after implantation cannot cure the lack of prospective informed consent; it is not a substitute for an approved corrected consent form signed before the next nonurgent intervention.

## 2. Care and safety follow-up

- **Continue medically necessary care and safety follow-up.** Do not withhold care to preserve the pause.
- The **six routine safety visits this week** should proceed to the extent they are needed for subject safety and follow-up. Purely research-only procedures that are not needed for safety and can be deferred should be deferred until the consent question is resolved.
- Continue adverse-event monitoring and clinical management, including for the subject who experienced temporary nerve weakness.
- No subject should be abandoned or denied follow-up because of the consent-form defect.

## 3. Investigation: records needed to determine scope

Build a subject-by-subject consent-version reconciliation for all 120 subjects. For each subject, collect:

- Site and subject identifier.
- Actual signed consent version (4.1, 4.2, 4.3, or other).
- Date of consent.
- Signed PDF/original form, including all signatures.
- Site consent log and version-distribution log.
- Whether any later re-consent or amendment was signed.
- Database upload timestamp and metadata.
- Correspondence showing which consent versions were sent to each site and when.
- Approval history for each consent version, including whether v4.2 was ever approved.

For the **62 unknown subjects**, obtain the missing signed PDFs directly from the sites. Do **not** infer consent version from enrollment dates or from the central database. For the **38 confirmed v4.2 subjects at Site A**, obtain supporting source records, not just the site’s confirmation. For the **20 subjects confirmed on v4.1/v4.3**, document the source evidence as well.

Do not tell the ethics board or regulator that all 62 unknown subjects were affected, and do not tell them none were affected. They are **under verification**. Current confirmed status is: 38 v4.2, 20 v4.1/v4.3, 62 unverified.

## 4. Ethics-board and regulator reporting clocks

- **Notify the central ethics board immediately**, not merely by the deadline. Request the emergency review for tomorrow.
- The formal noncompliance report to the ethics board must be filed **within five business days after discovery**. Do not wait for that deadline.
- The device regulator report must be filed **within seven calendar days after discovery**. File as soon as possible; do not wait for the full seven days or for the investigation to be complete.
- The ethics review and regulator reporting are separate obligations. Board approval of corrected materials does not satisfy the regulator reporting obligation.
- Instruct each site to check its own approved plan for any **faster local reporting requirement** and to comply. No faster local period is given, but sites should verify.

The initial regulator/board report should state:

- The document-conversion error that caused v4.2 to omit the 3% nerve-weakness risk.
- Discovery time and date.
- Confirmed counts: 38 v4.2, 20 v4.1/v4.3, 62 pending verification.
- The known nerve-weakness adverse event in a v4.2 subject.
- Immediate holds and preservation steps.
- The corrective-consent plan.

## 5. Emergency approval of corrected materials

- Prepare a **corrected informed consent form** that restores the required risk disclosure: temporary nerve weakness, occurring in approximately 3% of subjects.
- A new version is preferable, e.g., version 4.4, clearly marked as correcting v4.2. If v4.3 is already approved and otherwise appropriate, the board may approve it as the corrected form, but a distinct version/amendment is cleaner and less confusing.
- Also prepare a short **notice and consent-choice document** for subjects who already completed intervention, explaining:
  - the omitted risk;
  - that version 4.2 was defective;
  - the options regarding continued safety follow-up and data use.
- Submit both to the central ethics board for emergency approval tomorrow.
- **No corrected form may be used before written ethics-board approval.**

## 6. Re-consent of subjects awaiting intervention

After the board approves corrected materials:

- For any subject confirmed to have signed v4.2 who has not completed study interventions, obtain re-consent on the approved corrected form **before the next nonurgent intervention**.
- The consent process must be genuine:
  - in-person discussion;
  - opportunity to ask questions;
  - a copy of the corrected form;
  - voluntary signature and date;
  - no backdating;
  - no “email afterward” substitute.
- If the subject declines re-consent, do not perform the research intervention. Continue medically necessary care and safety follow-up.
- For the 8 scheduled subjects with unknown consent versions, first verify what they signed:
  - If v4.2 → hold and re-consent.
  - If v4.1/v4.3 → the v4.2-based hold does not apply, but the site must document verification and follow any broader board/site hold.

## 7. Notice and consent choices for subjects who completed intervention

For subjects who already completed the implantation procedure and are confirmed to have signed v4.2:

- Provide the board-approved notice of the omitted risk.
- Explain that temporary nerve weakness was a known protocol risk and that the consent form they signed omitted it.
- Explain that this may affect their willingness to continue follow-up or permit continued use of their data.
- Give them a clear choice:
  - continue in follow-up and permit continued data use;
  - decline further data use, if feasible;
  - ask questions or speak with the investigator.
- Document their choice.
- **Do not backdate their old consent form, and do not recreate records as if the risk had been disclosed earlier.**
- Continue medical care and safety follow-up regardless of their data-choice.
- For completed subjects whose consent version remains unknown after investigation, do not assume they are unaffected. If the version cannot be confirmed, treat them as potentially affected and seek ethics-board guidance; in the interim, provide the notice if the board permits.

## 8. Treatment of previously collected data

- **Do not discard, delete, or destroy any previously collected data.**
- The ethics board decides continued use of data from v4.2 subjects, considering:
  - risk to subjects;
  - subject wishes;
  - scientific integrity;
  - the nature of the noncompliance.
- If a subject objects to continued data use, segregate that subject’s data from future research use and preserve it pending board/regulator direction.
- Preserve all records even if the board later restricts data use.

## 9. Known nerve-weakness event

- Continue to provide appropriate care and follow-up for the affected subject.
- Confirm that the event was properly reported through the ordinary safety-channel reporting process.
- Report the event again, or cross-reference it, in the consent-noncompliance report because it demonstrates the materiality of the omission.
- Directly disclose to that subject that the nerve weakness was a known risk and was omitted from the consent form due to the v4.2 error.
- Do not treat the ordinary adverse-event report as satisfying the consent-noncompliance reporting obligation.

## 10. Preservation, privilege, and the proposed PDF replacement

- Issue an immediate **litigation hold / preservation notice** to all sponsor staff, sites, IT, and CROs.
- Preserve:
  - every consent version;
  - every signed consent form;
  - site logs;
  - database timestamps;
  - emails and communications;
  - adverse-event records;
  - all data records.
- **Do not replace version-4.2 PDFs with version 4.3 in the database.** The CSO’s proposal is unacceptable. It would destroy evidence, falsify the audit trail, and could turn this into a record-falsification matter. The v4.2 files must remain intact; corrections should be made by adding a new approved version and documenting the correction.
- **Separate privileged legal analysis from operational fact-gathering.** Facts and records are not privileged merely because counsel is involved. Privilege does not excuse timely reporting or candor to the ethics board and regulator.
- Do not instruct sites to withhold documents or to “clean” files.

## 11. Concrete sequence: next 72 hours and seven days

### Day 0 — Wednesday

- Immediately:
  - issue the enrollment and intervention hold;
  - issue preservation notice;
  - quarantine v4.2/unverified forms;
  - notify the ethics board and request emergency review tomorrow;
  - begin drafting regulator report;
  - direct sites to verify the 12 scheduled subjects and the remaining subject records.
- Continue safety visits and adverse-event monitoring.
- No scheduled implant proceeds today unless the site confirms a v4.1/v4.3 signed form and no broader hold applies.

### Day 1 — Thursday

- Attend the central ethics board emergency review.
- Submit:
  - corrected consent form;
  - notice/choice form for completed subjects;
  - factual summary of the noncompliance;
  - current scope status: 38 v4.2, 20 v4.1/v4.3, 62 pending.
- If approved, distribute the corrected form to sites.
- For scheduled v4.2/unconfirmed subjects, begin the re-consent process, but **do not implant until the corrected form is signed**.
- Continue verification of the 62 unknown subjects.

### Days 2–3 — Friday through Saturday

- Complete verification for as many subjects as possible.
- Re-consent v4.2 subjects awaiting intervention before any rescheduled implant.
- Send the board-approved notice to confirmed completed v4.2 subjects.
- The six routine safety visits proceed as safety follow-up.
- File the regulator report as soon as practicable; do not wait for the seven-day deadline.

### By the five-business-day deadline

- File the full central ethics board noncompliance report.
- Include:
  - confirmed subject counts;
  - still-unverified counts, if any;
  - corrective actions;
  - the nerve-weakness event;
  - the preservation plan;
  - the re-consent and notice status.

### By the seven-calendar-day deadline

- File the device regulator report.
- If the scope is not fully resolved, file an interim report with confirmed facts and the plan for verification, then supplement as soon as additional information is available.

### Ongoing

- Continue care and safety follow-up.
- Continue re-consent and notice processes.
- Await the ethics board’s decision on continued use of previously collected data.
- Preserve all records and do not modify the audit trail.