# NovaCrest Research — Consent Noncompliance Response Plan **Privileged & Confidential / Attorney Work Product (legal-analysis sections only; factual sections are non-privileged and reportable)** **Discovery event:** Wednesday, 10:00 a.m. — omission of the 3% temporary-nerve-weakness paragraph from consent version 4.2 (document-conversion error). All clocks run from that timestamp. --- ## PART 1 — HOUR 0 TO HOUR 4 (Wednesday, 10:00 a.m.–2:00 p.m.) ### Step 1. Issue a written, study-wide stop order (within 60 minutes) Sponsor-signed notice to all five PIs, coordinators, monitors, and the CRO, with read-receipt and telephone confirmation from each site: **1a. Enrollment hold — all five sites, immediately.** - No new subject may be consented or enrolled at any site. - The hold is not limited to sites known to have used 4.2. Because version control itself has failed and 62 subjects' versions are unverified, NovaCrest cannot presently certify which form any site is handing to new subjects. A study-wide pause is the only posture consistent with Rule 2 and Rule 9 (no assuming "all" or "none"). Enrollment resumes site-by-site only after (i) the ethics board approves corrected materials, and (ii) that site's document control is verified. **1b. Nonurgent research intervention hold.** - All 12 implantations scheduled in the next 72 hours are postponed. This includes the 4 confirmed 4.2 subjects **and** the 8 unknown-version subjects. Postponing the 8 is not an assumption that they signed 4.2; it is a per-subject hold pending individual record verification and re-consent. - No other nonurgent research-only procedure (research imaging, protocol-only testing, optional sub-studies) on any subject whose consent version is unconfirmed or confirmed as 4.2. - The facts state that no urgent medical need depends on the research schedule, so no implant qualifies for an urgent-care exception. If a specific subject's treating physician documents a genuine urgent clinical indication, that is handled as clinical care under clinical consent that includes the nerve-weakness risk — not as a research intervention under a defective form. **1c. Reject the investigators' proposal.** Implanting now and emailing an explanation afterward is prohibited. Consent must precede the intervention (Rule 1), the intervention must stop until corrected materials are approved (Rule 2), and re-consent must occur *before* the next nonurgent intervention (Rule 5). A retrospective email cannot cure a pre-procedure disclosure failure and would convert a document error into a knowing violation. Communicate this refusal in writing to each PI; document any pushback. ### Step 2. Litigation/document hold and refusal of the PDF replacement (within 60 minutes) **2a. Deny the CSO's instruction outright.** Replacing version-4.2 PDFs with 4.3 would destroy the evidence of what each subject actually signed, defeat scope determination, and overwrite the audit trail — a direct violation of Rule 8 and, in substance, falsification of research records. It is also self-defeating: it would make it impossible to prove which subjects were *not* affected. Issue a written directive from counsel to the CSO, database administrator, and all sites: **no document may be replaced, renamed, re-uploaded over, deleted, or "cleaned."** **2b. Technical lockdown.** Immediately (i) revoke write/delete permissions on the consent document repository for all but two named custodians; (ii) take a forensic snapshot/backup of the eTMF, EDC, and document-management system with hash verification; (iii) suspend auto-purge and email retention deletion rules; (iv) run an audit-log query for any deletion, overwrite, or metadata change to consent documents between the 4.2 effective date and now. **2c. If any replacement already occurred:** restore from backup, preserve both states, log the incident, and disclose it to the ethics board and the regulator as part of the noncompliance report. Concealment is a far larger problem than the original conversion error. **2d. Preservation notice** to all custodians covering: every consent version (4.0–4.3) and its source/converted files, all signed forms (wet-ink originals at sites and scans), site consent logs, screening/enrollment logs, delegation logs, EDC and eTMF audit trails and timestamps, the conversion-tool logs, distribution emails to sites, monitoring reports, and all internal communications about 4.2 — including the CSO's instruction and this response. ### Step 3. Convene the emergency board review and open the reporting file - Accept the offer of an emergency central ethics board session **tomorrow (Thursday)**; confirm the slot in writing this afternoon. - Open a single factual chronology document, owned by QA/Clinical (not counsel), that will be the backbone of both the board and regulator reports. - Instruct each site in writing to check its own approved plan and local requirements for **any faster local reporting period** and to report accordingly; no faster period has been identified centrally, but sites must not assume none applies. Sponsor will supply the confirmed facts within 24 hours so sites can meet any shorter local clock. --- ## PART 2 — CARE AND SAFETY THAT MUST CONTINUE (starting immediately) The study pause is a pause on *enrollment and nonurgent research interventions*, not on patient care (Rule 3). 1. **The six routine safety visits this week go forward.** They are safety follow-up, not discretionary research. Conduct the clinical safety assessment (including focused neurologic examination for implanted subjects), record adverse events, and manage findings. Defer any research-only add-on collected at that visit for a subject whose version is 4.2 or unconfirmed until re-consent or board direction; document the deferral. 2. **All implanted subjects retain full access to clinical care**, device interrogation and reprogramming, explant or revision if medically indicated, infection and neurologic management, and referral. None of this requires research re-consent. 3. **Enhanced neurologic surveillance for the 38 confirmed 4.2 subjects** and any additional 4.2 subjects identified during scope work: proactive outreach call within 72 hours asking about weakness, numbness, or motor change; expedited evaluation offered to any symptomatic subject. 4. **Postponed-implant subjects are not abandoned.** Each of the 12 receives a personal call (not a form email) within 24 hours from the PI or a delegated clinician: the procedure is delayed for a consent-document correction, the newly disclosed risk, what the delay means clinically, alternatives including non-study treatment, and a named contact. Any subject whose clinical condition cannot tolerate delay is transitioned to clinical care pathways rather than pushed through the study. 5. **24/7 sponsor medical monitor line** activated and communicated to all sites and to subjects contacted. --- ## PART 3 — REPORTING CLOCKS (calculate conservatively; do not use the full period) **Discovery: Wednesday 10:00 a.m.** | Report | Rule | Outer deadline | NovaCrest target | |---|---|---|---| | Central ethics board — material consent noncompliance | 5 business days | Following **Wednesday**, COB (counting Thursday as day 1). If the board's convention counts the discovery day, the deadline is **Tuesday** — plan to the earlier date. | **Thursday**, with the emergency-review package (day 1) | | Device regulator — material consent noncompliance | 7 calendar days | Following **Wednesday**. If the discovery day counts as day 1, **Tuesday** — plan to the earlier date. | **Friday**; hard internal cutoff **Monday** | | Site-level local reports | Site's approved plan | No faster period supplied; each site must verify and report | Facts delivered to sites within 24 hours | Key points: - **Do not delay either report to finish scope determination.** Report the known facts with an explicit statement of what is confirmed, what is unknown, the number in each category (38 confirmed 4.2 / 20 confirmed 4.1–4.3 / 62 unverified), the verification method and timeline, and a commitment to supplement. Filing a complete-looking report late is worse than filing an accurate incomplete one on time. - **Supplemental reports** to both bodies as each tranche of the 62 is resolved, and immediately if the number of affected subjects, the number of affected sites, or the adverse-event picture changes materially. - The nerve-weakness event was already routed through the ordinary safety channel; file a **corrected/supplemental safety notification** noting that the event occurred in a subject consented on a form that omitted that very risk, and assess whether that combination is separately reportable as an unanticipated problem or reportable device effect under the approved plan. Do not let the consent report and the safety report tell inconsistent stories. - Confirm whether the conversion error touched **other documents, other language versions, or other NovaCrest protocols** using the same template/tool; if so, expand both reports. --- ## PART 4 — EMERGENCY BOARD REVIEW (Thursday) **Submission package (delivered tonight):** 1. Chronology: when 4.2 was created, approved, distributed, used; when and how the omission was found; who knew what when. 2. Redline of 4.1 → 4.2 → 4.3 showing the missing paragraph; root-cause statement on the conversion error. 3. Affected-population table: 38 confirmed 4.2; 20 confirmed 4.1/4.3; 62 unverified; 12 pending implants (4 confirmed 4.2, 8 unverified); 6 safety visits. 4. The nerve-weakness case narrative. 5. Holds already imposed and the care-continuation plan. 6. Proposed corrected consent (issue as **version 4.4** — a new, dated, board-approved document rather than reuse of 4.3, so the record shows a corrective action; 4.4 restores the 3% nerve-weakness paragraph and adds a plain-language statement that an earlier form omitted it). 7. Proposed **re-consent script and process** for subjects awaiting intervention. 8. Proposed **notification letter and data-use election form** for subjects who completed intervention. 9. Scope-verification protocol and completion date. 10. Data-handling proposal, submitted as a question for the board, not a decision already made. 11. Preservation statement, including disclosure of the proposed PDF replacement and its refusal. **Specific approvals requested:** (a) corrected consent 4.4; (b) re-consent process, script, and who may obtain it; (c) notification letter and election form for completed subjects, plus timing; (d) whether re-consent/authorization is required or optional for continued use of already-collected data; (e) conditions for lifting the enrollment hold, site by site; (f) whether additional medical evaluation should be offered to 4.2 subjects; (g) any board-directed disclosures to local site IRBs; (h) whether the 20 confirmed 4.1/4.3 subjects may proceed to intervention once their document is physically verified. --- ## PART 5 — RE-CONSENT OF SUBJECTS AWAITING INTERVENTION Applies to the 4 confirmed 4.2 subjects, the 8 unknown-version subjects, and any additional not-yet-completed subjects identified in scope work. 1. Only after board approval of 4.4 may re-consent occur; only after re-consent may the postponed intervention be rescheduled. 2. Re-consent all 12 on 4.4 regardless of the version each originally signed. This is permissible and prudent; verify each original version anyway for the record and the reports. 3. Process: in-person or documented live discussion with a qualified investigator; explicit statement that the earlier form omitted the 3% temporary-nerve-weakness risk; description of the risk, typical course and resolution, monitoring, and treatment; a genuine opportunity to decline; adequate time to consider; no scheduling pressure. 4. **Signature and date must be the actual current date.** No backdating, no "re-execution as of" the original date, no replacing the original signed form (Rule 6). The original 4.2 signature stays in the file; the 4.4 signature is added, with a re-consent note explaining why. 5. Log for each subject: original version, verification source, date/time of re-consent discussion, person obtaining it, outcome. 6. If a subject declines: no research intervention; withdraw from interventional participation with no penalty; ensure transition to appropriate clinical care and document the referral; capture the subject's wishes on data use and continued safety follow-up. 7. Reschedule implants only when all three conditions are met: board-approved 4.4 in hand, that subject's version verified, and 4.4 re-consent signed. --- ## PART 6 — SUBJECTS WHO COMPLETED INTERVENTION Applies to the 38 confirmed 4.2 subjects and any 4.2 subjects found among the 62. 1. **Timing:** begin within 24–48 hours of board approval of the letter; complete outreach to confirmed 4.2 subjects within 5 business days; document three contact attempts by two modalities before treating a subject as unreachable, then send certified mail. 2. **Method:** documented live conversation (call or visit) plus written notice. Email alone is inadequate. 3. **Content:** the risk that was omitted and its 3% incidence; a plain statement that the form they signed did not include it and why; symptoms to watch for; what to do and whom to call; what monitoring or evaluation is being offered; that participation and data use are their choice; that care and safety follow-up continue regardless; the board's and regulator's involvement; contact information for the site, the sponsor, and the board. 4. **Choices to offer:** (i) continue safety follow-up or not; (ii) permit continued use of data already collected, or object; (iii) permit or refuse future data collection; (iv) accept an offered clinical/neurologic evaluation. 5. Document each election on the board-approved form with the current date. Again: **no backdating and no recreation of a "valid" earlier consent.** 6. The subject who experienced nerve weakness gets first-priority, individualized contact (see Part 8). --- ## PART 7 — PREVIOUSLY COLLECTED DATA 1. **Nothing is deleted, purged, or excluded unilaterally** (Rules 7, 8). 2. Flag affected records in the EDC with a metadata tag ("consent version 4.2 — under board review") that is additive and does not alter or hide the underlying data; do not lock investigators out of safety data. 3. **Continue collecting safety data** on all implanted subjects; safety monitoring is not contingent on the data-use question. 4. Segregate 4.2-derived data from interim efficacy analyses and any regulatory submission until the board rules; notify any DSMB/statistician of the flag and of the pause. 5. Present the board the four statutory considerations — risk to subjects, subject wishes, scientific integrity, and the nature of the noncompliance (an unintended conversion error, promptly self-identified and self-reported, with the risk itself accurately described in the protocol and in 4.1/4.3) — and follow its determination. 6. Where a subject objects to continued use, honor the objection prospectively as the board directs; record the objection; do not destroy the record itself absent board direction and a documented retention analysis. 7. Disclose the consent defect and the board's data determination in any future submission, publication, or clinical-report-form documentation. No silent use. --- ## PART 8 — THE KNOWN NERVE-WEAKNESS EVENT 1. Treat as the highest-priority individual matter. PI-led personal contact within 24 hours: current neurologic status, offer of expedited specialist evaluation at sponsor expense, full explanation that the risk was known, was in the protocol, and was omitted from the form the subject signed. 2. Do not characterize the event as "expected and disclosed." It was expected under the protocol and **not** disclosed to this subject. Say so plainly, to the subject and in both reports. 3. Confirm the original safety report's accuracy and file a supplement linking event to consent defect; assess separate unanticipated-problem/reportable-event obligations. 4. Offer the subject the full set of Part 6 choices, plus a specific choice about continued use of that subject's data. 5. Route any compensation, complaint, or claim discussion through counsel; keep it strictly separate from — and never a condition of — care, follow-up, or the subject's data-use choice. No release may be sought as a condition of medical evaluation. 6. Use the case in the board submission as the concrete illustration of why post-hoc email notification is unacceptable. --- ## PART 9 — SCOPE DETERMINATION FOR THE 62 UNVERIFIED SUBJECTS **Governing principle:** determine, do not presume. No "probably all 4.2" and no "probably fine" (Rule 9). Two independent lines must converge on each subject: (1) version-controlled documentary evidence, and (2) direct site confirmation. **Documents to pull:** - Consent version master log: creation, board approval, effective, superseded, and withdrawal dates for 4.1, 4.2, 4.3; distribution emails and acknowledgments per site. - The conversion-tool/document-management logs establishing when the paragraph was lost and which file was released — this fixes the outer date boundaries of 4.2's availability. - **Wet-ink original signed forms in each site's regulatory binder** — the controlling evidence; version and revision date appear on the form footer/header. - Scanned/uploaded signed PDFs plus EDC/eTMF **upload timestamps, metadata, and audit trails**; identify every missing upload by subject ID. - Site consent logs, screening and enrollment logs, delegation-of-authority logs, visit source notes recording consent version and time. - Site printing/photocopy and stock records; whether obsolete 4.2 stock remained in circulation after 4.3 issued. - Monitoring visit reports and prior consent-verification findings. - IRB approval letters per version per site. **Direct site confirmation:** - Written PI attestation, **subject by subject**, naming the version signed and citing the specific source document, with the signed form attached. No aggregate or "all our subjects used 4.3" attestations. - Sponsor monitor performs 100% on-site source verification of consent version against the wet-ink original at all five sites; monitors, not site staff, complete the reconciliation sheet. - Missing PDF uploads completed within 48 hours; missing wet-ink originals escalated immediately as a separate documentation deficiency and reported as such. **Three-bucket output, updated daily:** Confirmed 4.2 / Confirmed 4.1 or 4.3 / **Unresolved**. Unresolved subjects remain under the intervention hold and are counted as unresolved in every report until documentary and attestation evidence agree. If a subject's version can never be established, report that fact and treat the subject as affected for notification and re-consent purposes, with the reasoning disclosed to the board. **Discrepancy rule:** any conflict between the database, the attestation, and the wet-ink original is escalated to the sponsor QA lead, resolved against the original document, and logged. --- ## PART 10 — PRESERVATION AND PRIVILEGE ARCHITECTURE 1. **Two workstreams, deliberately separated:** - **Operational fact-finding** (QA, Clinical Ops, Regulatory, monitors): version reconciliation, subject-level confirmations, chronology, root cause, notification and re-consent execution, the board and regulator reports. **Not privileged; fully disclosable; must be candid and complete.** - **Privileged legal analysis** (counsel-directed): liability exposure, claims and indemnity, personnel consequences, litigation strategy, the CSO instruction as a compliance matter. Separate files, separate distribution, clear labeling. 2. **Privilege does not gate reporting or candor** (Rule 10). Do not route the factual chronology through counsel to shield it, do not label operational records "privileged," and do not withhold consent documents, logs, timestamps, or subject counts from the board or regulator on privilege grounds. Any assertion of privilege over factual material is presumptively wrong here. 3. Avoid mixed-content memos. Instruct fact-finders in writing to record facts without legal conclusions or speculation about culpability. 4. Give brief Upjohn-style advisories to interviewees; instruct all staff that no one may alter, withhold, or "tidy" a record and that questions from monitors, the board, or the regulator must be answered truthfully. 5. Log the CSO's replacement request, counsel's refusal, and the technical lockdown. Consider restricting the CSO's database access, and address the request through the compliance/HR process — separately from the operational response. Disclose the request to the board and the regulator as part of the factual record; a documented refusal is a mitigating fact, a concealed request is an aggravating one. --- ## PART 11 — SEQUENCED TIMELINE ### Wednesday (Day 0) | Time | Action | |---|---| | 10:00–11:00 | Incident lead named; written study-wide enrollment hold and nonurgent-intervention hold issued to all five sites; 12 implants cancelled; telephone confirmation from each PI | | 10:00–11:00 | PDF replacement refused in writing; document/litigation hold issued; repository permissions locked; forensic snapshot taken; audit-log query launched | | 11:00–13:00 | Emergency board session confirmed for Thursday; chronology opened; sites directed to check for faster local reporting duties | | 13:00–17:00 | PI outreach calls to all 12 postponed-implant subjects; safety-visit plan confirmed for the 6 subjects; 24/7 medical monitor line live | | 13:00–17:00 | PI-led contact with the nerve-weakness subject; specialist evaluation offered | | 15:00–17:00 | Version 4.4 drafted; re-consent script, notification letter, and data-use election form drafted | | Evening | Board submission package delivered; regulator report drafting begins in parallel; scope-verification protocol issued to monitors | ### Thursday (Day 1) - Emergency board review; obtain approval of 4.4, re-consent process, notification letter, and interim data direction; obtain conditions for resuming enrollment. - **File the ethics-board noncompliance report** (well inside the 5-business-day period), with confirmed/unknown breakdown and supplement commitment. - Monitors on site at all five sites; 100% consent source verification begins; missing-PDF upload orders issued with a 48-hour deadline. - Supplemental safety notification on the nerve-weakness event prepared. - Site staff retrained on the hold, 4.4, and the no-alteration directive. ### Friday (Day 2) - **File the device-regulator report** (target; hard cutoff Monday, outer limit the following Tuesday/Wednesday). - Begin re-consent discussions on approved 4.4 with the 12 postponed subjects. - Begin outreach to the 38 confirmed 4.2 completed subjects (live call + approved letter + election form). - First daily three-bucket scope report issued. - Root-cause analysis on the conversion error; check other documents, translations, and protocols using the same template. ### Weekend (Days 3–4) - Safety visits and clinical care continue as scheduled; enhanced neurologic surveillance calls to 4.2 subjects. - Monitor reconciliation continues; missing wet-ink originals escalated. - Completed-subject outreach continues. ### Monday (Day 5) - Regulator report filed if not already (absolute internal cutoff). - First implants may be rescheduled — **only** for subjects who are version-verified and 4.4-re-consented. - Interim scope update to board and regulator: bucket counts, unresolved subjects, method used. ### Tuesday–Wednesday (Days 6–7) - Target completion of subject-level version determination for the 62; every remaining unresolved subject individually identified, explained, and kept under hold and treated as affected for notification purposes. - Completed-subject outreach for confirmed 4.2 subjects finished; election forms filed; unreachable subjects escalated to certified mail. - Supplemental reports to board and regulator with final/near-final scope, data-use recommendation, CAPA (document-conversion QC, mandatory version-footer verification at consent, upload-within-24-hours requirement, consent-version field made mandatory in the EDC, periodic consent-version reconciliation). - Site-by-site enrollment resumption requested only where the board's conditions are met and document control is verified; enrollment stays closed anywhere it is not. - Board decision on continued use of previously collected data obtained and implemented; disclosure language for future submissions and publications drafted. --- ## PART 12 — NON-NEGOTIABLES 1. No implant on a defective or unverified consent, whatever the schedule pressure. 2. No post-hoc email in place of pre-intervention re-consent. 3. No file replacement, deletion, or "cleaning" — ever, and the request itself gets disclosed. 4. No backdated or recreated consent. 5. No delay in reporting to await a complete scope picture. 6. No assumption that the 62 are all affected or all clear. 7. No care withheld or safety visit cancelled to hold the pause. 8. No privilege claim over facts owed to the board or the regulator.