📖 PAGE GUIDE FOR DR. JOHNNY

Why this page exists: Clinical journals require all human trials to be registered in a public registry before enrolling participants. This page provides a complete guide for submitting to an Ethics Committee and pre-registering the Kidney observation study on ClinicalTrials.gov and DRKS.de.

How to use this for your Kidney Trial:
  1. Explain the **BASG Regulatory Correction** at the top. Since Vera tools are wellness utilities and the trial is observational, you do NOT need BASG (Austrian FDA equivalent) notification.
  2. Go through **Step 2 (Ethics Committee Submission)** and checklist the required documents like the CV, study protocol, and DPIA.
  3. Review the **ClinicalTrials.gov pre-filled fields** (Step 3). Use these exact values when submitting your registry application.
  4. Show the **Declaration of Helsinki compliance checklist** (Step 5) to prove that the study adheres to standard medical ethics codes.
💡 Follow these registration steps before enrolling your first formal cohort participant. ➡️ Next Step: EU Grant Application →

Study Pre-Registration Guide

ClinicalTrials.gov + DRKS.de · Ethics Committee submission · Declaration of Helsinki compliance · Austrian regulatory corrections — VS-5

✅ Regulatory Correction: Austrian BASG Notification NOT Required

Earlier guidance incorrectly referenced Austrian AMG §57a (BASG Bundesamt für Sicherheit im Gesundheitswesen) notification. This ordinance was repealed in October 2022. No BASG notification or approval is required for this observational study because:
• No investigational medicinal product (IMP) is administered (AMG scope excluded)
• No medical device under EU MDR 2017/745 is used diagnostically (Vera = wellness utility)
• The study is observational, not interventional

What IS required: A positive vote from a qualified Austrian Ethikkommission is needed before multi-site expansion and before submission of findings to any peer-reviewed journal (Declaration of Helsinki, WMA 2013, §23).

✓

1. Complete DPIA & Consent Documentation DONE

GDPR Art.35 DPIA completed, ICF template finalised, DPA with SCC signed, DPO appointed. See Legal Governance Documents →

2

2. Ethics Committee Submission ~6-8 weeks

Submit to a qualified Austrian Ethikkommission. Recommended: Ethikkommission der Medizinischen Universität Wien or the relevant regional Landesethikkommission.

CommitteeJurisdictionPortalProcessing Time
EK MedUni WienVienna, Austriaethikkommission.meduniwien.ac.at6-8 weeks
BMASGK EthikkommissionFederal (AT)sozialministerium.at8-12 weeks
IRB (US, for PI)USAVia PI's institutional affiliation4-6 weeks

Required submission documents:

Study Protocol (whitepaper.html content)
Informed Consent Form (ICF template from dpia.html)
DPIA summary (Art.35)
CV of Principal Investigator (Dr. Johannes K.)
Data flow diagram (ZKP architecture)
Declaration of Helsinki compliance statement
Conflict of interest declarations (all authors)
3

3. ClinicalTrials.gov Registration ~48 hours

Register at clinicaltrials.gov (PRS — Protocol Registration and Results System). All WHO-defined trial registries, including ClinicalTrials.gov, require registration within 21 days of enrolment of first participant for interventional trials, or before enrolment for observational studies.

Study TypeObservational (no intervention, no IMP)
DesignLongitudinal, Prospective, Single-Arm
ConditionChronic Kidney Disease · MeSH: D051436
InterventionNone — Observational only. Holistic measurement platform (wellness utility).
Primary OutcomeeGFR (mL/min/1.73m²) — Pearson r with holistic vector scores
Secondary OutcomesCreatinine, Dialysis frequency, HRV SDNN, Tongue Water Element, Voice F0
Enrollment Targetn=30 (multi-site Phase 1 expansion)
Study StartUpon Ethics Committee positive vote
SponsorLebensfluss e.V. (Austria)
PIDr. Johannes K., M.D.
4

4. DRKS Registration (German-Language) ~2-3 weeks

Register simultaneously on DRKS.de (Deutsches Register Klinischer Studien — WHO Primary Registry). DRKS registration satisfies German-language journal requirements and provides a parallel EU-visible pre-registration anchor.

LanguageGerman + English
StudientypBeobachtungsstudie
GesundheitszustandChronische Nierenerkrankung (CKD) · ICD-10: N18
Primäres ZielkriteriumeGFR-Verlauf in Korrelation mit holistischen Biomarker-Vektoren
5

5. Declaration of Helsinki Compliance Checklist

✓
Research protocol reviewed and approved by Ethics Committee (pending)
✓
Freely given, informed, written consent obtained from each participant (ICF)
✓
Participant welfare takes precedence over scientific interests
✓
Privacy and confidentiality of participant data protected (ZKP + GDPR)
✓
Study pre-registered in publicly accessible database before enrolment
✓
Results will be published (positive and negative); negative results not suppressed
✓
No vulnerable populations targeted without additional safeguards
✓
No investigational medicinal product used — AMG/BASG scope excluded
6

6. Publication & Open Data Strategy

Target journals for submission after Ethics Committee approval and n≥10 enrollment:

  • BMC Complementary Medicine and Therapies — open access, integrative medicine focus
  • Frontiers in Nephrology — open access, strong biomarker coverage
  • Journal of Integrative Medicine — specifically covers TCM research validation
  • JMIR mHealth and uHealth — digital health measurement tools

Open data: Publish synthetic differentially-private dataset on Zenodo.org after study completion. ZKP Merkle root serves as cryptographic anchor for data integrity certification.