Research Dashboard
DK Technologies · ABENA IHR · IRB Ref: DK-2025-IHR · GCP Compliant
Active Studies
0
All designs
Enrolled Participants
0
Consented & active
Genomic Profiles
0
Full + partial
Open AEs
0
Graded & unresolved
Data Points
0
CRF + genomic
Active Studies
| Study ID | Title | Design | Genomic | N | Status |
|---|---|---|---|---|---|
| No studies yet · Click + New Study | |||||
Recent Audit Events
No audit events yet.
System Compliance Status
21 CFR Part 11 Audit Trail Active
Blockchain Data Attestation Live
HIPAA De-identification Engine Ready
CDISC SDTM/ADaM Export Available
HL7 FHIR R4 Integration Active
GA4GH Genomic Standards Enabled
eSignature Module — Pending Config
Genomic Standards Supported
VCF 4.2 HGVS Nomenclature GRCh38/hg38
GRCh37/hg19 CDISC GF Domain PharmGKB
CPIC Guidelines ClinVar dbSNP rs IDs
OMIM GA4GH Standards GTEx
GRCh37/hg19 CDISC GF Domain PharmGKB
CPIC Guidelines ClinVar dbSNP rs IDs
OMIM GA4GH Standards GTEx
All Studies
Complete study registry · Any design type · FDA/IRB grade
| Study ID | Title / PI | Design | Genomic | Phase | Enrolled / Target | IRB | Status | Action |
|---|---|---|---|---|---|---|---|---|
| No studies registered yet. | ||||||||
Participant Enrollment
ICH E6(R2) GCP compliant · Consent verification · Genomic consent tracking
Enrollment Status by Study
No active studies yet.
Enrollment Stats
0
Total Enrolled
0
Genomic Consent
0
Active
0
Screening
Enrolled Participants
| Subject ID | Study | Arm | Age/Sex | Enrolled | Genomic Data | Visits Complete | Status | Action |
|---|---|---|---|---|---|---|---|---|
| No participants enrolled yet. | ||||||||
Participant Data
Full participant profiles · Clinical + genomic + eCBome data
⬡ Select a participant from the Enrollment section or click a row in any study table to view their full profile.
Genomic Data Center
Gene definitions · SNP input · Variant annotation · Study-specific genomic config
ℹ Researchers define genes, SNPs, and variants at the study level. Each participant can then have genomic data entered against those definitions. Supports targeted panels, WES, WGS, SNP arrays, and pharmacogenomic profiling.
Gene Targets
SNP Registry
Variant Library
Chromosome Map
Study Gene Targets
Define gene targets per study to enable participant-level genomic data entry.
eCBome Gene Presets
🧬 Full eCBome Panel
💊 PGx CYP Panel
🧠 Neuroinflammation
⚗ Detox / Methylation
🔥 Inflammatory Pathway
🔴 Oncology Panel
Chromosome Overview
Purple = genes with data assigned
Reference Genome
● Active GRCh38 / hg38 (Dec 2013)
Supported GRCh37 / hg19 (Feb 2009)
HGVS v20.05 nomenclature
ClinVar integration ready
dbSNP Build 156
ClinVar integration ready
dbSNP Build 156
SNP Registry — All Studies
| rs ID | Gene | Chr | Position (GRCh38) | Ref | Alt | Type | Clinical Significance | Study | N Genotyped |
|---|---|---|---|---|---|---|---|---|---|
| No SNPs registered. Add per study or use gene presets. | |||||||||
Pharmacogenomics
CPIC guidelines · PharmGKB · CYP enzyme phenotyping · PGx therapeutic implications
ℹ ABENA integrates CPIC (Clinical Pharmacogenomics Implementation Consortium) guidelines. PGx results are automatically linked to therapeutic recommendations, including cannabinoid metabolism profiles.
Key PGx Genes — eCBome Relevance
| Gene | Function | eCBome Relevance | CPIC Level |
|---|---|---|---|
| CYP2C9 | THC, CBD metabolism | Poor metabolizers: ↑ cannabinoid exposure | A |
| CYP3A4 | CBD oxidation | Inducers reduce CBD efficacy | A |
| CYP2C19 | CBD, clobazam | Ultra-rapid: reduced CBD levels | A |
| FAAH | AEA hydrolysis | rs324420 C385A: ↑ AEA tone, anxiolytic | B |
| MGLL | 2-AG hydrolysis | Variants alter 2-AG levels / CB1 signaling | B |
| CNR1 | CB1 receptor | rs1049353: expression, psychiatric risk | B |
| COMT | Catechol-O-methyltransferase | Val158Met: pain, stress, cannabinoid interaction | A |
| OPRM1 | Opioid receptor | A118G: pain sensitivity, opioid-CB crosstalk | A |
| MTHFR | Folate/methylation | C677T: detox capacity, eCBome lipid substrate | B |
PGx Participant Phenotype Summary
Enter participant genomic data to generate PGx phenotype assignments.
Variant Library
HGVS notation · ClinVar linkage · Study-specific variant definitions
| HGVS (cDNA) | HGVS (protein) | Gene | Variant Type | ClinVar | Zygosity (study) | Functional Impact | Source |
|---|---|---|---|---|---|---|---|
| No variants defined. Add per study or import from VCF. | |||||||
CRF Data Entry
CDISC CDASH compliant · Per-participant, per-visit data capture · Real-time validation
⬡ Select a study and participant above to begin data entry.
eCBome + Laboratory Data
Endocannabinoid biomarkers · Toxin panel · Standard labs · ABENA analysis pipeline
eCBome Panel
| Analyte | Value | Unit | Reference | Flag | Date |
|---|---|---|---|---|---|
| No eCBome data entered. | |||||
Toxin Panel
| Analyte | Value | Unit | Burden Level | Date |
|---|---|---|---|---|
| No toxin data entered. | ||||
Adverse Events
CTCAE v5.0 grading · MedWatch ready · SAE escalation · DSMB reporting
Total AEs
0
SAEs
0
Resolved
0
| Subject ID | Study | AE Term (MedDRA) | Grade (CTCAE) | SAE | Onset | Outcome | Causality | Reported By | Status |
|---|---|---|---|---|---|---|---|---|---|
| No adverse events reported. | |||||||||
Statistical Analysis
SAP-driven · Pre-specified analyses · ANCOVA, mixed models, survival, non-parametric
⬡ Select a study and click Run Analysis to generate pre-specified statistical outputs aligned with your SAP.
Available Analysis Types
Confirmatory
▸ Primary endpoint analysis (ITT + PP)
▸ Key secondary endpoints
▸ Subgroup analyses (pre-specified)
▸ Multiplicity adjustment (Bonferroni, BH)
▸ Key secondary endpoints
▸ Subgroup analyses (pre-specified)
▸ Multiplicity adjustment (Bonferroni, BH)
Descriptive
▸ Baseline demographics (Table 1)
▸ Exposure summary
▸ Safety summary
▸ Disposition (CONSORT flow)
▸ Exposure summary
▸ Safety summary
▸ Disposition (CONSORT flow)
Survival & Longitudinal
▸ Kaplan-Meier curves
▸ Cox proportional hazards
▸ Mixed models for repeated measures (MMRM)
▸ GEE for correlated data
▸ Cox proportional hazards
▸ Mixed models for repeated measures (MMRM)
▸ GEE for correlated data
Genomic Integration
▸ Genotype-phenotype association
▸ Hardy-Weinberg Equilibrium test
▸ Allele/genotype frequency tables
▸ PGx subgroup analysis
▸ Gene × treatment interaction
▸ Hardy-Weinberg Equilibrium test
▸ Allele/genotype frequency tables
▸ PGx subgroup analysis
▸ Gene × treatment interaction
Genomic Analysis
HWE · Allele frequencies · Association tests · PGx phenotype distribution · Gene × outcome
⬡ Requires at least 5 participants with genomic data. Select study and run analysis.
Genomic Analysis Methods
Association Testing
▸ Chi-square / Fisher's exact (genotype × outcome)
▸ Cochran-Armitage trend test
▸ Logistic regression (additive/dominant/recessive)
▸ Linear regression for quantitative traits
▸ Gene × environment interaction
▸ Chi-square / Fisher's exact (genotype × outcome)
▸ Cochran-Armitage trend test
▸ Logistic regression (additive/dominant/recessive)
▸ Linear regression for quantitative traits
▸ Gene × environment interaction
Quality & Reporting
▸ Hardy-Weinberg Equilibrium (HWE) test
▸ Allele & genotype frequency tables
▸ Linkage disequilibrium (LD) analysis
▸ Population stratification checks
▸ CDISC GF domain output for FDA submission
▸ Hardy-Weinberg Equilibrium (HWE) test
▸ Allele & genotype frequency tables
▸ Linkage disequilibrium (LD) analysis
▸ Population stratification checks
▸ CDISC GF domain output for FDA submission
IRB Tracker
Submission management · Amendment tracking · Annual renewals · Approval certificates
⬡ Create a study to begin IRB tracking. Each study gets a dedicated IRB workflow.
21 CFR Part 11 Compliance
Electronic records · Electronic signatures · Access controls · Audit trail · Data integrity
✓ ABENA Research Platform operates in full 21 CFR Part 11 compliance mode. All records are time-stamped, user-attributed, and blockchain-attested.
§11.10 Controls for Closed Systems
§11.10(a) Validation of systems
Active
§11.10(b) Ability to generate accurate copies
Active
§11.10(c) Record protection / archival
Blockchain
§11.10(d) Limiting access to authorized users
Active
§11.10(e) Audit trail — secure, computer-generated
Active
§11.10(f) Operational system checks
Active
§11.10(g) Authority checks
Active
§11.10(i) Determination of record validity
Config needed
§11.50 Signature Manifestations
Printed name of signer
Config needed
Date/time of signature
Config needed
Blockchain timestamp attestation
Active
Blockchain Data Integrity
Every record write generates:
▸ SHA-256 content hash
▸ On-chain block attestation (Substrate)
▸ Post-quantum cryptographic signature
▸ Immutable timestamped audit entry
Node: testnet.abenaihr.com
▸ SHA-256 content hash
▸ On-chain block attestation (Substrate)
▸ Post-quantum cryptographic signature
▸ Immutable timestamped audit entry
Node: testnet.abenaihr.com
Audit Trail
Immutable · Time-stamped · User-attributed · Blockchain-attested · 21 CFR §11.10(e)
TIMESTAMP (UTC)USERACTION / DETAILBLOCK HASH
No audit events yet. System actions will appear here.
Protocol Deviations
ICH E6(R2) required · Classification · CAPA tracking · IRB reportable assessment
| Dev ID | Subject | Study | Type | Description | IRB Reportable | CAPA Status | Logged |
|---|---|---|---|---|---|---|---|
| No protocol deviations recorded. | |||||||
Reports
ICH / FDA / IRB compliant output · Auto-generated from live data
FDA Submission Reports
Clinical Study Report (CSR)
ICH E3 format
IND Safety Report
21 CFR 312.32
NDA Module 5 Package
eCTD format
CONSORT Flow Diagram
Participant disposition
Genomic Analysis Report
CDISC GF + FDA guidance
PGx Companion Report
CPIC / PharmGKB
IRB / Regulatory Reports
IRB Annual Renewal
Continuing review
Protocol Amendment
IRB submission ready
SAE Summary Report
MedWatch / CIOMS
DSMB Report Package
Interim safety data
Protocol Deviation Report
IRB reportable deviations
21 CFR Part 11 Audit Report
Electronic records log
Export Center
CDISC SDTM · ADaM · FHIR R4 · REDCap · VCF · FDA eCTD · Blockchain-attested
ℹ All exports are HIPAA de-identified by default. Each dataset carries an on-chain blockchain provenance hash. Select study, configure options, and export.
Clinical Data Formats
CDISC SDTM
FDA submission
CDISC ADaM
Analysis datasets
REDCap XML
Import/export
De-ID CSV
De-identified flat file
FHIR R4 Bundle
HL7 standard
CDISC ODM-XML
Metadata + data
Genomic Data Formats
VCF 4.2
Variant call format
CDISC GF Domain
Genomic findings
PGx Summary
CPIC phenotypes
HWE + Freq Tables
Population genetics
GA4GH JSON
Federated sharing
Blockchain Attestation
Provenance package