SYNTHETIC DEMO DATA — no real patient information

AIAIIA Clinical TrialsAll India Institute of Ayurveda · NPvCC

Audit & access

An append-only record of everything that happened, built to the ALCOA+ data integrity principles. Nothing on this page can be edited or deleted — there are no controls to do so, by design.

ALCOA+ compliant — append only236 entries retained

Immutable audit trail

Timestamped to the second in ISO 8601 with a fixed IST offset. Old and new values are both retained; a reason-for-change is captured on any modification to entered data.

EntryTimestamp (IST)UserRoleActionEntityOld valueNew valueReason for changeIP
AUD-002362026-09-07T19:50:05+05:30P. DaspdasStudy CoordinatorUPDATEObservation.valueQuantityAIIA-ONC-DEL-004 / SYSBP135 mm[Hg]131 mm[Hg]Source data verification — transcription corrected10.9.1.22
AUD-002352026-09-07T19:25:52+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorUPDATEStudy.statusCTRI/2026/XX/SYN006approvedactiveEntry error identified during medical review10.9.1.5
AUD-002342026-09-07T18:17:09+05:30IEC Secretariatiec.secretariatEthics CommitteeAPPROVEProtocolAIIA/IEC/2026/161Under reviewApproved—10.12.4.19
AUD-002332026-09-07T16:56:51+05:30S. VenkatesansvenkatesanPrincipal InvestigatorUPDATEStudy.statusCTRI/2026/XX/SYN010approvedactiveMonitor finding, CAPA reference MON-2026-01410.9.1.22
AUD-002322026-09-07T16:56:22+05:30R. MehrotrarmehrotraStudy CoordinatorUPDATESubject.visitAIIA-YAK-CHE-001Visit 4 — not doneVisit 4 — completedSource data verification — transcription corrected10.12.7.8
AUD-002312026-09-07T15:35:48+05:30A. SharmaasharmaData ManagerRAISEDataQueryQ-1088—Query raised on AIIA-SAN-JAI-023—10.12.7.8
AUD-002302026-09-07T14:46:29+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorSIGNeCRFAIIA-AMV-JAM-005UnsignedElectronically signed—10.44.2.17
AUD-002292026-09-07T14:23:11+05:30S. VenkatesansvenkatesanPrincipal InvestigatorCREATEAdverseEventAE-030—Dizziness · AESER=N—10.9.1.22
AUD-002282026-09-07T13:25:44+05:30Director's Officedirector.officeInstitutional LeadershipUPDATEStudy.statusCTRI/2026/XX/SYN004approvedactiveData clarification form received10.9.1.22
AUD-002272026-09-07T12:53:10+05:30S. VenkatesansvenkatesanPrincipal InvestigatorSIGNeCRFAIIA-GRH-DEL-011UnsignedElectronically signed—10.12.4.19
AUD-002262026-09-07T12:30:26+05:30Director's Officedirector.officeInstitutional LeadershipUPDATEStudy.statusCTRI/2026/XX/SYN012approvedactiveProtocol amendment v2.1 — re-consent captured10.44.2.17
AUD-002252026-09-07T12:21:49+05:30R. MehrotrarmehrotraStudy CoordinatorUPDATESubject.visitAIIA-AMV-JAM-003Visit 3 — not doneVisit 3 — completedProtocol amendment v2.1 — re-consent captured10.9.1.22
AUD-002242026-09-07T11:41:51+05:30R. MehrotrarmehrotraStudy CoordinatorCREATEAdverseEventAE-018—Constipation · AESER=N—10.12.4.31
AUD-002232026-09-07T11:33:49+05:30A. SharmaasharmaData ManagerRAISEDataQueryQ-2705—Query raised on AIIA-SAN-DEL-032—10.12.4.31
AUD-002222026-09-07T11:17:26+05:30Director's Officedirector.officeInstitutional LeadershipVIEWAuditTrailaudit—Audit trail inspected—10.12.7.8
AUD-002212026-09-07T11:00:33+05:30NPvCC Duty Officernpvcc.officerPharmacovigilance OfficerSUBMITSAE initial reportSAE-004PendingTransmitted to Sponsor, EC, CDSCO—10.44.2.41
AUD-002202026-09-07T10:22:12+05:30A. SharmaasharmaData ManagerRAISEDataQueryQ-9871—Query raised on AIIA-ONC-DEL-003—10.44.2.41
AUD-002192026-09-07T09:23:44+05:30S. VenkatesansvenkatesanPrincipal InvestigatorVIEWStudyCTRI/2026/XX/SYN003—Record opened—10.44.2.17
AUD-002182026-09-07T09:04:46+05:30A. SharmaasharmaData ManagerRAISEDataQueryQ-6704—Query raised on AIIA-KIT-DEL-004—10.9.1.5
AUD-002172026-09-07T08:23:39+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorSIGNeCRFAIIA-KIT-KOL-010UnsignedElectronically signed—10.9.1.5
AUD-002162026-09-06T19:45:42+05:30A. SharmaasharmaData ManagerRAISEDataQueryQ-2639—Query raised on AIIA-KIT-DEL-004—10.12.4.31
AUD-002152026-09-06T18:19:10+05:30S. VenkatesansvenkatesanPrincipal InvestigatorSIGNeCRFAIIA-MAD-JAI-008UnsignedElectronically signed—10.44.2.41
AUD-002142026-09-06T17:53:21+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorLOGINSessionsession—Authenticated (MFA)—10.12.4.31
AUD-002132026-09-06T16:18:58+05:30A. SharmaasharmaData ManagerUPDATEObservation.valueQuantityAIIA-CHT-DEL-003 / SYSBP145 mm[Hg]144 mm[Hg]Data clarification form received10.9.1.22
AUD-002122026-09-06T14:58:28+05:30CDSCO Inspectorcdsco.inspectorRegulator (read-only)LOGINSessionsession—Authenticated (MFA)—10.12.4.31
AUD-002112026-09-06T11:07:49+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorVIEWStudyCTRI/2026/XX/SYN009—Record opened—10.44.2.41
AUD-002102026-09-05T19:23:44+05:30A. SharmaasharmaData ManagerRAISEDataQueryQ-3010—Query raised on AIIA-ARD-DEL-002—10.9.1.5
AUD-002092026-09-05T19:10:11+05:30A. SharmaasharmaData ManagerRAISEDataQueryQ-7029—Query raised on AIIA-MAD-JAI-003—10.9.1.22
AUD-002082026-09-05T16:40:14+05:30S. VenkatesansvenkatesanPrincipal InvestigatorUPDATESubject.visitAIIA-SAN-JAI-035Visit 6 — not doneVisit 6 — completedQuery response from site10.12.4.19
AUD-002072026-09-05T15:27:36+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorSIGNeCRFAIIA-GRH-DEL-005UnsignedElectronically signed—10.12.4.19
AUD-002062026-09-05T13:13:39+05:30R. MehrotrarmehrotraStudy CoordinatorUPDATESubject.visitAIIA-YAK-DEL-002Visit 2 — not doneVisit 2 — completedProtocol amendment v2.1 — re-consent captured10.44.2.41
AUD-002052026-09-05T13:01:01+05:30A. SharmaasharmaData ManagerEXPORTSDTM datasetDM.xpt—Export preview generated (DM domain)—10.12.4.31
AUD-002042026-09-04T14:18:22+05:30A. SharmaasharmaData ManagerUPDATEObservation.valueQuantityAIIA-KIT-KOL-010 / SYSBP125 mm[Hg]133 mm[Hg]Monitor finding, CAPA reference MON-2026-01410.12.4.31
AUD-002032026-09-04T12:36:28+05:30Director's Officedirector.officeInstitutional LeadershipUPDATEStudy.statusCTRI/2026/XX/SYN004approvedactiveEntry error identified during medical review10.9.1.22
AUD-002022026-09-04T10:10:16+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorSIGNeCRFAIIA-SAN-DEL-018UnsignedElectronically signed—10.44.2.17
AUD-002012026-09-04T09:17:47+05:30IEC Secretariatiec.secretariatEthics CommitteeAPPROVEProtocolAIIA/IEC/2026/143Under reviewApproved—10.9.1.5
AUD-002002026-09-03T19:06:17+05:30R. MehrotrarmehrotraStudy CoordinatorLOGINSessionsession—Authenticated (MFA)—10.44.2.41
AUD-001992026-09-03T16:30:37+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorEXPORTSDTM datasetDM.xpt—Export preview generated (DM domain)—10.12.4.31
AUD-001982026-09-03T14:10:58+05:30Director's Officedirector.officeInstitutional LeadershipVIEWStudyCTRI/2026/XX/SYN007—Record opened—10.44.2.17
AUD-001972026-09-03T09:53:30+05:30S. VenkatesansvenkatesanPrincipal InvestigatorUPDATESubject.visitAIIA-ARD-DEL-002Visit 6 — not doneVisit 6 — completedProtocol amendment v2.1 — re-consent captured10.12.4.31
AUD-001962026-09-03T09:05:12+05:30NPvCC Duty Officernpvcc.officerPharmacovigilance OfficerCODEAdverseEvent.AEDECODAE-022(uncoded)Dyspepsia — illustrative term set—10.9.1.22
AUD-001952026-09-02T12:42:23+05:30P. DaspdasStudy CoordinatorUPDATEObservation.valueQuantityAIIA-SAN-JAI-035 / SYSBP110 mm[Hg]105 mm[Hg]Monitor finding, CAPA reference MON-2026-01410.12.4.31
AUD-001942026-09-02T11:56:48+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorEXPORTSDTM datasetAE.xpt—Export preview generated (AE domain)—10.12.4.19
AUD-001932026-09-01T18:01:17+05:30R. MehrotrarmehrotraStudy CoordinatorUPDATEConsentAIIA-ONC-DEL-003Consent v1.0Consent v1.1Data clarification form received10.12.7.8
AUD-001922026-09-01T13:08:26+05:30A. SharmaasharmaData ManagerRAISEDataQueryQ-8603—Query raised on AIIA-MED-DEL-002—10.12.4.19
AUD-001912026-09-01T11:38:38+05:30P. DaspdasStudy CoordinatorCREATEAdverseEventAE-001—Vomiting · AESER=N—10.9.1.5
AUD-001902026-09-01T10:45:30+05:30A. KrishnamurthykkrishnamurthyPrincipal InvestigatorSUBMITSAE initial reportSAE-006PendingTransmitted to Sponsor, EC, CDSCO—10.44.2.17
AUD-001892026-09-01T08:49:28+05:30CDSCO Inspectorcdsco.inspectorRegulator (read-only)VIEWAuditTrailaudit—Audit trail inspected—10.12.4.31
AUD-001882026-08-31T17:46:58+05:30P. DaspdasStudy CoordinatorUPDATEObservation.valueQuantityAIIA-ONC-DEL-005 / SYSBP127 mm[Hg]129 mm[Hg]Source data verification — transcription corrected10.44.2.41
AUD-001872026-08-31T16:05:05+05:30CDSCO Inspectorcdsco.inspectorRegulator (read-only)EXPORTSDTM datasetDM.xpt—Export preview generated (DM domain)—10.44.2.17
AUD-001862026-08-31T14:51:50+05:30S. VenkatesansvenkatesanPrincipal InvestigatorUPDATEConsentAIIA-GRH-DEL-006Consent v1.0Consent v1.2Query response from site10.9.1.22
AUD-001852026-08-31T12:14:15+05:30S. VenkatesansvenkatesanPrincipal InvestigatorVIEWStudyCTRI/2026/XX/SYN009—Record opened—10.12.4.31
AUD-001842026-08-31T09:22:14+05:30A. SharmaasharmaData ManagerRAISEDataQueryQ-7771—Query raised on AIIA-ONC-DEL-004—10.12.4.19
AUD-001832026-08-30T15:52:49+05:30R. MehrotrarmehrotraStudy CoordinatorCREATEAdverseEventAE-007—Dry mouth · AESER=N—10.44.2.41
AUD-001822026-08-30T12:07:37+05:30NPvCC Duty Officernpvcc.officerPharmacovigilance OfficerCODEAdverseEvent.AEDECODAE-029(uncoded)Insomnia — illustrative term set—10.12.7.8
AUD-001812026-08-30T10:25:32+05:30NPvCC Duty Officernpvcc.officerPharmacovigilance OfficerCREATEAdverseEventAE-024—Dyspepsia · AESER=N—10.12.4.19
AUD-001802026-08-30T10:07:04+05:30P. DaspdasStudy CoordinatorCREATEAdverseEventAE-006—Nausea · AESER=N—10.12.7.8
AUD-001792026-08-29T17:24:52+05:30IEC Secretariatiec.secretariatEthics CommitteeAPPROVEProtocolAIIA/IEC/2026/140Under reviewApproved—10.44.2.41
AUD-001782026-08-29T12:03:45+05:30S. VenkatesansvenkatesanPrincipal InvestigatorEXPORTSDTM datasetDM.xpt—Export preview generated (DM domain)—10.12.4.19
AUD-001772026-08-29T10:54:31+05:30NPvCC Duty Officernpvcc.officerPharmacovigilance OfficerCODEAdverseEvent.AEDECODAE-011(uncoded)Pruritus — illustrative term set—10.44.2.17

Showing 60 of 236 matching entries (236 retained). No edit or delete control exists on this page.

ALCOA+ data integrity

The nine principles the audit trail requirement traces back to, and how this system satisfies each

A

Attributable

Every entry carries the user id, role and IP of whoever created or changed it. No shared logins.

L

Legible

Values are stored as readable text with the old and new state side by side; nothing is overwritten in place.

C

Contemporaneous

Entries are stamped to the second in ISO 8601 with a fixed IST offset at the moment of the action.

O

Original

AETERM verbatim text and first-capture values are retained; coding and corrections are added, never substituted.

A

Accurate

Any change to entered data requires a reason-for-change, which is stored on the audit row itself.

C

Complete

Repeat measurements, re-analyses and superseded values all remain in the trail — the log is append-only.

C

Consistent

One clock, one timezone, one sequence: rows are ordered chronologically and cannot be reordered.

E

Enduring

Retention takes the stricter of the DPDP Rules minimum (one year) and the trial retention obligation.

A

Available

The full trail is searchable and filterable for the whole retention period, including by an inspecting regulator.

Role permission matrix

What each role may do. The Regulator row is deliberately read-only across every write action.

RoleView portfolioEdit study recordEnter subject dataReport AE / SAECode AE termsApprove protocolExport datasetsView audit trailView participant identifiers
Principal Investigator
Study Coordinator
Ethics Committee
Pharmacovigilance Officer
Institutional Leadership
Regulator (read-only)

Electronic signature log

Each signature is bound to the specific record signed, with the meaning of the signature recorded

SAE narrative

AIIA-SAN-DEL-007

“SAE report authorised for regulatory transmission (PV Officer)”

A. Krishnamurthy

Principal Investigator

2026-09-04T16:47:00+05:30

SAE narrative

AIIA-SAN-DEL-007

“Medical review completed — causality assessed (Investigator)”

R. Mehrotra

Study Coordinator

2026-09-03T13:14:00+05:30

SAE narrative

AIIA-SAN-DEL-007

“Ethics Committee decision recorded (Chairperson)”

A. Krishnamurthy

Principal Investigator

2026-09-02T17:42:00+05:30

Protocol approval memo

aiia-yak-008

“Medical review completed — causality assessed (Investigator)”

IEC Secretariat

Ethics Committee

2026-09-01T13:35:00+05:30

Protocol approval memo

aiia-grh-003

“Reviewed and approved for database lock (Data Manager)”

A. Sharma

Data Manager

2026-08-29T11:19:00+05:30

eCRF — Visit 4 completion

AIIA-SAN-DEL-027

“Ethics Committee decision recorded (Chairperson)”

NPvCC Duty Officer

Pharmacovigilance Officer

2026-08-28T10:37:00+05:30

eCRF — Visit 4 completion

AIIA-SAN-JAI-030

“I confirm this record is complete and accurate (Investigator)”

Director's Office

Institutional Leadership

2026-08-24T14:34:00+05:30

Protocol approval memo

aiia-ard-010

“I confirm this record is complete and accurate (Investigator)”

S. Venkatesan

Principal Investigator

2026-08-22T11:01:00+05:30

eCRF — Visit 4 completion

AIIA-SAN-DEL-004

“Reviewed and approved for database lock (Data Manager)”

R. Mehrotra

Study Coordinator

2026-08-10T10:44:00+05:30

eCRF — Visit 4 completion

AIIA-GRH-DEL-014

“SAE report authorised for regulatory transmission (PV Officer)”

Director's Office

Institutional Leadership

2026-08-07T11:16:00+05:30

eCRF — Visit 4 completion

AIIA-SAN-JAI-030

“Medical review completed — causality assessed (Investigator)”

IEC Secretariat

Ethics Committee

2026-08-02T17:04:00+05:30

Protocol approval memo

aiia-mut-015

“Ethics Committee decision recorded (Chairperson)”

R. Mehrotra

Study Coordinator

2026-07-26T14:24:00+05:30

SAE narrative

AIIA-TAM-DEL-005

“Reviewed and approved for database lock (Data Manager)”

A. Krishnamurthy

Principal Investigator

2026-07-23T13:18:00+05:30

SAE narrative

AIIA-MAD-DEL-004

“I confirm this record is complete and accurate (Investigator)”

P. Das

Study Coordinator

2026-07-13T12:04:00+05:30

DPDP compliance

Digital Personal Data Protection Act, 2023 (enacted August 2023) and the Digital Personal Data Protection Rules, 2025 — notified 13 November 2025, published in the Gazette 14 November 2025. The Rules operationalise the Act and commence on a staggered, phased schedule.

Clinical trial data is sensitive personal data. Under the DPDP Act 2023 and the DPDP Rules notified in November 2025, AIIA is a Data Fiduciary with obligations on consent, notice, erasure and breach reporting. That is precisely why this demonstration runs entirely on synthetic data.

Consent management

Implemented

Versioned, specific and withdrawable. Re-consent is tracked on every protocol amendment and surfaced per participant.

Data minimisation

Implemented

Only protocol-required fields are collected. The participant record has no name, address or contact field at all.

Purpose limitation

Implemented

Trial data is bound to the registered study purpose, carried on Consent.provision.purpose as HRESCH.

Data residency

Designed

Deployment targets compliant, data-resident cloud infrastructure within India.

Security

Designed

Encryption at rest and in transit, ISO/IEC 27001 and CERT-In norms, role-based access.

Log retention

Implemented

Audit log and personal data retained for at least one year per the DPDP Rules; the configured policy takes the stricter of that and the trial retention obligation.

Breach notification

Roadmap

Personal data breach reporting workflow with Data Protection Board notification templates.

Data Principal rights

Designed

Access, correction and erasure — on erasure the Fiduciary must also ensure erasure by its Processors.

Who is who under the Act

Data Principal
The individual the data is about — The trial participant
Data Fiduciary
Entity determining the purpose and means of processing — AIIA
Data Processor
Entity processing on the Fiduciary's behalf — The CTMS hosting provider
Significant Data Fiduciary
Higher-obligation class — AIIA plausibly qualifies on volume and sensitivity
Consent Manager
Board-registered entity managing consent on an interoperable platform — Relevant to the consent architecture

Notice requirements (Rule 3)

  • An itemised description of the personal data to be processed
  • The specified purpose, with a specific description of the uses enabled
  • The means to exercise Data Principal rights
  • The process to complain to the Data Protection Board
  • A direct communication link to withdraw consent
  • Available in English or any of the 22 languages in the Eighth Schedule

On the healthcare exemption: The Fourth Schedule exempts clinical establishments and registered healthcare professionals from the verifiable parental consent obligation, but only for purposes necessary to providing health services and treatment. Clinical research is not clinical care — this system does not rely on that exemption and captures full consent regardless.