Safety reporting & blinding

Safety reporting and sponsor blinding on every HCP interview

Every transcript is screened for adverse events, with reports to your drug-safety team within 24 hours and a full reconciliation at study end, in every interview language. Studies are sponsor-blinded by default and de-identified to the HIPAA Safe Harbor standard, with a BAA available.

Safety reporting within 24h
Sponsor blinding by default
De-identified results
Verified clinician on a Carevoices research interview
Live
carevoices.health/dashboard
Study Dashboard 3 Active
24h
Safety reporting
18
Identifiers removed
Blinded
Sponsor, by default
Response Trend 7 days
Choose study type
Blinded KOL interviews
Message testing
Concept testing
ATU & trackers
Blinded Sponsor, by default
Fielding
Live
Definition

What is adverse-event reporting in market research with Carevoices?

Adverse-event reporting in market research means catching any side effect, product complaint or other safety information a clinician raises during a study, and passing it to the sponsor's safety team within a set window. On a Carevoices study that window is 24 hours, and it runs alongside sponsor blinding and HIPAA Safe Harbor de-identification, so one process answers your PV, compliance and privacy reviewers.
What you get

Safety reporting your PV team can sign off

Every study ships with the safety record your drug-safety or complaint-handling team needs, alongside the research itself.

Reports within 24 hours

Each adverse event or product complaint a clinician raises reaches your named safety contact within 24 hours, in every interview language.

A study-end reconciliation

A full reconciliation at study end, so your PV team can confirm every report against the interviews that ran.

A blinded study record

Invitations, screeners, consent and the interview never name the commissioning company, unless unblinded work is agreed in the study plan.

De-identified deliverables

Transcripts and findings de-identified to the HIPAA Safe Harbor standard, with no audio or video shared by default.

Compliance built in

What your safety team gets

On by default, in every interview language. Your drug-safety or complaint-handling contact is named in the study plan.

Safety reporting

Every transcript is screened for adverse events, with reports to your drug-safety team within 24 hours and a full reconciliation at study end, in every interview language. For medical devices, product complaints and potential adverse events raised in an interview are reported to your complaint-handling team within 24 hours, with a reconciliation at study end.

Sponsor blinding

Sponsor-blinded by default: participants never learn who commissioned the study. Invitations, screeners, consent and the interview never name the commissioning company. Participant consent includes the adverse-event disclosure the market-research codes require.

De-identified results

Every deliverable is de-identified to the HIPAA Safe Harbor standard, with all 18 identifiers removed. Insights deliverables never include participant identities, and no audio or video is shared by default. Contact details reach the sponsor’s drug-safety team only if the clinician agrees to adverse-event follow-up; any unblinded work is agreed in the study plan.

Data protection

HIPAA-enabled, with a BAA available. SOC 2 Type II compliant. Run in line with the EphMRA, BHBIA and Insights Association codes of conduct.

How it works

From brief to a reconciled safety record

A proposal within 24 hours of your brief, and results in 1–2 weeks from plan approval.

1
Brief and plan

Safety route agreed

A proposal within 24 hours of your brief. The study plan you approve names your drug-safety or complaint-handling contact.

2
Fielding

Every transcript screened

Each transcript is screened for adverse events, product complaints and other safety information, in the language the interview ran in.

3
Within 24 hours

Safety report sent

A report reaches your drug-safety team, or your complaint-handling team for a device, within 24 hours of the interview.

4
Study end

Reconciled, de-identified results

A full reconciliation arrives with the Safe Harbor de-identified transcripts, in 1–2 weeks from plan approval. Whether a report meets a regulatory obligation remains your determination.

Compare

Carevoices vs. general AI interview tools vs. traditional fieldwork

Dimension Carevoices General AI interview tool Traditional HCP fieldwork
Adverse-event screening Every transcript, every interview language Left to the sponsor Through the vendor's PV process
Reporting window Within 24 hours, reconciled at study end Not defined Varies by vendor
Sponsor blinding By default Set up by the sponsor Varies by vendor
De-identification HIPAA Safe Harbor, all 18 identifiers Raw transcripts and recordings Varies by vendor
Participants Identity, license and NPI verified Consumer or self-attested panels Panel-dependent
FAQs

Frequently asked questions

Every transcript is screened for adverse events, with reports to your drug-safety team within 24 hours and a full reconciliation at study end, in every interview language. The 24-hour window runs from the interview in which the safety information was raised. Whether a report meets a regulatory reporting obligation remains the sponsor's determination.
For medical devices, product complaints and potential adverse events raised in an interview are reported to your complaint-handling team within 24 hours, with a reconciliation at study end. Whether a complaint meets a regulatory reporting obligation remains the sponsor's determination.
Participant consent includes the adverse-event disclosure the market-research codes require. Run in line with the EphMRA, BHBIA and Insights Association codes of conduct.
No. Sponsor-blinded by default: participants never learn who commissioned the study. Stimuli are reviewed so they do not reveal the sponsor, and unblinded work, such as an advisory board you run directly, is agreed in the study plan.
All 18 HIPAA identifiers, from names and geographic subdivisions smaller than a state to dates, contact details and record numbers. Insights deliverables never include participant identities, and no audio or video is shared by default.
Yes. Carevoices is HIPAA-enabled, with a BAA available. The BAA template, the SOC 2 Type II report and the penetration-test summary are listed on the compliance page; the reports are shared under NDA.
SOC 2 Type II compliant. Encrypted in transit (TLS 1.2+) and at rest (AES-256). Customer and participant data is never sold and never used to train AI models. Single sign-on and audit logs. US or EU data residency. Data is deleted within 30 days of a written request, unless the law requires it to be kept.
Bring your safety team

Field HCP research your PV team signs off on

Send a brief and get a proposal within 24 hours. Your drug-safety and compliance reviewers are welcome on the call.

Proposal within 24 hours

Tell us the specialty, interview count and timing.

30-minute call

Walk through safety reporting, sponsor blinding and the BAA.

Explore More

Related resources

Built for these teams

Deep-dive guides covering this topic from strategy to execution.

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Practical frameworks and platform-specific guides for teams ready to act.

Compliance reference reading

Reference deep-dives on methodology, best practices, and applied research.

How Carevoices compares on compliance

Side-by-side comparisons with competing platforms and approaches.

More platform capabilities

The platform features that power this type of research.