- Specializing in Creating Customized IVRs, Voice, SMS, Chat and HIPAA Compliant Secure Message Applications
Specializing in Creating Customized IVRs, Voice, SMS, Chat and HIPAA Compliant Secure Message Applications
Audit-Enabled Surveys for Clinical Trials
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An audit trail for phone, text and secure surveys that lets your QA team reconstruct any response
When an inspector or your own QA lead asks which question a participant heard on 12 June, nobody should have to rebuild the answer from old scripts and email threads. In regulated study mode, IVR Lab keeps that answer in the record. Each change is logged. Each published version of the survey is frozen. Each response points back to the exact version, wording and recorded prompt that produced it.
Regulated mode covers voice (IVR) campaigns, SMS surveys and secure link surveys. It is one part of our IVR and SMS ePRO for clinical trials work, and it is the part QA teams tend to ask about first.
21 CFR Part 11 and FDA guidance
FDA doesn’t certify software for Part 11, so no vendor can hold that certification, us included. Our audit trail was written against the audit trail and record integrity expectations of 21 CFR Part 11 and FDA guidance on electronic systems in clinical investigations. Whether those requirements apply, and how, depends on how your study uses the records. Compliance comes from your validated use of the system. We supply the controls, the documentation and the help.
Planning a clinical trial IVR or participant reminder workflow?
Share your schedule of assessments, draft questionnaire, or patient communication flow. We will review it and outline a practical approach.
Request a workflow review- Who: The named user. When our support staff act on your account, both identities are recorded, separately
- What: the record affected, such as a participant, list, campaign, question, response, recording, transcript, user or permission.
- When: A server timestamp with its offset, never taken from a browser or a participant's phone.
- Before and after: The previous value and the new value.
- Why: A reason, required for the changes that matter most.
- Publishing a change to a survey or diary.
- Archiving or withdrawing study items.
- Changing a participant's enrollment or status.
- Replacing a recorded prompt.
Frozen survey versions
A study workflow is never edited in place. Saving a change publishes a new numbered version and stores a complete, frozen copy of the configuration as it stood at that moment.
- Every question in order, with its exact wording.
- Answer options and branching rules.
- The schedule and contact windows.
- Translated wording for each language offered.
- The specific recorded prompts used.
- Who published it, when, and the reason given.
- A SHA-256 fingerprint of the stored copy, so you can show it hasn't been altered.
- A version number. In the audit report the whole number identifies the instrument participants answered, and the decimal moves for administrative changes such as a redial setting.
- Open any frozen version in readable form or as the original stored file.
- See what changed between two versions side by side.
- Every participant response links to the version that produced it. That link is what makes reconstruction exact rather than a best guess.
Responses stay as given
- Nobody can edit a response: not site users, not account administrators, not IVR Lab support staff.
- Nobody can delete a response. A duplicate enrollment, test call or known data-entry problem is set aside with a status and a reason by a named user, at a recorded time.
- Original audio for spoken answers is kept as captured and never replaced by its transcript.
- Transcripts are stored separately with the transcription service and job reference. If one is corrected, the earlier text stays alongside, with who, when and why.
- A keypad answer is stored with the label shown for that key at the time, so later wording changes can't change what an answer meant.
Enrollment kept as history
- Every enrollment, withdrawal, reinstatement, status change and contact schedule change is recorded with old and new values.
- Participants with study activity are never deleted. Status changes such as withdrawn, completed or entered in error carry a reason.
- Periodic snapshots record exactly who was in each participant group, so "who was enrolled on 14 October?" is answered from the record.
- A participant group used in a regulated study is locked to that study. It can't be reused for other work or deleted, though a copy can be taken.
- A keypad answer is stored with the label shown for that key at the time, so later wording changes can't change what an answer meant.
How the audit trail protects itself
- Entries are written once. No function edits or deletes them, for any role, including our administrators.
- Audit recording can't be switched off for a study once it is running.
- If an audit entry can't be written, the action it describes doesn't go through.
- Every person works under an individual account. Shared logins are not utilized.
- Production database access is restricted to authorized technical staff. Any direct intervention follows an approved procedure, is tied to a named person and is recorded separately.
Audit reports you can open, check and hand over
- One view of audited campaigns across voice (IVR), SMS survey and secure survey types.
- Change history and frozen version tabs for each campaign.
- Report links that work once and are tied to your session.
- Version history with fingerprints and reasons.
- The survey as delivered.
- Fingerprints for each recorded prompt.
- The change log, with each value before and after and the reason.
- Enrollment snapshots.
What’s available: Frozen copy of a version, compute its SHA-256 and compare it with the fingerprint in the report. Do the same for any recording.
- A full audit package on request.
- The complete change history as a spreadsheet, with old and new values.
- Enrollment records.
- Response data with version stamps.
- A fingerprint manifest for independent checking.
- Full package requests go to our compliance team, and we confirm authorization before anything is released.
Questions the record is built to answer
Audit records are kept at least as long as the study records they describe. On request, and during an inspection, we can produce the audit trail for a study, a participant, a workflow or a date range in a searchable, sortable, machine-readable format, without pulling in engineers. Typical questions:
- "Show me the configuration in effect on 12 June, when this participant received this call."
- "Show me every change made to this study workflow between 1 May and 1 July."
- "Who changed this question, when, and why?"
- "Which version of the workflow produced this response?"
- "Provide the audit trail associated with this record."
Talk to us about your clinical trial IVR requirements.
Send us your protocol schedule, questionnaire, or patient communication plan and we will tell you how we would approach the workflow and what inputs we would need from your team.
Discuss your study workflowFrequently asked questions
Planning a clinical trial IVR or participant reminder workflow?
Share your schedule of assessments, draft questionnaire, or patient communication flow. We will review it and outline a practical approach.
Request a workflow review