ISO 14155 sets good clinical practice for clinical investigations of medical devices. It expects validated electronic systems, complete records and structured reporting of adverse events and device deficiencies. Here is what that means for your EDC.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Date observed
DDDTCDeficiency type
DDTYPECould it have led to a serious adverse device effect?
DDSADELinked adverse event
DDAEKey points
Data management
ISO 14155 expects sponsors to use electronic systems that are validated for their intended use, protect data from unauthorised access and change, record changes in an audit trail, and allow data to be traced back to source. Those are the same principles behind 21 CFR Part 11 and GCP for medicines, applied to device studies.
In practice that means a field-level audit trail with reasons for change, role-based access with site separation, electronic signatures that are re-authenticated, and locked, approved forms so data collection does not change silently. Capture provides those controls; validation for your intended use remains the sponsor's responsibility, supported by documentation on Enterprise plans. See 21 CFR Part 11 compliant EDC.
Device studies record things drug trials do not: device identifiers and lot numbers, procedure details, operator experience, device performance measures and deficiencies. Build them as structured fields so they can be analysed and reported.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Safety reporting
| Term | Meaning |
|---|---|
| Adverse event (AE) | Any untoward medical occurrence in a participant, whether or not related to the device |
| Adverse device effect (ADE) | An adverse event related to the use of the device |
| Serious adverse event (SAE) | An adverse event meeting seriousness criteria, such as death or hospitalisation |
| Serious adverse device effect (SADE) | An adverse device effect that meets seriousness criteria |
| Unanticipated SADE (USADE) | A SADE not identified in the risk analysis |
| Device deficiency | Inadequacy in identity, quality, durability, reliability, safety or performance, such as malfunction or use error |
Check the exact definitions and reporting timelines in the standard and the regulations that apply to your investigation.
In Capture
Adverse events use the AE form with the minimum dataset enforced, and serious events raise routed safety alerts with the SAE timeline tracked from site awareness. Add a device deficiency form and device relationship fields to the same study, so every event and deficiency is linked to the participant and device.
SAE timeline
SAE reported
Day 0 · 09:12
Safety alert acknowledged
Medical monitor · 09:40
Site staff attestation
Study coordinator · 11:05
AE sign-off (PI / Sub-I)
Awaiting signature
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After approval
Device evidence does not stop at market approval. Under the EU MDR, manufacturers run post-market clinical follow-up to confirm safety and performance over the device's lifetime, often for years. Patient-reported outcomes such as the KOOS and Harris hip score or Oswestry Disability Index, completed remotely, keep follow-up practical.
Keep definitions and forms consistent between the pre-market investigation and post-market follow-up so data can be compared. See post-market clinical studies.
Study build
Validation for intended use documented.
Identifiers, lots, procedure and performance fields.
AE, ADE, SAE, SADE and device deficiency.
Per the standard and applicable regulations.
Source verification of critical data.
Consistent forms for post-market follow-up.
It is an international standard used in many countries. Check local requirements for your investigation.
Among others, the clinical investigation plan, investigator's brochure, case report forms, safety reports, monitoring records and the clinical investigation report.
The international standard for good clinical practice in clinical investigations of medical devices in human subjects. The current edition was published in 2020.
No, but electronic systems used must be validated and maintain data integrity, including audit trails and access control.
An inadequacy of a device in identity, quality, durability, reliability, safety or performance, such as a malfunction or use error.
ISO 14155 applies to how a clinical investigation is conducted, not to software certification. Capture provides controls such as audit trails, e-signatures and access control that support compliant conduct.
Yes. Long follow-up schedules with remote questionnaires and reminders are supported.
Yes, in the free sandbox with every feature.
Keep exploring
Safety, deficiencies and follow-up in one study. Free sandbox.