The sponsor owns the trial data, but ownership means little if the data is hard to get out. Portability means complete exports in open formats, with the audit trail, signatures and study design, whenever you need them. Here is what to check.
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| SUBJ | ECGPERF_CODE | ECGPERF_LABEL |
|---|---|---|
| 01-001 | Y | Yes |
| 01-002 | ND | Not done |
Key points
Why it matters
Vendor lock-in rarely comes from a single decision. It builds up: data in a proprietary format, an audit trail that can only be viewed on screen, study designs that cannot be reused elsewhere, and exit fees nobody read in the contract. When a sponsor wants to switch vendors, merge data from several studies, or respond to an inspection years later, those gaps become expensive.
The answer is to treat portability as a requirement from the start. Test exports during evaluation, check that they are complete and documented, and write exit terms into the contract. See the EDC RFP template for questions to include.
Trial records must be kept for years after a trial ends, with the exact period depending on the regulations that apply. Plan how data will be retained and retrieved after the study closes, including if you stop using the vendor.
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
What to export
| Component | Why you need it | In Capture |
|---|---|---|
| Clinical data | Analysis, archiving, migration | CSV and Excel, wide format, filters by date, site or participant |
| Data dictionary | Understanding every variable | Automatic data dictionary with codes and labels |
| Audit trail | Inspections and data integrity | Exportable, filterable by participant and date |
| Signed consent | Proof of consent | Signed PDFs with signature data, timestamps and audit trail |
| Study design | Archiving and reuse | Blank eCRF and ePRO PDFs; configuration export and import |
| Queries and safety | Records of data review and reporting | Query list CSV; safety listings and E2B export |
In Capture
Clinical data exports as CSV or Excel with an automatic data dictionary, in raw and decoded versions, filtered by date range, site or participant. Signed consent documents export as PDFs with embedded signature data, and study configurations export for reuse in a new study.
| SUBJ | ECGPERF_CODE | ECGPERF_LABEL |
|---|---|---|
| 01-001 | Y | Yes |
| 01-002 | ND | Not done |
Enter test data in the free sandbox and download every export.
Questions to ask
Can we export all clinical data, at any time, without a support ticket? Does the export include a data dictionary? Can we export the full audit trail, including values that were changed? Can we export signed consent documents with their signature evidence? Can we export the study design in a reusable form? What happens to our data at the end of the contract, in what format, how quickly, and at what cost?
Ask for an example export during evaluation and open it yourself. If it takes a vendor project to produce, it will take one again when you need it. See how to switch EDC vendors mid-study.
Evaluation
Available to your team at any time.
Included with every export.
Complete, including changed values.
Consent and signature evidence exportable.
Blank forms and reusable configuration.
Formats, timelines and costs in the contract.
It depends on the regulations that apply; many require retention for years after the trial ends.
Yes. Exports are available at any time, filtered by date range, site or participant.
The sponsor is responsible for trial data and its retention. Contracts should confirm the sponsor's rights and how data is returned.
Open formats such as CSV, with a data dictionary, plus PDFs for signed documents and blank forms.
In Capture, yes. It can be filtered by participant and date and exported.
Capture exports blank eCRF and ePRO PDFs and study configurations that can be imported into a new study.
Yes. CSV and Excel exports can be filtered to one participant, one site or a date range.
Yes, in the free sandbox with sample data.