There is no one-click import of a Rave study, and the hard part is rarely the forms. It is the contract, the data you must be able to prove, and the date you cut over. Here is a plan a data manager can follow and a sponsor can audit.
Free sandbox · No credit card · 21 CFR Part 11 aligned
weeks
Notice, export rights
What to know first
Why teams look
Medidata Rave is a widely used enterprise EDC, and for large global programmes with established processes it can be the right system. Teams start searching for an exit for reasons that are mostly structural rather than technical: a build that is ordered from a services team, protocol amendments that go through change control with a quote attached, a contract term longer than the study plan, and modules for ePRO, randomization or consent that are bought and configured separately.
Before you move anything, put those questions to your current vendor in writing. A clearer quote or a shorter amendment turnaround may be the cheaper fix. If it is not, the Medidata Rave alternatives page lays out the evaluation criteria and Medidata vs Capture is the side-by-side. Protocol amendments without change orders shows how amendment control works when your own team holds the builder.
Be honest about timing. A migration that is announced two weeks before an interim analysis is a risk to the dataset; a migration planned before the next protocol starts is just a project.
The path
Written for a sponsor or CRO moving the next study, cohort or protocol. Moving a study that is already recruiting is possible but needs the extra care described under mid-study moves.
Find the term, the notice period, auto-renewal, who may export what and in which format, and whether archiving or extra extracts carry a fee. Write the earliest possible exit date next to your study calendar.
Pick one date after which no new data enters the old system. A single date is easier to document in the data management plan and to explain to sites than a gradual hand-over.
Request the study data in the formats your contract provides, the audit trail, the query history, the signed documents, and the build specification or annotated CRF. Store them with the trial master file with a note of date, extract version and who generated them.
Open a draft form in Capture and upload the specification or annotated CRF as CSV, XLSX, PDF or DOCX. The AI drafts questions, choice lists and lab tables. It flags what it cannot match. Nothing is saved until a person approves it.
Recreate the visit schedule and windows, branching as skip logic, and your range and custom-value rules as edit checks that raise auto-queries. Use the built-in calculators for derived values such as BMI or eGFR where they apply. Simplify any logic that depended on custom functions.
Run sample participants through every visit, break each check on purpose, sign, and review the audit trail. Keep the scripts and results as validation evidence. See computer system validation.
Give each role the right access, show coordinators how queries and signatures work, and set the date. Add a site, share its QR code or invitation, and enrol from the cut-over date.
Keep the Rave export as the record of everything collected before cut-over. Write a one-page variable map pairing old and new names, and join the two datasets on participant identifier during analysis.
Data mapping
Category-level guide using generic enterprise-EDC terms. Check each line against your own build.
| Item in the old system | Where it goes in Capture | Effort |
|---|---|---|
| Forms, fields and choice lists | AI-drafted from an uploaded specification, then reviewed field by field | Low to moderate |
| Visit schedule and windows | Rebuilt in the visit editor, or drafted from the protocol document | Low to moderate |
| Edit checks and derivations | Range and custom-value edit checks with auto-queries; built-in clinical calculators | Moderate |
| Custom functions or scripted logic | Rewritten as skip logic or edit checks; simplify what cannot be expressed | Moderate to high |
| Subject data collected so far | Stays in the original export; merged with the Capture export at analysis | Mapping exercise |
| Queries and audit trail history | Archived with the trial master file; not copied into the new audit trail | Archive task |
| Roles and site users | New accounts with researcher, site coordinator and admin roles | Low |
| Randomization and supply setup | Reconfigured in Capture randomization and kit management if the study uses them | Moderate |
| Standards such as CDISC SDTM outputs | Capture exports SDTM datasets as SAS XPT with Define-XML; compare the mapping to your existing specification | Review |
Capture does not copy another system's audit trail into its own. The audit trail starts with the first entry in Capture.
The free sandbox includes every feature. Compare the draft with the original and time the review.
The slow part, sped up
In a services-led build, forms arrive from a team that interprets your specification. In Capture you hold the builder. Upload the specification and the AI proposes the structure; your data manager spends the time on what matters, such as units, required flags, ranges and the link between a form and a visit.
Drafted from uploaded specification
Systolic blood pressure
VSORRESAI proposed range 70 to 220 · review
Diastolic blood pressure
Heart rate
Position
Be realistic
Your data does not move automatically. Capture does not import a Rave study. Historical subject data stays in the export you take from the old system and is merged at analysis. If your statistical plan needs one continuous dataset, agree the variable map and the code lists before the first participant is entered in Capture, not after.
History does not move. Query threads, the old audit trail and signature records are archived as documents. The audit trail in Capture starts at the first entry; it is field-level, append-only and records user, time, old value, new value and reason for change.
Custom logic may need to be simplified. Anything written as scripted functions or unusual derivations has to be re-expressed as skip logic, edit checks or one of the built-in calculators. List these early; they are where the review time goes.
Integrations are rebuilt, not copied. If your current study feeds a coding tool, a safety database or a lab data feed, decide how each connection will work after the move. This page does not claim a connector for any of them, and medical coding of adverse events and medications is a process you should keep in place and document. Capture does export SDTM datasets, so the downstream statistical flow is easier to reproduce than the connections around it.
Training and SOPs change. Your data management plan, CRF completion guidelines and site training slides need a new version number. Budget for that as a task, not an afterthought. The 21 CFR Part 11 compliance checklist is a good frame for what the sponsor should verify in any EDC.
Validation and cutover
Notice period, export entitlements and any fees written down and signed off by procurement.
Data, audit trail, queries, signed documents and specification stored with the trial master file.
Old to new names, units and codes approved by the statistician before the build is locked.
Every old rule listed, rebuilt or deliberately retired with a reason.
Sandbox scripts, expected and actual results, deviations and approvals.
Whether participants need to be informed; prefer a new study or cohort for the move.
Roles assigned, a short guide issued and a date after which only Capture is used.
New version describing the system, the cut-over date and the merge approach.
If you cannot wait
Sometimes the contract ends before the study does. In that case the cut-over date is a design decision with consequences: every participant mid-way through the visit schedule will have some visits in Rave and the rest in Capture. Build the Capture schedule so that it starts at the next visit, carry the participant identifier across unchanged, and record the rule in the data management plan. How to switch EDC vendors mid-study walks through the risks in more detail.
Run the sandbox rebuild in parallel with the live study so that nobody has to guess how long your forms take. It is free and costs nothing if the answer is to stay.
Items done
5 of 8
Cut-over date
Set
What changes
No. There is no direct import. Export your data and build specification, use AI to draft the new forms from an uploaded CSV, XLSX, PDF or DOCX, rebuild logic and checks, and merge historical data at analysis.
The term and notice period, auto-renewal, what you may export and in which formats, and whether archiving or additional extracts carry fees. These set your earliest realistic cut-over date and are worth reading before you plan the technical work.
Archive them with the trial master file. They are not copied into Capture. The audit trail in Capture starts at the first entry and is field-level and append-only.
Prefer a boundary such as a new study, cohort or protocol. If the contract forces a mid-study move, choose one cut-over date, keep participant identifiers unchanged and document the rule in the data management plan.
The AI produces a first draft in minutes; review time depends on the number of forms and how much custom logic there is. Time one or two forms in the free sandbox to estimate the rest.
Yes. Capture exports SDTM datasets as SAS XPT files with Define-XML. Compare the mapping with your current specification during testing.
Yes, keep it. This page does not describe built-in coding, so continue with your current coding tool and dictionary licence and document how coded terms reach the analysis dataset.
No. The free sandbox has every feature with sample data, no credit card and no time limit. You pay only once you go live with real participants.
Keep exploring
Medidata Rave alternatives
The evaluation criteria for enterprise EDC.
Capture vs Medidata
Head-to-head comparison.
How to switch EDC vendors mid-study
If the contract ends before the study.
Protocol amendments without change orders
Amend your own study.
Hidden EDC fees
A checklist for the quote you hold.
CRF builder for clinical trials
AI drafting, edit checks, calculators.
Upload a specification in the free sandbox, review the draft and decide with evidence. No credit card, no sales call.