What this is, and who it is for
A Live design never changes. When the protocol changes, the study gets a new version, an amendment, which is built, tested and signed like the first and then taken Live. The version that is Live keeps running until the new one replaces it, and each participant moves to the new version one at a time, after consenting again where the amendment asks for it.
| You need | To |
|---|---|
study.amendment.start | Start an amendment |
form.design / study.write | Build it |
study.version.submit_uat, study.uat.close_cycle, study.version.signoff, study.version.go_live | Take it through the path (Review and release a study) |
study.version.go_live | Run the move of participants to it |
Held by: Organization Admin, Project Manager (study.amendment.start).
Where to find it
Study → Versions → Start amendment (offered when the study has a Live version, none is already in flight and the study still does version work: not when it is Completed, Locked or Archived). The new version's Build has an Amendment page; the version's own page shows the participants' move.
What you can do
1. Start it
The dialog Start an amendment says: Starts the next version in Build, cloned from the Live design. The Live version keeps running until the new one is tested, signed off by three people and taken Live.
| Field | Notes |
|---|---|
| What kind of version is it? | Amendment (a new major version: the protocol or its design changed) or Minor version (a configuration-only change to the design: a label, a window, an order) |
| Why is the study changing? | For an amendment: Protocol amendment (new visits, forms, schedule or arms), Eligibility / consent (criteria or the consent changed), Safety-driven (remove a dangerous field, stop an arm: expedited) or Rollback (return to a prior known-good design). A minor version is configuration only |
| Reason | Required, at least three characters. Example: Protocol amendment 2: add the Week-36 ECG visit and form |
| Subjects must be re-consented under this version | Switch on when the amendment changes what participants agreed to |
The new version is 2.0 (or 1.1 for a minor version), in Build, with a copy of every form as a Draft working copy, the visits, the mapping and the settings of the Live design.
- Starts the next version in Build beside the Live one.
2. Build the change
Work in Build as usual (Build a study). Two things differ:
- A field that exists in the Live version cannot be deleted (it may hold data); it is deprecated with a reason, and an option, unit or table column that Live data uses cannot be removed or changed (Versions, reopening and publishing).
- The Amendment page lists, for this version:
- Why it was started;
- Changes against the Live version: one row for each form, field, visit, binding and rule that differs, with its Kind (form, visit, rule, mapping or settings), What, Change (added, updated, deprecated or removed) and Impact, Low, Controlled or Breaking, with the reason ("The code-list value … no longer exists, and the field holds Live data");
- Fits the data already captured: NOTHING BREAKS, or each breaking change with Fix it in Forms;
- Live subjects it will reach: counts by site and status of the participants the version would reach (counts only; no participant is named). The counts of Live participants are read from the Live workspace, so they show while you are in Live. No Live subject is reached by this version when everyone already follows another.
The comparison is made when the version is submitted to UAT. A Breaking change is refused at the submission and again at go-live.
- One row for each change against the Live version, with its change and its impact.
- Why it was started, and whether re-consent is required.
- Whether any change would stop data already captured from fitting.
- Counts of the Live subjects the version would reach; they show while you are in Live.
3. Test, sign and take it Live
Exactly as for the first version: submit to UAT, test, pass, three sign-offs, go live (Test a version in UAT, Sign off a version and go live). For an amendment, the go-live checklist adds The SDV plan carries over: every verification requirement of the version being replaced must still have its form, field and visit in the new one.
Going Live promotes the configuration only. No participant moves by itself.
4. Move the participants
On the amendment's Version details page, the move panel shows a bar and legend of the study's participants:
| Segment | Meaning |
|---|---|
| follow 2.0 | Already on the new version |
| ready to move | Can follow it now. With re-consent required, those who consented |
| waiting for their consent | Re-consent required and not yet answered (shown only when re-consent is required) |
| declined | Said no to the amendment; they stay on 1.0 and the site decides what the protocol requires |
Choose Move N subjects. The move takes one participant at a time (each its own transaction), is safe to run again, and reports what it did: moved 7 subjects, retired 14 visits that never were, gave 21 visits of 2.0. A participant it could not move is listed (2 subjects could not be moved and are still to move) and is retried next time. A participant who consents later moves on the next run. Show who lists the participants, by site, for those who may read participants.
When a participant moves, their visits that never took place are retired and replaced by the new version's, and forms the amendment added are captured by protocol visit: a form added by the amendment can be recorded for a participant who follows it, on the visit with the same code, as long as the visit did not already have that form. Their earlier data stays, tied to the version it was captured under.
Re-consent
When the amendment asks for it, each site records the participant's answer on the participant's Consent page (Record consent and re-consent).
Every option
How a change is classified
| Impact | Meaning | Examples |
|---|---|---|
| Low | Reads the same to data already captured | A label, help text, position, layout, the wording of a message |
| Controlled | Changes what is enforced or collected from now on | A field made required, a check or its severity changed, a formula, a column added, a field deprecated |
| Breaking | Would no longer fit data the study holds | A field's type changed, an option removed, a unit changed or removed, a column or row removed, a field deleted, where the field holds Live data |
The full list is on Versions, reopening and publishing.
Withdraw an amendment
An amendment that will not be used is withdrawn with a reason; the Live version is unaffected.
What the system records
study.amendment.started (kind, reason, whether re-consent is required), the version events of the path, subject.reconsented or subject.reconsent_declined, subject.version_transitioned for each participant moved and visit.instance_retired for each retired visit. See Audit events.
What you cannot do, and why
- Change the Live design in place. Only a new version changes it.
- Start a second amendment while one is in flight.
- Start an amendment on a Completed, Locked or Archived study. The study no longer does version work, so Start amendment is not offered, and the server refuses it (versions can no longer be started, edited or tested).
- Take an amendment Live with a breaking change. Add a new field and deprecate the old one.
- Move a participant who has not consented again when re-consent is required, or force one who declined.
- Withdraw a participant from the study by declining. The platform withdraws nobody; the site withdraws the participant if the protocol says so.
Compliance Q&A
Yes. An amendment is a new version that goes through the same UAT and three sign-offs; each change is classified by its effect on captured data and dangerous ones are refused; the move of a participant to the new version waits for a recorded re-consent when the amendment requires one.
Limits: the system records consent and moves participants; whether an ethics committee approved the amendment at a site is recorded as a document and a date, not enforced (Not built yet).
Evidence: server/src/modules/study/versions (amendment start, change-impact, transition-subjects)subjects record-reconsentADR 0016 decisions 3 to 9
Related
Review and release a study · Record consent and re-consent · Correct a design after UAT · Versions, reopening and publishing · Statuses