Sites, subjects, and casebooks

Review status

Included in the proposed model: EDC Site Participation, Site Design Assignment, Subject, Screening Attempt, Casebook, Casebook Design Assignment, Subject Status History, and Visit/Form occurrences.

Settled proposal: informed consent must be obtained before study-specific screening procedures or data collection. The subject and casebook are then normally created when consent is confirmed and screening starts, because screening data are themselves collected in CRFs.

Open: rescreen identity, subject transfer, multiple concurrent casebooks, and ownership when another system screens the subject first.

Clinical purpose

This area connects an approved EDC design to a real site and then to each screened participant. It answers three practical questions:

Is this site allowed and ready to enter data in this EDC study?
Which design applies when this subject begins screening?
What clinical-data record follows the subject throughout conduct, cleaning, and finalization?

EDC Site Participation

EDC keeps its own participation record for each Study Site.

Field	Clinical meaning
Study Site reference	Canonical site identity from Platform
EDC status	Configured, readiness confirmed, active, suspended, closed
Active design	Published design used for newly created casebooks
Effective time	When the assignment or status became effective
Activation basis	Required approval and readiness evidence
Authorized decision maker	Person/role that activated, suspended, or closed EDC participation
Reason	Required for suspension, reactivation, closure, and correction

Status journey

Configured
→ Readiness confirmed
→ Active for EDC
→ Suspended
→ Reactivated
→ Closed

Site activation in CTMS, Study Startup, or Platform is not automatically EDC activation. EDC may consume their milestone evidence but records its own decision because it must also know the approved collection design, production readiness, access readiness, and effective time.

Activate site for EDC

The action requires:

active EDC product participation for the study;
an available, approved, published design;
the site-relevant regulatory/ethics approval facts required by study policy;
EDC readiness checks completed;
responsible investigator and delegated users established where required;
activation authority; and
effective date and evidence.

Activation publishes the site’s active design for new casebooks. It does not silently move existing casebooks to that design.

Subject

The Subject is the EDC study participant record. It is not a login identity and does not expose the person’s direct identity to the sponsor.

Field	Clinical meaning
Stable subject identity	Internal identity that survives subject-number correction
Subject number	Sponsor-visible coded identifier
Number history	Prior numbers, reasons, actors, and effective times
Site	Current accountable EDC site
Screening number	When distinct from subject number
Screening and enrollment facts	Dates, outcomes, and evidence
Current disposition	Derived from retained status facts, not an overwritten label
Privacy classification	Controls exposure of any sensitive/restricted subject data

EDC may record a Consent Confirmation before screening data are entered:

Field	Meaning
Consent obtained	Positive confirmation that consent preceded study participation
Consent date/time	When consent was obtained
Consent form version	Approved consent version used at the site
Person obtaining consent	Investigator/delegated site staff reference
Participant/LAR basis	Participant or legally acceptable representative, as applicable
Evidence reference	Link/coordinate to the consent evidence; EDC need not own the document
Confirmed by/at	Accountable site user and EDC entry time

Consent Confirmation is not the consent process itself and does not replace the signed consent record. It is the safety gate that permits study-specific screening collection in EDC.

A screening attempt is proposed as a separate retained record because screen failure and rescreening must remain reconstructable.

Field	Meaning
Attempt number	Stable sequence for this subject/rescreen chain
Screening start	Date/time screening began
Informed-consent reference	Evidence coordinate, not the consent document itself
Eligibility assessment	Outcome and responsible investigator where captured in EDC
Outcome	Pending, passed, failed, withdrawn before decision
Failure date and reason	Coded and optional explanatory text
Related casebook	Collection record holding the screening CRFs

Whether a rescreen produces a new Subject or another Screening Attempt under one Subject is an open product decision. The model must never hide the relationship.

Casebook

The Casebook is the subject’s protocol-driven EDC collection record.

Field	Clinical meaning
Subject	One subject within one EDC study
Initial design assignment	Published design active at the site when screening began
Amendment history	Later design versions adopted and their effective evidence
Expected schedule	Visits/forms currently expected under the assigned design
Actual occurrences	Visits, forms, rows, and datapoints created during conduct
Conduct version	Changes whenever subject data or collection structure changes
Finalization version	Changes whenever prior review, signature, or lock evidence may become stale
Current controls	Freeze, signature, and lock status by scope

The casebook is normally created with the subject at screening. Waiting until enrollment would leave informed-consent, eligibility, screen-failure, and screening-assessment CRFs without a proper subject collection record.

Normal journey

Site active for EDC
→ Obtain informed consent outside or through the owning consent process
→ Confirm consent in EDC
→ Create Subject + Casebook under site's active design and start screening
→ Enter eligibility and other screening data
→ Screen failed OR enrolled
→ Randomized, if applicable and received from RTSM
→ On treatment / follow-up
→ Treatment discontinued, study withdrawn, lost to follow-up, completed, or died
→ Cleaning and finalization continue as required

Treatment discontinuation and study withdrawal are not synonyms. A subject may stop treatment and remain in survival or safety follow-up. Recording a disposition does not automatically prevent permitted late data entry, query response, review, or correction.

Actions

Action	Clinical result
Configure EDC site	Creates product-specific site participation
Confirm readiness	Records completed EDC prerequisites
Activate site	Permits new screening/casebook creation under one active design
Suspend/reactivate site	Stops/resumes new EDC conduct while retaining existing records
Assign new design for new casebooks	Changes prospective site assignment only
Confirm consent and start screening	Verifies consent evidence, then creates subject, initial screening attempt, casebook, and minimum schedule
Correct subject number	Retains stable identity and number history
Record screen failure	Completes attempt with date/reason; casebook remains retained
Confirm enrollment	Records eligibility/enrollment decision and date
Record external randomization	References an owner-published RTSM fact
Record subject disposition	Adds a dated clinical disposition fact
Add unscheduled event	Creates the next permitted occurrence under the assigned design
Adopt amendment	Moves one casebook through an assessed, traceable version transition

Business rules

A site cannot create a subject while not active for EDC, except through an explicitly authorized correction/recovery process.
Each subject number is unique within the study according to the approved numbering policy.
Correcting a subject number never changes the stable subject identity.
A subject has one active casebook per EDC study unless a reviewed scenario justifies otherwise.
The initial casebook records the site’s active Design Publication at screening time.
Later site-version changes affect new casebooks; existing casebooks require amendment adoption.
Screen failure never deletes the subject, screening CRFs, audit history, or queries.
Randomization received from RTSM is referenced as an external fact; EDC does not re-decide allocation.
Subject disposition history is append-only and corrections preserve prior facts.
Site suspension stops new conduct as policy declares but does not erase or make retained data inaccessible.
Closed or withdrawn subjects may still require query response, follow-up, coding, review, and signature.
Study-specific screening data cannot be entered until valid informed-consent confirmation is recorded, except data explicitly permitted before consent by approved study policy and applicable requirements.
Consent withdrawal stops future activity according to the recorded withdrawal scope and policy; it does not silently erase lawfully retained prior records.

Audit evidence

Retain who, when, authority, reason, effective time, prior state, next state, design assignment, and external evidence coordinates for every site activation, subject-number correction, screening outcome, enrollment decision, disposition change, transfer, and amendment adoption.

Exceptions requiring product decisions

Another system screens and numbers the participant before EDC receives the record.
A potential participant is assessed against non-identifying pre-screen criteria before consent; EDC must not treat this as an enrolled study Subject or collect prohibited study data.
Consent was obtained on paper while EDC was unavailable; later confirmation preserves actual consent time and later EDC entry time.
A screen-failed participant is rescreened at the same site.
A screen-failed participant is rescreened at another site.
A subject is enrolled before all screening forms are submitted under an approved override.
The site’s active design changes between screening start and enrollment.
A subject moves to another investigator site after data have been entered.
A duplicate subject is discovered after both records contain clinical data.
A subject withdraws consent for future collection while retained data remain required.
The site is suspended while urgent safety follow-up data must be reported.

Handoffs

Platform owns canonical Study Site identity and general access mechanisms.
Study Startup/CTMS may publish approval and activation milestones.
EDC owns whether and when the site is active for EDC.
RTSM owns randomization and treatment allocation.
Safety owns the safety-case decision even when EDC supplies adverse-event data.
eCOA owns participant-completed assessment occurrences and sends traceable results to EDC/data review.