EDC product decisions
How to use this ledger
Section titled “How to use this ledger”Settled proposal means the greenfield model takes the position unless product review reopens it. Open means implementation must not silently decide it. Deferred means the model records the pressure but does not add first-release behavior.
Settled proposals
Section titled “Settled proposals”| ID | Decision | Rationale |
|---|---|---|
| EDC-D01 | Create Subject and Casebook when screening starts | Screening CRFs are clinical data and need a versioned collection record before enrollment |
| EDC-D02 | Keep Subject and Casebook distinct | Subject identity/status and protocol collection have related but different meaning |
| EDC-D03 | Separate CRF, item-group, and item definitions from their placements | Reusable clinical meaning remains stable while contextual order, wording, repetition, requiredness and applicability belong to placements |
| EDC-D04 | Published designs cannot be changed and are self-contained | Subject-collection meaning must not drift with library changes |
| EDC-D05 | Existing casebooks adopt amendments explicitly | Site assignment for new casebooks cannot silently rewrite existing subjects |
| EDC-D06 | Preserve stable occurrence sequences | Historical references cannot change after deletion/inactivation of an earlier repeat |
| EDC-D07 | Blank, missing, unknown, not done, not applicable, and invalid are distinct | Each has different clinical and query meaning |
| EDC-D08 | Corrections create retained revisions | Original reported data must remain reconstructable |
| EDC-D09 | Edit-check finding and query are separate | Automated condition and accountable site conversation have different lifecycles |
| EDC-D10 | Review requirement and review evidence are separate | A plan does not prove work was completed |
| EDC-D11 | SDV, DMR, coding, and signature remain distinct | They answer different clinical questions |
| EDC-D12 | Coding never overwrites the site verbatim | Reported term and standardized interpretation are both required |
| EDC-D13 | Signature binds signer, attestation, scope, and exact data | A mutable signed flag is insufficient evidence |
| EDC-D14 | Freeze, scoped lock, database lock, and data cut are distinct | They permit different work and communicate different finality |
| EDC-D15 | Unlock creates reopen evidence; it does not delete a lock | Exceptional post-lock change must remain reconstructable |
| EDC-D16 | Standards exchange structures remain mappings | ODM/CDASH/SDTM inform interoperability and collection but do not dictate internal ownership |
| EDC-D17 | Informed consent precedes study-specific screening collection | Consent confirmation is the safety gate for creating the screening casebook and entering screening data |
| EDC-D18 | Datapoint identity uses the subject occurrence and Item Placement | Compatible amendment adoption must not create a new identity for the same collected question |
| EDC-D19 | Visit display, applicability, schedule, availability and completion are independent | Each answers a different operational question |
| EDC-D20 | Publication, site assignment and casebook adoption are separate | Making a design available is not the same as selecting it for new or existing casebooks |
| EDC-D21 | Query cancellation differs from closure | Cancellation records error/duplication/obsolescence; closure records clinical disposition |
| EDC-D22 | Whole-study final-analysis lock is the included Database Lock | Subset control uses Scoped Lock or Data Cut; partial database lock is deferred |
| EDC-D23 | EDC detects potential deviations but does not own final deviation assessment | The owning deviation-management process classifies, assesses and disposes the candidate |
| EDC-D24 | Review, coding, and signature plans own independent approved versions and assignments | Operational plan change must not rewrite a published CRF design or completed evidence |
| EDC-D25 | Coding Request, Coding Decision, Coding Review, and dictionary-change assessment have separate journeys | Clarification, assignment, approval, and remapping are different accountable actions |
| EDC-D26 | Each expected investigator endorsement has a Signature Requirement | The requirement can be due, ready, satisfied, superseded, or exceptionally waived independently of the signature evidence |
Open — subject and site conduct
Section titled “Open — subject and site conduct”| ID | Product question | Options/impact |
|---|---|---|
| EDC-Q01 | Does rescreening create a new Subject or another Screening Attempt? | Must support site operations while preserving linkage and privacy |
| EDC-Q02 | Can one person be rescreened at a different site? | Affects subject numbering, identity matching, and site visibility |
| EDC-Q03 | Are subject transfers supported? | Requires historical/current site responsibility, authority, and query ownership |
| EDC-Q04 | May another system create the screening identity before EDC? | Requires an explicit import/create-casebook contract and duplicate policy |
| EDC-Q05 | Can a subject enroll with incomplete screening forms under override? | Requires accountable investigator decision and evidence |
| EDC-Q06 | Which dispositions close future collection versus only treatment? | Must be protocol-configurable without conflating withdrawal types |
Open — design and collection
Section titled “Open — design and collection”| ID | Product question | Options/impact |
|---|---|---|
| EDC-Q07 | Which reusable standards-library capabilities are Core? | Full governance library versus study-local reuse only |
| EDC-Q08 | Which partial dates/times are supported by item type? | Affects entry, checks, schedules, derivations, and exports |
| EDC-Q09 | What happens to open visit windows when an anchor is corrected? | Recalculate, preserve after opening, or configurable by rule |
| EDC-Q10 | Which dynamic-removal conflicts can be resolved automatically? | Blank-only removal is safe proposal; nonblank data require deliberate disposition |
| EDC-Q11 | Are repeat maxima hard limits or overrideable clinical warnings? | Affects unexpected treatment cycles and logs |
| EDC-Q12 | Which design changes may be applied without a new casebook version? | Rule/review-plan changes still need evidence and reconciliation even when visits, forms, and items do not change |
Open — data and queries
Section titled “Open — data and queries”| ID | Product question | Options/impact |
|---|---|---|
| EDC-Q13 | What is the governed missing-reason codelist at item, row, form, and event level? | Must balance protocol specificity and consistent reporting |
| EDC-Q14 | Which invalid input attempts are retained? | Regulated evidence versus transient usability assistance |
| EDC-Q15 | Can sponsor staff directly correct site-entered data? | Recommended only through exceptional, pre-agreed controlled process |
| EDC-Q16 | When may system queries auto-close? | On passing recheck, on data correction, never, or study-configurable |
| EDC-Q17 | How are equivalent automatic/manual queries prevented or linked? | Avoids duplicate site burden without losing different review intent |
| EDC-Q18 | Does EDC own queries on external data? | Depends on whether the site or external provider is accountable for resolution |
| EDC-Q18A | What are query routing, due-date and escalation policies by query category? | Required for accountable worklists without changing clinical query meaning |
Open — review, coding, and signature
Section titled “Open — review, coding, and signature”| ID | Product question | Options/impact |
|---|---|---|
| EDC-Q19 | What is the authoritative SDV grain? | Item-level evidence with form roll-up is the proposed default |
| EDC-Q20 | What is the authoritative DMR grain? | Item, form revision set, listing row, or named review objective |
| EDC-Q21 | Which changes are immaterial to completed review? | Requires explicit change classification; never hidden checkmark clearing |
| EDC-Q22 | Is coding approval required? | All manual/autocoded decisions, selected studies, or none |
| EDC-Q23 | How are dictionary up-versions authorized and reviewed? | Study-wide plan, remap evidence, noncurrent disposition |
| EDC-Q24 | Which milestones require PI signature? | Form, event, periodic casebook, interim, and final possibilities |
| EDC-Q25 | What exact data changes require re-signature? | Must consider source/context, derived values, added forms, and masked data |
| EDC-Q25A | May a Signature Requirement be waived, and by whom? | Requires narrow exception reasons and retained authority/evidence |
Open — lock and delivery
Section titled “Open — lock and delivery”| ID | Product question | Options/impact |
|---|---|---|
| EDC-Q26 | What work is allowed under freeze and under scoped lock? | Queries, SDV, DMR, coding, signing, and exports need explicit matrix |
| EDC-Q27 | What is the smallest reopen scope? | Datapoint, form, event, casebook, site, or whole database |
| EDC-Q28 | What constitutes database-lock readiness? | Exact required forms, queries, reviews, coding, reconciliation, signatures, and deviations |
| EDC-Q29 | Who may approve lock exceptions and post-lock reopen? | Requires role and dual-approval policy appropriate to risk |
| EDC-Q30 | Should a future partial database-lock product exist? | Deferred; current model uses Scoped Locks and reproducible Data Cuts |
| EDC-Q31 | What is the authoritative locked-study delivery? | Raw data, ODM/archive package, audit package, or defined bundle |
| EDC-Q32 | What constitutes the investigator’s independent retained casebook copy? | Format, timing, audit/signature content, availability, and certification |
Deferred extension pressures
Section titled “Deferred extension pressures”- adaptive-treatment schedules driven by unblinded data;
- cross-study subject identity;
- multiple concurrent casebooks for one subject in one study;
- fully offline site entry and bidirectional merge;
- image/audio/video as first-class CRF values;
- adjudication committee workflow;
- comprehensive laboratory reference-range management; and
- statistical analysis and SDTM transformation ownership.
Deferred does not mean impossible. It prevents unreviewed complexity from entering the Core model.
Acceptance record required
Section titled “Acceptance record required”For every open decision, product review should record selected interpretation, clinical rationale, affected records/actions/rules, evidence expectations, scenarios, rejected alternatives, and whether the decision changes the Core concept set.