Let's Start With the Study at a Glance

• Protocol ID / study name and therapeutic area (brief)
• Which phase best describes this study? Options: Phase I, Phase II, Phase III, Phase IV, Hybrid / adaptive, Other
• What is your target database lock date and the regulatory milestone tied to it (e.g., first patient last visit, NDA/BLA filing date)?
• What is the primary submission type or regulatory pathway you are planning for this program? Options: NDA/BLA, MAA/European filing, IDE, PM/510(k), No regulatory filing planned, Other
• Approximate planned enrollment and number of sites (or range)
• Who on your team will be the day-to-day contact for clinical data management activities? (Select all that apply) Options: Director of Clinical Data Management, Head of Biometrics / Biostatistics, VP Clinical Operations, Study Project Manager, Clinical Program Lead, Vendor PM, Other
• What single outcome would make you say this study’s data management was a clear success?

What Keeps You Up at Night About Getting to Lock?

• Given your timelines, where is the single biggest risk to hitting database lock on time? Options: Query backlog, External data integration, Site data entry delays, CRF/design issues, Insufficient resourcing, Regulatory questions, Other
• How often have your last 2–3 studies missed the planned lock date? Options: Never, Once, Occasionally (some studies), Often (many studies), Always / chronic delays
• When delays happened previously, what were the top two root causes? (pick up to two) Options: Slow query resolution, Late external labs/imaging, Poor edit checks (false positives), CRF changes mid-study, Vendor integration failures, Insufficient sponsor review capacity, Other
• When these issues occur, how does it usually feel for your team—annoying but manageable, frantic, or paralyzing? Give a short example.
• How much schedule cushion (weeks) do you typically have between anticipated database lock and your submission deadline? Options: >12 weeks, 8–12 weeks, 4–8 weeks, 2–4 weeks, <2 weeks / none

Where Do Your Data Break Down—Honestly?

• Which external data source causes the most rework when you try to assemble the analysis dataset? Options: Central labs, Imaging/Central reads, ePRO / patient reported, Safety / pharmacovigilance, IVRS/IWRS, Wearables, Other
• Describe a recent example where integrating an external feed introduced unexpected work—what happened and how long did it add to your timeline?
• How are reconciliations between EDC and external sources currently performed? Options: Automated reconciliations with rules, Manual reconciliation by data manager, Hybrid (semi-automated), We don’t perform formal reconciliations, Other
• Who is accountable for resolving inconsistencies between EDC and external data (role/title)? Options: Sponsor CDM, Biostatistics, Vendor data services, Clinical operations, Site, Other
• Which data element types typically require the most manual intervention (select all that apply)? Options: Lab results, Imaging measurements, Concomitant meds, Adverse events / MedDRA coding, ePRO timestamps, PK/PD values, Other

Are Your Edit‑Checks Helping or Hurting?

• If your edit‑check suite ran a reality check, what proportion are true positives versus noisy false positives? Options: Mostly true positives, Balanced, Mostly false positives/noisy, We don’t measure this
• Which edit‑check types do you rely on most to surface real issues? (choose up to three) Options: Range/limits, Cross-form consistency, Visit-window enforcement, Required-field checks, Date logic, Complex algorithmic checks, Other
• Who owns edit‑check logic changes mid-study, and how are those decisions tracked? Options: Sponsor CDM, Sponsor Biostatistics, Vendor build team, Change control board, No formal owner
• How quickly can your team implement and validate a critical edit‑check change (business days)? Options: Same day, 1–3 days, 4–7 days, More than 7 days, Variable / unknown
• Tell us about a time an edit‑check caused unexpected downstream work—what was the check, and how would you have designed it differently?

Who’s In The Room When Decisions Matter?

• If we mapped all approvers needed for lock, whose sign‑off has historically delayed decisions? Options: Biostatistics, Medical Monitor / Clin Ops, Regulatory Affairs, Quality Assurance, External vendors, Executive sponsor, Other
• Who specifically has final sign‑off authority for database lock on this program (name or role)?
• What is the agreed escalation path when a dispute about data readiness occurs? Options: Project Steering Committee, Sponsor QA, Regulatory lead, Executive sponsor, Ad hoc working group, No formal path
• How available are key decision-makers during the 8 weeks before planned lock? Options: Fully available, Mostly available, Partially available / limited, Often unavailable, Unknown
• Are there external stakeholders (CROs, labs, imaging centers) who must also sign off before lock? If yes, list them and their sign-off dependencies.

What Exact Signals Would Let You Say 'Lock' Confidently?

• What quantitative thresholds would make you comfortable signing off (e.g., query backlog, outstanding edit‑checks, SDTM/CDISC readiness)? Please be specific.
• Which of these acceptance criteria are non‑negotiable for your team? Options: Zero critical queries, Query backlog < X items (specify), CDISC datasets validated, Audit trail complete, All external reconciliations closed, Edit‑check pass rate threshold
• Who performs the final technical verification of CDISC/ADaM deliverables on your side? Options: Sponsor Biostatistics, In‑house SDTM team, External statistics vendor, Vendor services team, Other
• How do you want evidence presented for each acceptance criterion (dashboards, exported reports, annotated listings, audit log snapshots)? Options: Interactive dashboard, PDF reports, CSV/Excel exports, Annotated listings, Access to raw audit trail, Other
• How much time do you require to review final acceptance artifacts before you can sign (days)? Options: Same day, 1–3 days, 4–7 days, More than 7 days

If We Could Remove One Roadblock, What Would It Be?

• Which vendor capability would change the odds of on‑time lock the most for you? Options: Faster study build, Stronger external integrations, Dedicated data manager support, Advanced edit‑check tuning, Automation for reconciliations, Regulatory evidence packaging
• How do you feel about the balance of technology vs. human services in past vendor relationships—too much tech, too much hands‑on, or about right? Options: Too much technology (insufficient service), Too much service (manual), Balanced, Depends on the study
• Give a concrete example of the best vendor support you've received—what did they do that mattered?
• What would an ideal trial readiness package from a vendor include for this program (pick up to three)? Options: Prebuilt CRFs / CDASH templates, Integration connectors to our labs/imaging, Edit‑check library tuned to indication, Dedicated data manager(s), Prevalidated CDISC mappings, Regulatory packaging support
• What concerns would make you hesitant to hand over parts of data management to a vendor?

Timing, Constraints, and Non‑Negotiables

• Which single external constraint would stop this submission cold if not satisfied (e.g., lab accreditation, imaging read timeliness, site activation delays)?
• Are there blackout windows or hard freezes on changes due to regulatory committee calendars or sponsor events? Options: Yes — specify windows, No, Unsure
• Do you have fixed SLAs for external data (lab turnaround, imaging reads) that vendors must meet? If yes, list them.
• What is the maximum acceptable number of outstanding queries at lock (if any)? Options: 0 (no outstanding queries), 1–10, 11–50, 51–200, No hard limit specified
• What cadence of status updates and artifacts would you prefer in the 12 weeks before lock? Options: Daily dashboard + weekly review, Weekly dashboard + biweekly meeting, Twice monthly updates, Monthly only, Ad hoc as needed

Quick Wins & Next Steps — What Would Help Right Now?

• If you had 60 days to improve probability of on‑time lock, what one change would you prioritize?
• Would you be open to a short technical proof‑of‑concept using a subset of your data to prove integrations and CDISC mapping? Options: Yes — sample data available, Yes — but need NDA/contract first, Not at this time, Maybe — need more info
• Can you provide a small sample of the external feeds we need to integrate (labs, imaging, ePRO) for an initial test? If not, what blocks sharing? Options: Yes — ready, Requires data‑sharing agreement, Governance/privacy blocks, Unable to share anything
• Who should we schedule for a 60‑minute technical alignment call to make immediate progress (name/role and best contact method)?
• Finally, how would you prefer we present a quick proposal of next steps: an executive one‑pager, a technical runbook, or a combined timeline + cost estimate? Options: Executive one‑pager, Technical runbook, Combined timeline + cost estimate, All three

• Solution Experience Intake & Current State Alignment
• Scenario Mapping Workshop — Walk the Study with Real Records
• Integration & Reconciliation Deep Dive
• Edit‑Check, Query Management & Lock Acceptance Criteria Workshop
• Executive Validation & Mutual Commit

• Define the artifact set required for formal sign‑off (datasets, reconciliation logs, audit trail reports).
• Show direct proof that platform processes deliver the defined future state for each prioritized scenario.
• Tie each demonstrated change back to the customer's stated consequences (time, cost, risk).
• Obtain explicit customer validation or clarification for each scenario's outcome.
• Identify remaining gaps and owners to close them before integration work.
• Vendor: Produce a scenario playbook that documents steps taken, screenshots/log extracts, and quantified benefits for each exercised scenario.
• Customer: Confirm validated scenarios in writing and list any deviations from expected outcomes.
• Both: Agree owners and deadlines for resolving any unresolved issues from the workshop.
• Current Integration Landscape
• Agree field-level mapping and CDISC assembly approach for key external sources.
• Define a reconciliation process that produces a single source of truth and measurable exception handling SLAs.
• Set responsibilities, timelines, and validation tests for integration acceptance.
• Vendor: Deliver an integration specification and ETL mapping document for each external source within 5 business days.
• Customer: Provide API endpoints, data dictionaries, and sample extracts for systems not yet delivered.
• Both: Schedule an integration smoke test window and assign owners for remediation actions.
• Review Edit‑Check Backlog & Failure Modes
• Establish a clear, measurable acceptance checklist for database lock tied to specific edit‑checks and dataset tests.
• Agree query resolution SLAs and owners so backlog will be reduced according to timeline needs.
• Introductions & Objectives
• Vendor: Draft the edit‑check trace matrix mapping checks to lock acceptance criteria.
• Customer: Approve severity thresholds and provide preferred sign‑off approvers and template.
• Both: Schedule UAT window for edit‑check validation and assign remediation owners.
• One‑Sentence Current State & Consequence Recap
• Get executive confirmation that the platform proofs materially reduce the quantified consequences.
• Secure mutual commitments on resources, timelines, and acceptance criteria required to proceed.
• Agree the immediate next milestones (SOW, deployment readiness, UAT) and responsible owners.
• Vendor: Produce an executive summary with scenario proofs, quantified benefits, and a proposed timeline to lock.
• Both: Finalize and sign mutual commitments (SOW or MOU) specifying deliverables, SLAs, and acceptance criteria.
• Customer: Confirm internal approvers and allocate required resourcing for build and UAT windows.
• Have a single-sentence current state agreed by both parties.
• Surface and quantify the consequence of current failures to create urgency.
• Agree and schedule artifacts (sample data, CRF, integration specs) required for scenario mapping.
• Identify decision-makers and validation checkpoints for subsequent sessions.
• Customer: Deliver de-identified sample dataset, CRF, edit-check backlog, and query metrics within 3 business days.
• Vendor: Prepare an initial single-sentence current state summary and a risk/consequence spreadsheet.
• Both: Confirm 2–3 priority real-world scenarios to be exercised in the Scenario Mapping Workshop.
• Recap Intake Outputs
• Data Mapping & CDISC Strategy
• Edit‑Check Philosophy & Severity Definitions
• Highlights of Scenario Proofs
• One‑Sentence Current State
• Select & Prioritize Scenarios
• Scenario Step 1 — Current Handling
• Consequence Quantification
• Reconciliation Process & Tolerances
• Proposed Future State & Timeline to Lock
• Map Edit‑Checks to Acceptance Criteria
• Required Inputs & Pre‑work Review
• Risks, Mitigations & SLAs
• Scenario Step 2 — Platform Walkthrough with Sample Records
• Live Example: Reconciliation Run
• Query Management Workflow & SLAs
• CDISC/Analysis Dataset Readiness Checklist
• Scenario Step 3 — Proof of Future State
• Mutual Commitments & Decision Points
• Ownership, SLAs & Error Escalation
• Decision Criteria & Stakeholders
• Validation & Sign‑Off Process
• Confirm Next Steps & Validation Points
• Tie Back to Consequence

• EDC CRF Design and Study Build
• Edit Check Programming and Deployment
• Site User Training and eLearning Delivery
• Site Data Entry Support and Helpdesk
• Query Generation and Resolution Management
• Medical Coding (MedDRA/WHO Drug) and QC
• Central Lab Data Integration and Reconciliation
• Imaging (DICOM) Data Ingestion and Linkage
• ePRO Integration and Data Synchronization
• Safety/Pharmacovigilance Data Reconciliation
• Data Cleaning and Discrepancy Closure to Lock
• Derive and Deliver CDISC SDTM/ADaM Datasets
• Interim Analysis-Ready Data Extracts
• Database Lock and Regulatory Submission Package

EDC CRF Design and Study Build

• What phase(s) is the study (this affects CRF complexity and build scope)? Options: Phase I, Phase II, Phase III, Phase IV, Device/Other
• How many sites and anticipated active subjects will the EDC need to support? Options: Single-site, 2-10 sites, 11-100 sites, 100+ sites
• How would you classify the visit schedule and form complexity? Options: Simple (fixed visits, few forms), Moderate (conditional fields, branching), Complex (adaptive visits, many conditional branches)
• Which EDC features are required during build (select all that apply)? Options: eSource, Conditional branching/skip logic, Complex scheduling (windowing), Electronic signatures (21 CFR Part 11), Custom calculated fields, Local language / translations
• Who is the primary owner of CRF design and source documentation? Options: Sponsor, Vendor, Shared (Sponsor + Vendor)
• Describe any non-standard CRF elements, custom validations, or external mappings needed (free text)

Edit Check Programming and Deployment

• Approximately how many edit checks are expected for the study? Options: <50, 50-200, 200-500, 500+
• Which types of edit checks are required (select all that apply)? Options: Real-time single-field, Cross-form/composite, Date/sequencing, Logic consistency (medicalRules), Range/outlier detection, Batch/offline checks
• Do you require severity tiers and triage rules for edit check results? Options: Yes, No
• Who will author and approve the edit check specifications? Options: Sponsor, Vendor, Sponsor review of Vendor specs
• What is your preferred deployment cadence for edit checks (e.g., only pre-launch, iterative during UAT/production)? Options: Pre-launch only, Iterative during UAT, Frequent updates during live, Ad-hoc/as needed
• List any specific acceptance criteria for edit checks (e.g., false positive rate, performance SLAs)

Site User Training and eLearning Delivery

• How many distinct site user roles require training (e.g., CRC, PI, data entry)? Options: 1-2, 3-5, 6-10, 10+
• Which training delivery methods do you want (select all that apply)? Options: Live webinars, On-site training, Self-paced eLearning / LMS, Train-the-trainer, Quick reference guides / job aids
• Do you require an LMS with completion tracking and certificates? Options: Yes, No
• Will content need localization or multi-language support? If yes, list languages. Options: Single language (English), Multiple languages (specify below)
• When should site training occur relative to UAT and go-live? Options: Before UAT, After UAT / Pre-go-live, At go-live, Staggered by region
• Any site groups with special training needs (e.g., low IT literacy, pediatric sites)? Describe.

Site Data Entry Support and Helpdesk

• What support hours are required for site helpdesk coverage? Options: 24/7, Regional business hours, Sponsor business hours only, Hybrid (regional coverage)
• Which support channels should be provided (select all that apply)? Options: Phone, Email, Chat, Ticketing portal, Remote screenshare
• What SLA targets do you expect for initial response and resolution? Options: Initial response <1 hour, Initial response 1-4 hours, Initial response 24 hours, Resolution target 24-72 hours
• Do you require tiered support levels (L1/L2/L3) with escalation paths? Options: Yes, No
• Estimate expected ticket volume at peak (per week). Options: <10, 10-50, 51-200, 200+
• Are there existing site support contacts or portals we must integrate with? Provide details.

Query Generation and Resolution Management

• Who will own query management workflows and final resolution authority? Options: Sponsor, Vendor, Shared (Sponsor oversight)
• What are acceptable target turnaround times for query resolution? Options: 24 hours, 48 hours, 72 hours, 7 days
• Do you want automated query escalation rules and aging alerts? Options: Yes, No
• Should query generation be automatic from edit checks only, or also manual from monitors/CRAs? Options: Automated only, Automated + Manual
• Do you require dashboarding and regular reports for query backlog and metrics? Options: Yes, No
• Any specific acceptance criteria for query resolution (e.g., percent closed within SLA, median time)?

Medical Coding (MedDRA/WHO Drug) and QC

• Which coding dictionaries are required for the study? Options: MedDRA, WHO Drug, Other (specify)
• Desired coding approach: Options: Automatic (auto-code majority), Manual coding for all terms, Hybrid (auto + manual review)
• Who will provide preferred dictionary versions and maintenance (Sponsor vs Vendor)? Options: Sponsor provides versions, Vendor manages versions, Specify version below
• What QC sampling or double-coding rate do you require for safety/reaction terms? Options: 100% QC, 25% QC sample, 10% QC sample, Custom
• Are there therapeutic area-specific coding rules or sponsor conventions to apply? Provide details.

Central Lab Data Integration and Reconciliation

• Which central lab data formats and standards will be used? Options: HL7/ODM, CSV/flat files, Vendor proprietary, Other
• What is the expected feed frequency from the lab (select primary)? Options: Real-time, Daily batch, Weekly, On-demand
• Who will own mapping and data transformation rules for lab variables? Options: Sponsor, Vendor, Shared
• Do you require unit normalization and reference range alignment across labs? Options: Yes, No
• Describe reconciliation rules between EDC and lab (e.g., specimen ID matching, visit window tolerance).

Imaging (DICOM) Data Ingestion and Linkage

• What imaging transfer mechanisms are planned (select all that apply)? Options: SFTP, API, Vendor portal / DICOM router, Physical media (rare)
• Is de-identification/pseudonymization of DICOM files required before ingestion? Options: Yes, No
• How should images be linked to subjects/visits (e.g., subject ID + visit number, accession no.)? Options: Subject ID + Visit, Accession/Study ID, Other (specify)
• Estimate imaging volume (studies per month) and any large file size considerations. Options: Low (<50/month), Moderate (50-500/month), High (500+/month)
• Any special processing required (QC, anonymization, DICOM to derived images)? Provide details.

ePRO Integration and Data Synchronization

• Which ePRO vendor(s) will be used? Options: Vendor A, Vendor B, Sponsor provided, Other (specify)
• What synchronization frequency do you require between ePRO and EDC? Options: Real-time, Daily batch, Weekly, Per visit sync
• Do you require device provisioning and user management for ePRO devices? Options: Yes, No
• How should missing or late ePRO data be handled for analysis readiness? Options: Flag and query, Imputation plan, Sponsor will instruct
• Are timezone handling and timestamp normalization required for ePRO timestamps? Options: Yes, No

Safety/Pharmacovigilance Data Reconciliation

• Which safety/PV system is the study using (select all that apply)? Options: Argus, ArisG, Other PV system, No PV system yet
• What cadence is required for safety data reconciliation between EDC and PV? Options: Real-time, Daily, Weekly, On-demand
• Should SAE/Expedited events be routed automatically to PV with eCRF triggers? Options: Yes (automatic), No (manual handoff)
• Who is responsible for final SAE reconciliation and sign-off? Options: Sponsor PV, Vendor PV team, Shared
• Any country-specific expedited reporting requirements we should account for? If yes, describe.

Data Cleaning and Discrepancy Closure to Lock

• Who will have primary responsibility for day-to-day data cleaning? Options: Sponsor CDM team, Vendor data management, Hybrid/resourced shared model
• What is your target timeline from last patient last visit (LPLV) to database lock? Options: <2 weeks, 2-4 weeks, 1-3 months, 3+ months
• What acceptance criteria define 'clean' for lock (e.g., query backlog, open critical queries=0)?
• Do you require reconciliation artifacts and documented sign-offs for each lockable dataset? Options: Yes, No
• Are there special handling rules for outliers, missing critical fields, or protocol deviations before lock? Options: Yes - specify below, No

• Non-Disclosure Agreement (NDA)
• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Service Level Agreement (SLA)
• Pricing & Payment Schedule
• Resourcing & Staffing Plan
• Project Timeline & Milestones
• Regulatory Acceptance Criteria Addendum
• Data Processing & Security Agreement (DPA)
• Integration & Data Transfer Agreement
• Acceptance Criteria & Sign-off Matrix
• Change Control & Change Order Procedure
• Termination & Exit Plan
• Insurance, Indemnity & Liability

• Success Outcomes Review & Acceptance
• Lessons Learned & Continuous Improvement Workshop
• Enhancement Backlog Review & Prioritization
• Operational Handoff & Shared Channel Governance
• Regulatory Evidence & Filing Safeguard Review

• Publish SLA document and escalation matrix within the channel and email distribution list.
• Define acceptance criteria, owners, and tentative delivery windows for prioritized items.
• Ensure transparency in how enhancements are communicated and controlled for active studies.
• Record prioritized backlog into the product/implementation tracker with owners and target release windows.
• Create detailed acceptance criteria and test cases for top priority items.
• Update the shared channel/roadmap to reflect agreed priorities and timelines.
• Assess need for change control documentation for any live-study-impacting changes.
• Support Model & SLA Review
• Create an active shared channel with governance rules and access for the sponsor and vendor teams.
• Agree SLAs and escalation paths to protect timelines and filing dates.
• Establish monitoring cadence and documentation ownership for ongoing operations.
• Provision shared channel, invite required participants, and apply agreed governance settings.
• Introductions & Objectives
• Schedule recurring health-check meetings (weekly ops, monthly exec) and prepare initial dashboard.
• Upload runbooks, user guides, and handoff materials to the agreed repository and link in the channel.
• Regulatory Acceptance Criteria Recap
• Confirm the regulatory evidence package is complete or document exactly what is outstanding.
• Agree mitigation steps and owners for any residual regulatory risks to the filing.
• Establish contingency triggers and the escalation path to protect the filing date.
• Deliver final regulatory evidence package (or updated index) to sponsor regulatory leads and archive in shared channel.
• Create and assign mitigation tasks for each outstanding regulatory item with target completion dates.
• Document contingency triggers and escalation steps; circulate to executive sponsors.
• Confirm and calendar the final sign-off meeting with required approvers.
• Mutually confirm which success signals are met and which require remediation.
• Obtain formal acceptance or document conditional acceptance criteria and owners.
• Agree remediation plans with owners and timelines for any outstanding items.
• Publish acceptance artifacts and evidence into the shared channel for auditability.
• Produce formal acceptance sign-off document and collect sponsor signatures.
• Create remediation plan(s) for any unmet signals with owners, due dates, and verification steps.
• Upload evidence pack and acceptance artifacts to the agreed shared channel.
• Schedule follow-up verification meeting for conditional acceptances.
• Workshop Purpose & Ground Rules
• Establish a shared, evidence‑based set of lessons learned (facts and root causes).
• Agree on 3–5 priority process or tooling changes with owners and deadlines.
• Create measurable success metrics to validate improvements on subsequent studies.
• Publish a concise Lessons Learned report with root causes, evidence, and recommended mitigations.
• Create process-change tickets (or project epics) for prioritized improvements with owners and due dates.
• Schedule a quarterly review to check progress on improvements and validate impact metrics.
• Document and share 'what worked' checklists for reuse on future studies.
• Backlog Overview
• Agree a prioritized enhancement backlog aligned to filing risk and operational value.
• Impact & Effort Scoring
• Evidence Package Walkthrough
• Shared Channel Setup & Governance
• Timeline & Fact Review
• Success Signals Summary
• Prioritization & Roadmap Windowing
• Evidence Walkthrough
• Outstanding Risks & Mitigations
• Root Cause Analysis
• Escalation Matrix & Contacts
• Monitoring, Reporting & Health Checks
• What Worked Well
• Contingency Triggers & Escalation
• Gaps, Exceptions & Impact
• Acceptance Criteria & Test Strategy
• Final Sign-off Path & Timeline
• Communication & Change Control
• Acceptance Decision & Criteria
• Improvement Opportunities & Prioritization