Veeva Vault

Vendor: Veeva Systems · Enterprise

Veeva Vault is a cloud platform for life sciences that manages regulated documents and the data about them in one place, so a document's content and its business context (which trial, which country, which site, which milestone) never drift apart. It is used across the drug development lifecycle, and this entry covers its clinical operations applications: Vault eTMF, which holds the Trial Master File - the regulator-mandated evidence file for a clinical trial - and Vault Study Startup, which drives sites from selection to activation. Every document runs a configurable lifecycle and every change is written to an audit trail, which is what makes the platform readable as an event log.

Study Start-up (STUDY_STARTUP)

Bringing a clinical trial site from identification to activation: feasibility and selection, qualification document collection, clinical trial agreement negotiation, ethics committee submission and approval, regulatory notification, and the document completeness that gates activation.

Activities

Create Study Site Record - A study_site__v record is created under its study country. Creation appears in object_audit_trail and starts the site's start-up clock.
Apply Country Start-up Template - A country template is applied, bringing the document types, template milestones, dependencies and expected documents that country's regulator requires.
Generate Milestones from Template - milestone__v records are created in bulk from milestone_template__v, together with milestone_dependency__v records that set the planned precedence.
Generate Expected Documents - EDL and EDL Item records are created in bulk from templates against the new milestones, defining what must be collected before the site can be activated.
Conduct Site Feasibility Assessment - Feasibility and site selection records and their documents are captured against the site, evidenced by site selection artifacts reaching steady state.
Collect Site Qualification Documents - Investigator CVs, training records, financial disclosures and licences are uploaded against study_person__clin records and matched to their expected documents.
Negotiate Clinical Trial Agreement - Contract versions cycle between sponsor and site. Each version and state change is recorded in document_audit_trail, which is what makes negotiation rounds countable.
Execute Clinical Trial Agreement - The executed agreement reaches steady state against its expected document, releasing the contract dependency.
Submit to Ethics Committee - The ethics or IRB submission package is issued and the submission recorded, typically as a milestone state change with its actual date.
Respond to Ethics Questions - Questions raised by the committee produce a further submission cycle. Repeated submissions against one site are the resubmission loop.
Record Ethics Approval - The approval document reaches steady state and the corresponding milestone completes.
Complete Regulatory Notification - Where the country requires it, a ctn__v clinical trial notification is submitted and its state advanced.
Chase Outstanding Expected Documents - Activation is blocked while required EDL Items remain unmatched. Chasing cycles show as repeated checks against an incomplete expected-document set.
Activate Site - The study_site__v lifecycle state changes to activated, and its activation milestone completes with an actual date. This is the end of the start-up case.
Transfer Start-up Content to eTMF - Start-up content is filed into the trial master file, where it continues its life under the TMF process.

Case attributes

Site Name (string) - Site name from name__v.
Study Site ID (string) - The study_site__v record id. The case id when the case is one site being started up.
Cycle Time (decimal) - Elapsed time between two milestone points, from cycle_time__v.
Ethics Submission Count (integer) - How many times the site was submitted to its ethics committee, counting resubmissions.
Outstanding Expected Documents (integer) - EDL Items still unmatched for the site's activation milestone.
Managing CRO (string) - Contract research organisation managing the site, from study_organization__v.
Site Organization (string) - Organization operating the site, from the site's organization field.
Study (string) - Parent study from study__v.
Study Country (string) - Parent study country from study_country__v.
Principal Investigator (string) - Investigator designated through the Study Person team role.
Country Template Applied (string) - Which country start-up template drove the plan.
Site Lifecycle State (string) - Current state of the site record. Activation is a change of this field.
Activation Milestone Actual Date (date) - Actual date the activation milestone completed.
Activation Milestone Planned Date (date) - Planned date of the site activation milestone. The baseline for lateness.

Process-mining benefits (historical)

Where site activation time actually goes [Efficiency]: Break the elapsed time from site record creation to activation into its real segments - feasibility, contract, ethics, document collection - and see which one carries the delay. Teams usually assume it is ethics; the event log frequently says it is contracting or document chasing.
How many ethics resubmissions each country really needs [Efficiency]: Count how often a site went back to its ethics committee before approval. Repeated submissions are a country-level and sometimes a template-level problem, and they are invisible in a plan that shows only the final approval date.
Contract negotiation rounds by site and by CRO [Cost]: Each agreement version and state change is recorded, so negotiation rounds are countable. Comparing rounds across sites and across the organisations managing them shows where the standard contract is not fit for purpose.
Which start-up paths deviate from the country template [Compliance]: The country template defines the intended sequence and the milestone dependencies define the intended precedence. Comparing the discovered path against that plan shows which sites skipped, reordered or invented steps, and whether those sites activated faster or slower.
The document chase that blocks activation [Efficiency]: Sites are often ready except for a handful of qualification documents. Mining which expected documents are last to arrive, by country and by site, identifies the specific artifacts worth pre-collecting on the next trial.
Sites that were activated but never performed [Cost]: Comparing start-up effort against what a site went on to contribute shows where selection is going wrong. The expensive failure is not a slow site, it is a site that consumed a full start-up cycle and then enrolled nobody.

Process-mining benefits (action)

A live worklist of sites past their activation plan [Service]: Rank sites whose activation milestone has passed its planned date and is still open, so the start-up team works the sites that are actually slipping rather than the whole portfolio.
Alert when a site stalls between start-up steps [Efficiency]: Trigger when a site has sat between two start-up activities longer than your own threshold - contract sent but not returned, submission made but no response logged. Stalls are silent, and the sooner they surface the cheaper they are.
Chase the specific documents blocking each activation [Service]: Turn unmatched expected documents into a per-site chase list naming the exact artifact and the person it is owed by, instead of a completeness percentage nobody can act on.
Warn before a resubmission cycle repeats [Compliance]: When a site is heading into a second or third ethics submission, flag it early with what the previous round was queried on, so the same gap is not submitted twice.
Give each CRO a live view of the sites it is late on [Cost]: Where sites are managed by different organisations, a per-organisation view of open, late and blocked activations makes oversight a standing conversation rather than a monthly report.
Forecast activation dates from what actually happened [Service]: Use the observed durations of each start-up segment, by country, to project realistic activation dates for sites still in flight, and flag the ones whose plan is no longer credible.

Data tables

document_audit_trail - The document audit trail: every create, edit, state change, workflow task and view against a document, with who and when. This is the primary event source for mining a TMF document lifecycle.
documents - Vault document metadata: one row per document, with its classification against the TMF Reference Model and its links to study, country, site and milestone. Reached at /api/{version}/objects/documents and queryable with VQL.
edl__v - Expected Document List: the checklist of trial records expected, and explicitly not expected, at a given level of the study hierarchy.
edl_item__v - EDL Item, labelled Expected Document in most Vaults: one expected record, its requiredness, how many are expected, and how complete it is. The gap between an EDL Item and a matched document is what TMF completeness measures.
milestone__v - Milestone: a planned point in the trial that a set of expected documents belongs to. Milestone completion is the deadline TMF timeliness is measured against.
object_audit_trail - The object audit trail: the same history for object records rather than documents. Carries milestone, EDL item, site and quality issue state changes.
study__v - Study: the top of the clinical hierarchy. Groups all study-related data in the Vault.
study_country__v - Study Country: the second tier of the hierarchy. Country-level regulatory and ethics content hangs here.
study_site__v - Study Site: the lowest tier of the hierarchy.
ctn__v - Clinical Trial Notification: the regulatory notification record and its associated data, used where a country requires notification before a site may start.
cycle_time__v - Cycle Time: Vault's own measure of elapsed time between milestone points, used for standard start-up metrics.
direct_data_extract - The Direct Data API file feed: full, incremental and log extracts of the whole Vault as CSV inside gzip-compressed tar archives, with paired _deletes files. The practical way to keep an event log in step with Vault rather than re-pulling it.
milestone_dependency__v - Milestone Dependency: which milestone must complete before another can. The planned precedence a discovered process map can be compared against.
study_organization__v - Study Organization: an organization's role at study, country or site level, such as a CRO or central laboratory. The basis for comparing vendor performance.
study_person__clin - Study Person: personnel associated with a study or site, including the principal investigator. Drives person-specific expected documents such as CVs and training records.
edl_item_template__v - Template Expected Document. Generates EDL Items in bulk against open milestones; can be nested under a parent template.
edl_template__v - Template EDL. Drives bulk creation of EDLs so every study, country and site starts from the same expectation set.
milestone_template__v - Template Milestone. Lets a study plan be applied consistently across trials and countries.
study_product__v - Study Product: products associated with a study and the role each plays, for example Placebo or Lead Agent. Defaults the product field on documents.

Trial Master File (TMF)

The lifecycle of a trial master file document, from the moment the trial expects it through capture, classification against the TMF Reference Model, quality review and query remediation, to filing in a steady state and the completion of its milestone. The regulator-mandated evidence file for a clinical trial, and what an inspection actually examines.

Activities

Create Expected Document (EDL Item) - EDL automation creates edl_item__v records against open milestones from EDL Item Templates. The record creation in object_audit_trail is the moment the document becomes expected.
Upload Document to Inbox - Document create event in document_audit_trail. Documents arrive in the Document Inbox before they are classified.
Classify Document - TMF Bot or a user sets type__v, subtype__v and classification__v, binding the document to a TMF Reference Model artifact in hierarchy_item__v. Each field change is a document_audit_trail entry.
Match Document to Expected Document - The EDL matching job binds a steady-state document to its edl_item__v using edl_matching_field__v and recalculates completeness as steady-state document count divided by number expected.
Perform Quality Control Review - A QC workflow task on the document lifecycle. Task assignment and completion appear in document_audit_trail; TaskAssignment is a filterable audit event.
Raise Quality Issue - A quality_issue__v record is created against the study, country or site. Requires the Quality Issues feature to be in use.
Resolve Quality Issue - quality_issue__v lifecycle state change into a resolved state, visible in object_audit_trail.
Return Document for Rework - Document lifecycle state change back to the starting state, typically Draft or In Process. Recorded in document_audit_trail as a state change.
Approve Document - Lifecycle state change into the approval state, carrying an electronic signature where the state requires one.
Reach Steady State - The document enters its lifecycle steady state, typically Approved or Effective. Vault blocks deletion from this state, and only steady-state documents count toward EDL completeness.
Supersede Previous Version - The set-previous-steady-state-to-superseded entry action moves the prior version to superseded as the new version reaches steady state.
Complete Milestone - milestone__v state change with actual_date set. This is the deadline TMF timeliness is measured against.
Archive Study TMF - Study archival moves the trial master file into its archived state at close-out.

Case attributes

Blinded Content (boolean) - Whether the document holds blinded content, which restricts who may see it.
Document Type (string) - Document type, subtype and classification triple from type__v / subtype__v / classification__v.
TMF Artifact (string) - The zone, section and artifact the document is classified to, from hierarchy_item__v.
TMF Model Version (string) - Which published TMF Reference Model version the classification belongs to, from model__v.
Document ID (string) - The Vault document id. The case id when the case is a single TMF document.
Document Number (string) - Human-readable document number from document_number__v.
Completeness (decimal) - Steady-state document count divided by number expected on the EDL Item.
Study (string) - Study the document is filed under, from study__v.
Study Country (string) - Study country, where the document is filed at country level.
Study Site (string) - Study site, where the document is filed at site level, from study_site__v.
Document Owner (string) - Owner of the document from owner__v.
EDL Requiredness (string) - Whether the expected document is Required, Not Required, Optional or Pending Decision.
Owning Milestone (string) - Milestone the document belongs to, which sets its due point.
Lifecycle State (string) - Current state from status__v, for example Draft, In Review, Approved.
Document Version (string) - Major and minor version numbers.

Process-mining benefits (historical)

How long a TMF document really takes to become filed [Compliance]: Measure the elapsed time from the moment a document is uploaded to the moment it reaches steady state, and see the true distribution rather than the average. The long tail is where inspection risk lives, and it is usually concentrated in a handful of artifact types rather than spread evenly.
Rework loops that never show up in a status report [Efficiency]: Find documents that went round the review loop more than once. A status report shows the document as In Review either way; the event log shows whether that is the first pass or the fourth, and which reviewers and artifact types generate the repeats.
Documents that sit in the inbox unclassified [Compliance]: Uploads that were never followed by a classification are invisible to completeness reporting, because an unclassified document matches no expected document. Mining the gap between upload and classification surfaces content that is in Vault but not yet in the TMF.
Expected documents that were never fulfilled [Compliance]: Every EDL Item that never reached a match is a hole in the trial master file. Ranking those holes by artifact, country and site turns a completeness percentage into a specific worklist, and shows whether gaps cluster with particular sites or particular vendors.
Which artifacts are chronically late against their milestone [Compliance]: Compare when a document reached steady state against the actual date of its owning milestone. Documents that consistently land after the milestone they belong to are the ones an inspector will find, and they are usually the same few artifact types on every trial.
Where quality issues cluster, and what they cost [Cost]: Quality issues raised against a study, country or site are a direct signal of where the process is failing. Mapping them onto the document path shows whether they come from a step, an artifact type, a site or a particular CRO, which is a different conversation from a raw issue count.

Process-mining benefits (action)

A daily worklist of documents breaching TMF timeliness [Service]: Rank documents that are past their expected filing point against their owning milestone, newest breach first, so the TMF team works the queue that actually threatens inspection readiness rather than the whole backlog.
Warn before a milestone completes with gaps [Compliance]: Alert when a milestone is approaching completion while its expected documents are still unmatched. Closing a milestone with holes is far more expensive to fix afterwards than chasing the documents beforehand.
Send rework straight back to the person who uploaded it [Efficiency]: When a document is returned for rework, route it to the uploader rather than to a shared queue. The audit trail already records who uploaded the version, so the hand-off can be automatic instead of manual triage.
Flag documents stuck in quality control [Service]: Trigger when a QC task has been assigned but not completed beyond your own threshold. Reviewer load is uneven and the queue is invisible in the document list; the task assignment events make it visible.
Catch quality issues that reopen [Compliance]: A quality issue that is resolved and then raised again on the same study, country or site is a sign the root cause was never addressed. Trigger on the second occurrence rather than waiting for a trend report.
Keep an inspection-readiness view by zone, country and site [Compliance]: Maintain a live completeness view broken down the way an inspector asks for it - by TMF zone, by country, by site - so readiness is a standing fact rather than a scramble when an inspection is announced.

Data tables

document_audit_trail - The document audit trail: every create, edit, state change, workflow task and view against a document, with who and when. This is the primary event source for mining a TMF document lifecycle.
documents - Vault document metadata: one row per document, with its classification against the TMF Reference Model and its links to study, country, site and milestone. Reached at /api/{version}/objects/documents and queryable with VQL.
edl__v - Expected Document List: the checklist of trial records expected, and explicitly not expected, at a given level of the study hierarchy.
edl_item__v - EDL Item, labelled Expected Document in most Vaults: one expected record, its requiredness, how many are expected, and how complete it is. The gap between an EDL Item and a matched document is what TMF completeness measures.
hierarchy_item__v - Artifact: one record per zone, section and artifact in each version of the TMF Reference Model. Maintained by Veeva and not editable.
milestone__v - Milestone: a planned point in the trial that a set of expected documents belongs to. Milestone completion is the deadline TMF timeliness is measured against.
object_audit_trail - The object audit trail: the same history for object records rather than documents. Carries milestone, EDL item, site and quality issue state changes.
study__v - Study: the top of the clinical hierarchy. Groups all study-related data in the Vault.
study_country__v - Study Country: the second tier of the hierarchy. Country-level regulatory and ethics content hangs here.
study_site__v - Study Site: the lowest tier of the hierarchy.
cycle_time__v - Cycle Time: Vault's own measure of elapsed time between milestone points, used for standard start-up metrics.
direct_data_extract - The Direct Data API file feed: full, incremental and log extracts of the whole Vault as CSV inside gzip-compressed tar archives, with paired _deletes files. The practical way to keep an event log in step with Vault rather than re-pulling it.
milestone_dependency__v - Milestone Dependency: which milestone must complete before another can. The planned precedence a discovered process map can be compared against.
quality_issue__v - Quality Issue: a TMF quality matter raised against a study, country or site, tracked to resolution.
study_organization__v - Study Organization: an organization's role at study, country or site level, such as a CRO or central laboratory. The basis for comparing vendor performance.
study_person__clin - Study Person: personnel associated with a study or site, including the principal investigator. Drives person-specific expected documents such as CVs and training records.
edl_item_template__v - Template Expected Document. Generates EDL Items in bulk against open milestones; can be nested under a parent template.
edl_template__v - Template EDL. Drives bulk creation of EDLs so every study, country and site starts from the same expectation set.
milestone_template__v - Template Milestone. Lets a study plan be applied consistently across trials and countries.
model__v - Model: one record per published version of the TMF Reference Model since 2012. Maintained by Veeva and not editable.
study_product__v - Study Product: products associated with a study and the role each plays, for example Placebo or Lead Agent. Defaults the product field on documents.

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