Protocol Analysis Complete
Protocol uploaded and analyzed — fact base ready for downstream generation.
Protocol → Deliverables · Single Source of Truth
From protocol to study‑ready deliverables in days, not months.
DocumentSpark extracts the structured facts inside your protocol once, then generates every downstream data management, regulatory, and SDLC validation artifact your trial needs — traceable to the clause it derives from, and re-reconciled when the protocol changes.
Aligned with
CDISC CDASH v2.2
CDISC SDTMIG v3.3
ICH E6 GCP
SCDM GCDMP
GAMP 5
FDA SDTCG
DIA TMF RM
01 / Problem
Why study setup takes months
What happens today
A team of people, retyping the same protocol by hand.
When a protocol is approved, a dozen specialists — across the sponsor, the CRO, data management, and regulatory affairs — each open the same document and start writing their own set of deliverables from scratch. They are all drawing from the same source, but they work independently and in their own formats. The documents disagree with each other before the trial even begins, and every protocol amendment forces the whole team to start reconciling all over again.
A. Manual labor
The same document, authored a dozen times over.
Every team that touches the trial reads the protocol and writes their own set of documents from scratch. The same fact ends up retyped a dozen ways, in a dozen different formats — without any of the authors reading each other's work.
B. Inconsistency
The documents disagree from day one.
Because every author works independently, almost no two documents match. Catching the mismatches is a manual job — someone has to compare the documents line by line. The errors that slip through are discovered weeks or months later, often by an auditor.
C. Human error
One missed change cascades for the life of the trial.
When the protocol is amended, someone has to find every document the change touches, open it, edit it by hand, and re-route it for review. Miss a document and the inconsistency follows the trial into data collection — where it becomes expensive to unwind.
D. Time
Four to nine months before the first patient.
Writing, reviewing, and reconciling the document set sits squarely on the critical path between an approved protocol and enrolling the first patient. Every week added there is a week the trial isn't running.
4–9mo
Study setup time
Between an approved protocol and the first patient enrolled in a mid-sized trial.
28+
Documents per study
Stand-alone documents a study team has to write and keep in sync — entirely by hand.
37%
Cost of rework
Industry estimates of trial cost driven by mid-study changes and the manual reconciliation they trigger.
02 / Process
A linear, traceable build
How it works
One protocol in. A complete study package out.
Five stages move a protocol from PDF to a deployment-ready package of CRFs, plans, specifications, and regulatory documentation — with every artifact linked to the protocol clause it derives from and re-checked whenever the protocol changes.
Stage 01
01
Ingest
Upload the protocol PDF. Manual CRF packets (DOCX) and REDCap data dictionaries (CSV) can be imported alongside.
Inputs · PDF · DOCX · CSV
Stage 02
02
Extract
A two-pass structured read turns the protocol into a typed fact base — the study arms, visit schedule, eligible population, treatments, and assessments. Every fact is reviewable against the clause it came from.
Verified · 2-pass extraction
Stage 03
03
Generate
Every downstream artifact is generated from the same fact base — CRFs, DMP, edit checks, SDTM mapping, consent forms, SDLC validation suite, TMF skeleton.
28+ artifacts · One source
Stage 04
04
Validate
Bidirectional traceability between protocol and artifacts. Quality audit runs deterministic plus structural checks; auto-repair resolves the issues that don't require human judgment.
Bidirectional · Auto-repair
Stage 05
05
Export
Deliver each artifact in the format its consumer expects — DOCX for sponsors, CDISC ODM XML for EDCs, Define-XML and a full ZIP for submission, CSV/XLSX for downstream tooling.
DOCX · ODM · Define · ZIP
03 / Preview
Inside the platform
Single source of truth
Every artifact is bound to the protocol clause that produced it.
The Protocol Intelligence workspace shows the structured model extracted from your protocol — arms, population, schedule, interventions — reviewable side-by-side with the source clause. Downstream generators consume the same fact base, so every deliverable inherits the same canonical numbers.
04 / Deliverables
A complete document set, from one protocol
Full coverage
Twenty-eight artifacts. One fact base.
DocumentSpark generates the full set of artifacts required to operationalize a trial — from case report forms to the SDLC validation package to the submission-ready CDISC bundle. Each artifact is version-controlled, reviewable, and bound to the protocol clause it derives from.
Tier I
Study setup
D-01
Study Design Configuration
SDC · arms · visits · randomization
D-02
Informed Consent Form
ICF · 6 sections, per-section regen
Tier II
Case Report Forms
D-03
Case Report Forms
CRF · canonical form codes
D-04
Annotated CRF
aCRF · SDTM annotations
D-05
CRF Instruction Guide
per-form narrative guidance
D-06
Visit–Form Matrix
visit × form assignments
Tier III
Data Management SCDM GCDMP
D-07
Data Management Plan
DMP · 18 GCDMP sections
D-08
Data Dictionary
DD · variable catalog, CT
D-09
Edit Check Specification
ECS · range · logical · derived
D-10
Data Review & Cleaning Plan
DRCP
D-11
SAE Reconciliation Procedure
SAERP
D-12
Database Lock Checklist
DBLC
D-13
External Data Transfer Spec
EDTS · per-vendor profiles
D-14
Medical Coding Specification
MCS · MedDRA · WHODrug · LOINC
Tier IV
SDTM Submission CDISC · FDA SDTCG
D-15
SDTM Mapping Package
CDASH → SDTM · lookup-first
D-16
Define.xml
v2.1 (or v2.0 pre-2023)
D-17
SDTM Reviewer's Guide
SDRG
D-18
SUPPQUAL Templates
SUPP-- supplemental qualifiers
D-19
Submission ZIP Package
full bundle · validator-ready
Tier V
SDLC Validation GAMP 5
D-20
User Requirements Spec
URS
D-21
Functional Requirements Spec
FRS
D-22
System Design Spec
SDS
D-23
Application Design Spec
ADS · target EDC
D-24
Audit Trail Design Spec
ATDS
D-25
Security & Access Controls
SACS
D-26
Internal Interface Spec
IIS
D-27
DB Physical Model
tables + attributes
D-28
Test Plan / List / Procedure
SDLC test suite
D-29
UAT Protocol
UAT · test cases + criteria
D-30
UAT Report
aggregated outcomes
Tier VI
Trial Master File DIA RM · ICH E6
D-31
TMF Zone Structure
DIA RM · 10 zones
D-32
Essential Documents Checklist
ICH E6 · before · during · after
Interoperable, EDC-agnostic
Deliver to any EDC, CDMS, or eTMF.
DocumentSpark sits upstream of your data-capture stack and exports each artifact in the format its consumer expects. Nothing locks you to a specific EDC vendor — the platform produces standards-bound, validator-ready files.
.xml
CDISC ODM 1.3
CRFs · Medidata
mdsol extensions
.xml
Define-XML 2.1
v2.0 fallback pre-2023
.docx
Microsoft Word
DMP · URS · FRS · SDS · MCS · UAT · 14 more
.csv · .xlsx
Tabular
Data dictionary · edit checks
.pdf
Annotated CRF
aCRF · regulator-ready
.zip
Submission Bundle
SDTM · Define · SDRG · SUPPQUAL
05 / Standards
Built to the frameworks you're audited against
Standards & compliance
Pinned versions. Date-resolved against the FDA catalog.
Each artifact conforms to the structural, terminological, and process standards that govern modern clinical trials. Submission targets (SDTM, Define-XML, controlled terminology) are date-resolved against the FDA Data Standards Catalog based on your study start date.
CDISC · CDASH
Clinical Data Acquisition Standards Harmonization
Pinned · IG v2.2 · 7-domain baseline
CRF fields and data collection structures conform to the CDASH model out of the box, grounded against the CDASH IG v2.2 baseline.
CDISC · SDTM
Study Data Tabulation Model
SDTM 1.7 · SDTMIG 3.3 · CT 2025-09
SDTM mapping is lookup-first against a 315-entry curated catalog; variables without a lookup entry are explicitly annotated NOT SUBMITTED rather than guessed.
CDISC · Define / ODM
Define-XML 2.1 · ODM 1.3
v2.0 / pre-2023 fallback via FDA catalog
Define.xml and ODM exports follow CDISC structure; ODM uses the Medidata
mdsol vendor extensions where applicable.ICH · E6 GCP
Good Clinical Practice
R2 / R3 (2025)
Generated artifacts preserve the traceability, version control, and audit posture required by ICH E6.
SCDM · GCDMP
Good Clinical Data Management Practices
Per-chapter (2023 / 2025)
DMP, edit checks, DRCP, and SAE reconciliation follow GCDMP guidance — the 18-section DMP carries per-section excerpts as the generation contract.
ISPE · GAMP 5
Good Automated Manufacturing Practice
Framework for SDLC suite
URS, FRS, SDS, ADS, ATDS, SACS, IIS and the full test suite are produced under a GAMP 5 framework with bidirectional traceability.
FDA · SDTCG
Study Data Technical Conformance Guide
May 2023
Submission-bound artifacts align with FDA's technical conformance requirements for study data. Versions are resolved from the FDA Data Standards Catalog by study start date.
FDA · CSA & CSV
Computer Software Assurance
Cited in ADS · ATDS · SDTM
Validation deliverables incorporate FDA computer-systems guidance (2007 + Oct 2024 Q&A) and CSA-aligned risk-based test rationale.
DIA · TMF RM
DIA Reference Model
10-zone structure
The TMF scaffold is seeded against the DIA Reference Model, with the ICH E6 essential-document checklist organized into before / during / after trial categories.
Governance · 01
Bidirectional traceability
Every artifact carries a back-reference to the protocol clauses it depends on; validation runs both ways — protocol → artifact and artifact → protocol.
Governance · 02
Version-controlled artifacts
Integer-versioned artifacts with immutable per-version history. Lifecycle moves draft → in review → pending approval → approved, with superseded on amendment.
Governance · 03
Recorded approval
Approval requires password re-confirmation; each approval persists a signature timestamp and signature meaning against the artifact version being signed.
Governance · 04
Immutable change history
Every state change writes to an immutable change log — user, action, resource, before/after — exportable for sponsor governance and oversight.
06 / Audience
Who DocumentSpark is for
Built for the full trial team
One platform, every role in the study build.
From sponsor to CRO to regulatory affairs, DocumentSpark replaces fragmented authoring tools with a single environment that produces every deliverable each function depends on — without locking the trial to a single EDC or vendor.
01
Sponsors
Compress study start-up timelines, reduce vendor dependencies, and maintain a single source of truth across portfolios. Hand a complete, validated package to any CRO or EDC.
Sponsor leadership · Program management
02
CROs
Standardize study build across clients and EDCs. Move faster on competitive bids by reducing the cost of upfront authoring work; compress UAT by validating against the source protocol.
Operations · Study delivery
03
Clinical Data Managers
Author CRFs, edit checks, and the DMP from a structured protocol model instead of free text. Catch amendment impact before it reaches UAT through traceability and the staleness flag.
Data management · Biostatistics
04
Regulatory, QA & PIs
Inherit traceability and version control by default. Submit study data aligned to the FDA conformance guide without rework; investigators see consent and assessments derived from the protocol they approved.
Regulatory · Quality assurance · PIs
07 / Engage
Request a demonstration
Request a demo
See your protocol generate a study package.
Bring a redacted protocol or a representative document from a recent trial. We will walk you through the structured extraction, the generated deliverables, and the traceability model — live, against your own content.