REDCap Validation for Regulated Contexts

Depalop provides a REDCap validation service designed to meet the typical needs of Sponsors, QA teams, and Auditors, with an approach focused on traceability and the production of complete, reusable deliverables.

Service objective

The objective is to provide the customer with a validation package that can robustly support internal and external assessments, minimizing ambiguity and non-repeatable manual activities.

The service is designed to address the increasingly frequent need to have:

consistent and reproducible evidence;
structured and coherent documentation;
end-to-end traceability between requirements, tests, and outcomes;
a clear summary suitable for non-technical stakeholders.

Structure: two-phase validation

1) Platform validation (REDCap Core)

This phase covers general capabilities that are typically considered relevant in a regulated data capture system. By way of example, the validation includes checks on:

user and role management;
access controls and permissions;
traceability of operations (audit trail), where applicable;
operational security and control aspects (e.g., sessions, management of critical functions);
exports, reports, and data extraction methods;
elements related to data integrity and process consistency.

Outcome: a “core” documentation baseline that can be maintained and updated over time and reused as a foundation for subsequent projects.

2) Project validation (Project-specific)

This phase focuses on the validation of a single REDCap project, i.e., the specific configuration used to implement the study. It is the most relevant component from a data quality perspective, as it verifies that the database design and behavior are consistent with the protocol and intended use.

It typically includes checks on:

Data Dictionary and field configuration (types, required fields, constraints, coding);
validation rules and consistency checks;
conditional logic (branching) and calculated fields, where present;
actual data entry interface behavior (messages, restrictions, save outcomes);
classic or longitudinal project configuration (events/instruments and related settings);
study-specific requirements (e.g., export methods, role-based access checks, operational procedures).

Outcome: study-oriented documentation and evidence, ready to be archived in the TMF/eTMF or within the customer’s internal systems.

Deliverables

The service produces a structured set of deliverables, typically including:

Traceability matrix: clear linkage between requirements, specifications, tests, and evidence;
Test evidence: an organized collection of proofs (e.g., screenshots and traceable outputs);
Execution report: detailed outcomes with references and timestamps;
Validation Summary Report (VSR): a synthesis document for stakeholders, QA, and audit;
Package integrity checks: mechanisms enabling verification over time of the consistency of delivered files.

Delivery is designed to be organized, easy to review, and verifiable, reducing the time required to respond to QA and auditor requests.

Customer benefits

Audit credibility: ready-to-use evidence and traceability aligned with intended use.
Risk reduction: less exposure to findings related to incomplete or misaligned documentation.
Operational sustainability: an approach that facilitates updates and maintenance over time.
Modular approach: separation between platform validation and project validation, useful for managing multiple studies.
Clarity: deliverables designed to be understandable even for non-technical stakeholders.

Target audience

The service is intended for organizations using REDCap in contexts where documented evidence is required, including:

CROs and Sponsors;
clinical sites and research institutes;
study groups requiring data integrity and traceability;
teams that need to standardize the validation process across multiple REDCap projects.

Getting started

Engagement can start with a preliminary assessment based on:

project type (classic or longitudinal);
functional scope relevant to the study;
Data Dictionary and project configuration;
QA/Sponsor requirements and audit expectations.

At the end of the preliminary assessment, it is possible to define a clear scope, a work plan, and a delivery structure consistent with the customer’s objectives.

Contact

For information about the service or to request a preliminary assessment, you can contact Depalop via the channels listed in the website’s Contact section.