ALCOA++ in Practice - A New Dimension of Data Quality
- Edyta Jach
- November 7, 2025
In clinical trials, one fundamental question arises: can we trust the data?
Critical decisions affecting human health and safety are based on it. This immediately leads to further questions we should always consider:
- Is the data complete and intact – has anyone deleted or changed it?
- Do we know who entered the data and when, and are all actions appropriately recorded?
- Does the system ensure the confidentiality and security of patient data?
- Is the information retrievable and reproducible at any time, even years later?
- Is the data collection process consistent and reproducible, regardless of who performs it?
Sound familiar? Of course - these are the questions defined by ALCOA, the long-standing framework describing the essential attributes of trustworthy clinical data.
The ALCOA principles establish the foundation of data integrity in clinical research, specifying that data must be Attributable, Legible, Contemporaneous, Original, and Accurate. With the growing use of computerized systems, these principles evolved into ALCOA+, adding that data must also be Complete, Consistent, Enduring, and Available. In the digital era - characterized by increasingly complex data flows and heightened regulatory scrutiny - ALCOA++ further extends these requirements to include full traceability of all data and metadata throughout their lifecycle.
Together, these principles define the global standard for ensuring data integrity and credibility in clinical trials.
The ALCOA principles apply to all data used to demonstrate compliance, product quality, or patient safety - regardless of its source and format, from raw source data, through all types of data collection tools, to analytical datasets and regulatory submissions.
From Best Practice to Regulatory Requirement
ALCOA++ is not just the “gold standard” for data quality; as shown below, it represents a set of enforceable regulatory requirements that must be met in every clinical trial. From data attribution and legibility, through consistency and durability, to newer elements such as transparency, audit trail, system security and validation – these principles are explicitly embedded in current international guidelines: ICH E6 (R3) GCP , Aneks 11 , 21 CFR Part 11 , and the Guideline on Computerised Systems and Electronic Data in Clinical Trials ; (see also the previous article Trustworthy technologies - how to ensure the credibility of clinical trials in the digital era? ).
In practice, this means that sponsors and investigators can no longer treat data integrity requirements as “good practice,” but rather as a legal and ethical obligation. Every IT system - whether an electronic Case Report Form (eCRF), an electronic Clinical Outcome Assessment (eCOA), an electronic Patient-Reported Outcome (ePRO), or any other digital data capture system - must be validated, secure, and fully auditable. Only then can we be confident that decisions regarding investigational products and patient safety are based on reliable, complete, and regulatory-compliant data.
ALCOA++ and Electronic Data Capture (EDC): Translating Principles into Practice
The table below presents how the ALCOA++ principles translate into specific requirements for Electronic Data Capture (EDC) systems and related operational processes.
| ALCOA++ principle | Description | Regulatory reference | System requirements | Process requirements |
|---|---|---|---|---|
| Attributable | Data must be linked to the individual or system/device that generated it, as well as the operation performed and its timestamp (who, what, and when)) | (1; 2; 3; 4; 6) | ||
| Legible | Data must remain readable and understandable throughout the retention period | (1; 2; 4; 6) | ||
| Contemporaneous | Data must be recorded at the time of observation (e.g. ePRO/eCOA) or as soon as possible (eCRF) | (1; 2; 4; 6; 7) | ||
| Original | Data must be a true copy of the source documentation or an original record in eCRF/ePRO/eCOA | (1; 2; 3; 4; 6) | ||
| Accurate | Data must faithfully and accurately reflect observations and actual values | (1; 2; 4; 6) | ||
| Complete | All logged and deleted data, along with metadata and full change history, must be retained | (1; 2; 4; 6) | ||
| Consistent | Data must be consistent, logically and chronologically organized, and recorded according to applicable standards | (2; 4) | ||
| Enduring | Data must be stored in a way that ensures its integrity and immutability throughout the required retention period | (2; 4) | ||
| Available | Data must be readily available for review, audit, or inspection throughout the retention period | (2; 4) | ||
| Traceable | Data and metadata must be fully traceable throughout their lifecycle, clearly linking each record to its origin and subsequent changes | (2; 4; 5) |
(1) ICH E6 (R3) GCP §2.12.2; (2) Guideline on Computerized Systems and Electronic Data in Clinical Trials §4.1; (3) Guideline on Computerized Systems and Electronic Data in Clinical Trials §4.3; (4) Guideline on Computerized Systems and Electronic Data in Clinical Trials §4.5; (5) Guideline on Computerized Systems and Electronic Data in Clinical Trials §6.2; (6) Guideline on Computerized Systems and Electronic Data in Clinical Trials §6.3; (7) Guideline on Computerized Systems and Electronic Data in Clinical Trials §6.6
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