In this QCast episode, co-hosts Julia and Tom unpack the ALCOA++ principles, the ten core attributes that safeguard data integrity in clinical trials from first observation to final archive. We’ll guide you through the original ALCOA pillars – Attributable, Legible, Contemporaneous, Original and Accurate – and then dive into the five additional attributes – Complete, Consistent, Enduring and Available when needed, and Traceable – showing how they underpin Good Clinical Practice, electronic audit-trail requirements and modern digital workflows.
You’ll discover why embedding ALCOA++ end-to-end helps prevent regulatory delays, slashes rework, and keeps patient safety front and centre. We also share practical steps for mapping your data flow, building validation at the source, synchronising device clocks to an external standard such as UTC, and running inspection-style drills. Whether you’re a data manager, quality-assurance specialist or trial-operations lead, this episode will give you the insights you need to implement ALCOA++ with confidence.
What are the ALCOA++ Principles?
The ALCOA++ framework defines ten key attributes that ensure every piece of clinical trial data is trustworthy from capture through submission. Its roots lie in Good Clinical Practice and electronic audit-trail regulations, making it the universal benchmark for paper and electronic records alike.
Core Components of ALCOA-Plus
Attributable: Every data point clearly shows who recorded it and when through unique logins, biometric sign-ons, and time stamps.
Legible: Records must be readable now and decades later. Avoid fading ink or proprietary formats.
Contemporaneous: Data are entered as observed, not reconstructed later. Ensure device clocks are synchronised to an external standard (e.g. UTC/NTP).
Original: Preserve the first capture (or a certified true copy) as the definitive source. All derivatives must point back.
Accurate: Entries match reality through calibrated instruments, automated range checks, and transparent amendment logs.
Complete: Nothing is ever truly deleted; corrections sit alongside originals in the audit trail.
Consistent: Entries follow a strict chronological order. Records must read like a diary, not shuffled notes.
Enduring: Data remain accessible and readable over time via validated backups, disaster-recovery tests, and format reviews.
Available when needed: Any authorised user can retrieve records promptly via indexed storage, reliable server up-time, and clear access roles.
Why ALCOA++ Beats Makeshift Methods
By replacing untracked spreadsheets, manual sign-offs and siloed systems with standardised attributes and audit-trail controls, ALCOA++:
Eliminates ambiguity over who did what and when.
Guards against data loss, format obsolescence and timeline gaps.
Speeds up inspections with instantly retrievable, organised records.
Reduces re-work, regulatory queries and submission delays.
Operational Essentials for Implementation
Map Your Data Flow from first capture to archive, tagging each step against the nine attributes.
Build Validation at Source by calibrating devices, enforcing eCRF edit checks, and locking down user roles before study start.
Foster a Culture of Integrity by training teams on why each principle matters, not just how to comply.
Run Inspection Drills by picking random data points and timing your team on retrieving originals, audit trails, and corrections. Add risk-based, trial-specific audit trail reviews, manual and/or automated, with documented scope, frequency, and responsibilities.
Common Pitfalls to Avoid
Relying on unmonitored spreadsheets or makeshift data extracts.
Shared or generic user credentials instead of unique logins.
Device clocks not synchronised to an external standard, breaking contemporaneous links.
Treating ALCOA++ as a one-off checklist rather than an ongoing practice.
Implementing ALCOA++ end-to-end ensures your trial data remain robust, inspection-ready and above all, safe for downstream decisions.
Jullia
Welcome to QCast, the show where biometric expertise meets data-driven dialogue. I’m Jullia.
Tom
I’m Tom, and in each episode, we dive into the methodologies, case studies, regulatory shifts and industry trends shaping modern drug development.
Jullia
Whether you’re in biotech, pharma, or life sciences, we’re here to bring you practical insights straight from a leading biometrics CRO. Let’s get started.
Tom
Today we’re diving into the ALCOA++ principles, the framework that underpin data integrity in every regulated trial. ALCOA stands for: Attributable, Legible, Contemporaneous, Original and Accurate. If you work with study records, you’ll likely have already heard the acronym. They might sound complex and like another hoop to jump through; however, get them wrong and your whole submission can unravel.
Jullia
Thanks, Tom. To understand their impact, the listeners should know that about 80 percent of all data integrity warning letters issued by regulators from 2014 to 2018 directly cited ALCOA principle failures. These principles sit at the heart of Good Clinical Practice and Good Manufacturing Practice, and they apply whether your records live in a leather-bound notebook or a cloud server. That’s why it’s so important to get them right from the beginning to save you headache later down the line. By the end of today’s episode, you’ll know why these principles still matter today, their core attributes, the four ‘plus’ additions, the new ‘traceable’ expectation, and how they slot into everyday workflows.
Tom
Let's start off by discussing why data integrity matters. Agencies like the FDA and EMA see poor record keeping as a threat to patient safety. Since 2008, warning letters for data integrity failures have risen steadily. In fact, as you just mentioned Jullia, more than four of every five letters from 2014 to 2018 pointed to these exact issues. Why does this remain such a hot topic?
Jullia
Put simply, if the evidence behind a new therapy can’t be trusted, everything else such as risk benefit assessment, dosing decisions, and labelling starts to wobble. Modern trials add complexity through remote visits, wearable devices, and machine-learning endpoints. Each new data source brings another point where errors, accidental deletions or even malicious tweaks can creep in. Regulators therefore treat integrity as foundational. Without a clear audit trail that shows who captured each data point, when it was captured and how it has, or hasn’t, been altered, reviewers can’t be confident that the numbers reflect real patient experience. So, integrity isn’t just paperwork for paperwork’s sake. It’s the foundation of credible science. It also safeguards privacy and controlled access to Protected Health Information by ensuring only authorised, authenticated users can view or change records.
Tom
Great, thanks Jullia. Next up, what is ALCOA and why does it matter for compliance? The term goes back to the 1990s, when the FDA introduced it to standardise good documentation. At its core, ALCOA lists five qualities every data record must meet. Can you run through them for us before we dive deeper?
Jullia
Sure. So, ALCOA stands for Attributable, Legible, Contemporaneous, Original and Accurate. “Attributable” means the record unambiguously shows who captured the information and when. “Legible” is self-explanatory. If a note can’t be read in ten years’ time, it might as well not exist. “Contemporaneous” insists the entry is made at the moment of observation, not recreated later from memory. “Original” reminds us that the first capture, or a certified true copy, is the gold standard against which all copies must be traced. Finally, “Accurate” demands records be error free, with any corrections clearly documented rather than overwritten and, where appropriate, the reason for change recorded. These five pillars are the foundation of every electronic audit trail or paper signature log you see today.
Tom
Now that we’ve covered the basics, let’s dive into each principle. First up is Attributable. That means using unique logins and secure audit trails. Why do those safeguards matter in real-world practice?
Jullia
Attribution is all about accountability. If a lab technician’s electronic signature is unique and time-stamped, investigators can trace a questionable value back to the exact instrument and operator. That traceability makes investigations efficient and discourages tampering. Next is legible. Think of ageing thermal paper ECG strips. If they fade, the data is lost. Digitally, legibility means choosing file formats you can open even decades from now. Contemporaneous ties collection time to entry time. Your entry time must match the collection time. If device clocks are out of sync that link breaks, so synchronising all devices to an external standard such as Coordinated Universal Time via a network time source is key. For Original, preserve dynamic source data like device waveforms or eCOA event logs, and manage certified copies under controlled procedures so fidelity is maintained. For Accurate, use calibrated devices, validated interfaces and transfers, and ensure amendments never obscure the original entry.
Tom
Building on those five, today’s ALCOA++ adds Complete, Consistent, Enduring, Available when needed, and Traceable. How did these additions become essential once sites moved from being exclusively in the likes of ring-binder folders to cloud servers?
Jullia
Good question, Tom. Complete means you never actually delete data. If an entry turns out to be wrong, you still keep a snapshot of the original alongside the correction. Consistent is all about order. Your records should read like a diary, not a jumble of notes. That means every update gets its own date and time stamp, in the right sequence. Enduring speaks to longevity. A PDF sitting on an old unsupported server is useless if you can’t open it five years down the line. To avoid that, keep validated backups, run regular disaster recovery tests and check your file formats often. Available when needed means that authorised users can retrieve any record promptly throughout the study life cycle. That means indexed storage, reliable server uptime and clear access roles. And finally, Traceable means every change to data or metadata is captured without obscuring the original, so the full history can be reconstructed end-to-end. These five additions round out the framework, making it future proof for electronic data capture and virtual or decentralised trials moving forward as the drug development landscape continues to shift.
Tom
For listeners managing studies right now, what should they do next to embed ALCOA++ without drowning in red tape?
Jullia
I’d recommend following four steps. First, map your data flow from the moment data is captured all the way to its final archive. Include all systems such as EDC, eCOA and wearables, and confirm roles so investigators retain independent access, ensuring no single party has exclusive control. Tag each step with the relevant ALCOA++ attribute. You’ll spot gaps right away. Second, build validation into the source. This might include calibrating devices, enabling automatic range checks and locking user roles before the first patient visits. Validate interfaces and transfers and protect PHI with access controls and authentication. Next, cultivate understanding, not just compliance. Make sure to brief staff on why each principle exists, because people safeguard what they value. Run risk-based, trial-specific, ongoing audit trail reviews focused on critical data, with documented scope, frequency, responsibilities, and outcomes. Lastly, rehearse inspections. Pick a random data point and time how long it takes the team to surface the original, the audit trail and any amendments. If it takes more than a few minutes, you’ll know to refine your storage or indexing. Common pitfalls to achieving this level of efficiency include shared passwords, device clocks not synchronised to an external standard and over-use of untracked spreadsheets. Being mindful to fix those early saves painful re-work later down the line.
Tom
Before we wrap up, let’s recap the top takeaways. One: regulators equate trustworthy data with participant safety, so integrity is non-negotiable. Two: the original ALCOA attributes, Attributable through Accurate, still anchor every good record. Three: the ALCOA++ additions, Complete, Consistent, Enduring, Available when needed and Traceable, make the framework fit for digital trials.
Jullia
Thanks, Tom. And with that, we’ve come to the end of today’s discussion on the ALCOA++ principles. If this episode inspired you or was helpful, don’t forget to subscribe to QCast, leave a review or share it with a colleague. And if you’d like to learn more about how Quanticate supports data-driven solutions in clinical trials, head to our website or get in touch.
Tom
Thanks for joining us, and we’ll see you in the next episode. Until next time.
QCast by Quanticate is the podcast for biotech, pharma, and life science leaders looking to deepen their understanding of biometrics and modern drug development. Join co-hosts Tom and Jullia as they explore methodologies, case studies, regulatory shifts, and industry trends shaping the future of clinical research. Where biometric expertise meets data-driven dialogue, QCast delivers practical insights and thought leadership to inform your next breakthrough.
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