FDA Guidance for Industry: Electronic Source Data in Clinical Investigations states that data should meet certain fundamental elements of quality. Whether they're recorded on paper or electronically, source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA).
The acronym ALCOA has been around since the 1990’s, and is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates to data, whether paper or electronic. The "plus" refers to the acronym CCEA which extends ALCOA to also require that data is complete, consistent, enduring and available.
Compliance to these standards is, however, expected also by the NIH and EMA.
Good documentation practice in clinical research (as this paper indicates) should be part of all research. However, ALCOA is often seen only as a prerequisite standard to comply with for human trials and GLP research.
With Study, your non GLP discovery research can achieve the ALCOA+ standards without the high cost and process overheads. The ALCOA+ standards are built into the Study solution as explained below.
| Attributable | All Study records created are stamped with the authors name, plus the time and date the record was added and amended |
| Legible | Study is online and computer based, so all documentation is electronic and human readable. Study was designed to enable you to move away from using paper lab note books and keeping scanned copies of notes |
| Contemporaneous | All records created in Study, whether experiment results, health observations or simply tasks, have a time and date added to them for complete transparency of the data timeliness |
| Original |
If you use Connect to collect experimental data, the source is attributable back to the device from which the data was sourced. If you enter results manually, and you make any change, the original data record is maintained with a full audit trail of the original values and who made the changes. Study does not delete data - it archives it and keeps it as a history record. We back up your data daily and keep data for 5 years. |
| Accurate |
Data collected via the Connect system and associated with digital animals (tagged with the Somark Digitail tag) eliminates usual sources of data error. It removes animal identification errors and transcription errors. Even animals identified using the Labstamp tail tattoo system have a less than 3% rate of misidentification and data error - well within tolerances for statistical confidence. |
| Complete | Study provides a complete record of your experiments: the design, the scheduling, the results capture, who performed the work and when, plus all the necessary reference data, as recommended by the ARRIVE Guidelines |
| Consistent |
Study validates data entry, provides controlled reference data (System Administrators maintain key information about animals and methods) and ensure referential integrity between records - such as experiment results to animals - animals to locations and people to tasks and results. Unlike spreadsheets, where terms and values can be captured in different ways by end users, Study ensures consistent values, terms and data storage, for example - ensuring integers are stored as numbers. Study also ensures image records and files can be stored with the correct animal and study. |
| Enduring | Study data is backed up to a secure site every 15 minutes. Data is stored for up to 5 years - and can be stored for longer if required. |
| Available |
Study enables you to share your data online, in real time via secure user logins and passwords. You can also export your data to CSV files to share or you can point other systems to your data via our APIs and open interface options. |