Page 5 - Research Compliance Welcome Package (1.4.19)

ALCOA: Solving the Puzzle of Quality Documentation
A study is only as strong as the data it collects, so how do you know that you’re getting the quality you need? Whether you’re recording initial data, making corrections, or submitting info to a study sponsor, ALCOA can be just the solution you’re looking for.
ALCOA is an acronym that stands for attributable, legible, contemporaneous, original, and accurate. It’s used throughout the research industry to refer to the essential elements of data quality.
Across
1. Attributable data can be traced to the individual who observed and recorded it. Data should be signed or initialed by the person entering it and dated on the date of entry.
3. Contemporaneous data is recorded promptly, preferably at the time observations are made and procedures conducted.
5. Accurate data is authentic, correct, and should be collected according to the approved protocol.
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2. Legible data is readable and recorded permanently in a durable medium that allows future access of the
information.
4. Original data is the initial record of activities and observations. This includes hospital records, clinic charts, subject diaries, or handwritten notes.
BSWH Research Compliance | 2401 S. 31st St. | MS-AR-M300 | Temple, TX 76508
254-215-9025 (x21-9025) Office | 254-215-9061 Fax | Research Compliance Office | ResearchCompliance@BSWHealth.org
10/16/18