Reliable trial results depend on reliable records. These nine principles guide how every piece of clinical trial data is recorded, corrected, stored and made available at our Clinical Research Centre.
These six principles describe what every individual data entry must be — whether on paper or in an electronic system.
Data must clearly identify who recorded the data and when.
Data must be clear, readable and understandable.
Data must be recorded at the time the activity occurs.
Data must be maintained as original records or certified true copies.
Data must be truthful, consistent and error-free.
All required data must be fully documented.
The enhanced principles extend beyond the individual entry to how data is organised, preserved and accessed across the life of the study.
Data should be recorded in a logical and chronological order.
Data should be securely stored and retained for the required period.
Data should be readily accessible when required.
A single paper source record can show several ALCOA++ principles at once. When an error is found, it is corrected without hiding the original entry.
Illustrative example only — not a real participant record.
Date and time are written during the visit, not reconstructed later.
The wrong value stays readable under one line; the correction is initialled, dated and the reason given — no overwriting or correction fluid.
Anyone reviewing the record can see who made each entry and change, and when.
Download this guide, or see how data integrity fits into the ICH E6(R3) Good Clinical Practice framework.
Prepared by the Clinical Research Centre, KG Hospital. Data at our site is maintained in accordance with ALCOA++ principles, ICH-GCP E6(R3) and the NDCT Rules, 2019.