ALCOA-CCEA

Attributable

Legible

Contemporaneous

Original

Accurate

Complete

Consistent

Enduring

Available

✅ When a clinical research coordinator records a participant’s blood pressure, they must sign or initial the entry and include the date and time. This ensures that the data can be traced back to the person who recorded it, providing accountability and traceability. ✅ If a lab technician performs a blood test, they should document their initials and the date on the test results to maintain a clear record of who conducted the test. ❌ A nurse records a participant’s temperature but does not include their initials or the date, making it unclear who took the measurement and when.

✅ All entries in a participant’s medical record must be written clearly and legibly. If handwriting is difficult to read, it can lead to errors in data interpretation. Using electronic data capture (EDC) systems can help ensure that data is recorded in a standardized, legible format. ✅ When documenting a participant’s medication dosage, the coordinator uses block letters to ensure clarity and prevent misinterpretation. ❌A doctor writes a prescription in cursive that is difficult to read, leading to potential errors in medication administration.

✅ Data should be recorded at the time of the participant’s visit, not retrospectively. For instance, if a participant reports an adverse event during a visit, the details should be documented immediately, including the date and time of the report. ✅ During a clinical trial, a nurse records the participant’s vital signs immediately after taking them, ensuring the data is accurate and timely. ❌ A researcher waits until the end of the day to document all participant interactions, risking inaccuracies and omissions.

✅ The first recording of data should be maintained as the source document. If a participant’s temperature is taken, the initial reading should be recorded directly in the source document, not on a scrap piece of paper to be transferred later.✅ When collecting a participant’s consent, the original signed consent form should be kept in the participant’s file as the primary source document. ❌ A coordinator writes down a participant’s weight on a sticky note and later transfers it to the official record, increasing the risk of transcription errors.

✅ Data entries must reflect the true observations and measurements taken during the study. If a participant’s weight is measured, it should be recorded exactly as observed, without rounding or estimating. ✅ When recording a participant’s blood pressure, the exact reading from the monitor should be documented, ensuring precision. ❌ A researcher estimates a participant’s height instead of measuring it accurately, leading to potential data inaccuracies.

✅ All required data fields should be filled out completely. If a form requires information on a participant’s medication history, every relevant detail should be included, ensuring no omissions that could affect the study’s outcomes. ✅When documenting a participant’s medical history, the coordinator ensures all sections of the form are filled out, including past illnesses and current medications. ❌ A researcher leaves several fields blank on a participant’s data collection form, resulting in incomplete data.

✅ Data should be recorded in a consistent manner throughout the study. For instance, if a participant’s blood pressure is measured using a specific device, the same device should be used for all subsequent measurements to ensure consistency in the data collected.✅During a clinical trial, all participants’ blood samples are analyzed using the same laboratory equipment to maintain consistency. ❌ Different devices are used to measure participants’ blood pressure at different visits, leading to inconsistent data.

✅ Data should be readily accessible for review and audit. For instance, if a regulatory authority requests access to a participant’s medical records, the records should be easily retrievable and provided in a timely manner to facilitate the review process. ✅ Electronic health records are organized and indexed, allowing quick access for audits and reviews. ❌ Records are stored haphazardly, making it difficult to locate specific documents when needed for an audit.

✅ Data should be preserved in a durable format. For example, electronic records should be backed up regularly and stored securely to prevent data loss. Paper records should be stored in a way that protects them from damage or deterioration over time. ✅ Clinical trial data is stored in a secure, cloud-based system with regular backups to ensure data integrity and longevity. ❌ Paper records are kept in a damp storage room, leading to potential damage and data loss over time.