Original medical record

Original medical record – is primary documentation of a patient’s medical information, including their medical history, diagnoses, treatments, current and previous medications, and any other relevant data.

Definitions

ICH E6(R2)

1.43 Original Medical Record:

See Source Documents .

Requirements for original records

Original medical record serves as a source of information for assessing patient eligibility, observing their health status throughout the study, and documenting any relevant medical events or outcomes. It is important to ensure the accuracy, completeness, and confidentiality of medical records to maintain data integrity and uphold patient privacy.

See also

Another relevant pages

• ALCOA
• Source documents

Links to this page

• Source data (← links)
• Certified copy (← links)