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 [1].
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
Links to this page
- Source data (← links)
- Certified copy (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
External links