Source data is the information collected from study participants contained in original records and documents. This data can originate from various types of records, including previous medical histories, test results, and reports filled out during the study.
Definitions
ICH E6(R2)
- 1.51 Source Data:
- All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies) [1].
Examples of source data
Raw data obtained from patients is defined by the study objectives and design. Common types of information collected during a study include:
- demographics (date of birth, ethnicity, sex)
- informed consent-related information
- medical history and previous medications
- current medications
- clinical findings and observations:
- height, body weight, BMI
- vital signs
- laboratory test results, biomarker and genomic data
- adverse events
- post-treatment follow-up
Types of source data media
Clinical source data could be recorder in various documents, e.g:
- medical notes and treatment charts
- electronic health records (EHRs)
- laboratory results printouts
- patient-reported outcomes (PROs)
“Source data” vs “source documents”
Both terms are related but distinct.
| Nature | Function | |
|---|---|---|
| Source data | Source data is the actual information or data points collected | Source data provides the content needed for statistical analysis and decision-making in the trial |
| Source documents | Source documents are the physical or digital records where this data is initially recorded | Source documents provide the evidence and audit trail verifying that the source data is accurate and complete |
Source data verification
Source data verification (SDV) is a quality control procedure performed by clinical monitors. It involves reviewing and confirming the accuracy and completeness of original records and documents that contain information about study participants. This verification ensures that the clinical data reported to a sponsor accurately reflects what was recorded at the medical source.
See also
Another relevant pages
Links to this page
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