Source documents are original records (or certified copies) where the source data is first recorded. These documents serve as the primary record of information that is then transcribed into the case report forms (CRFs) or electronic data capture (EDC) systems used for analysis.
Definitions
ICH E6(R2)
- 1.52 Source Documents:
- Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). [1].
Examples of source documents
Depending on study requirements, source documents can vary widely. Typically, source documents include:
- medical records [2]
- hospital or clinic charts [3]
- lab results
- informed consent forms
- x-rays
- ECG printouts
- drug accountability records
It is important that source documents closely resemble normal practice records. In other words, a trial site should use the same medical charts for study participants as the institution (i.e. the hospital where the site is located) uses for regular patients. In some cases, where additional information is collected by a sponsor, investigator site may use relevant forms or worksheets approved by both the study team and the site.
See also
Another relevant pages
Links to this page
- Original medical record (← links)
- Quality assurance (← links)
- Source data (← links)
- Sub-investigator (← links)
- Subject identification code (← links)
References and notes
- ↑ 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
- ↑ Holistic patient's medical history and care, encompassing documents from multiple healthcare settings
- ↑ Specific records maintained within a hospital or clinic setting during a patient's stay or visit
External links