Source Data is defined as all information in original records and certified copies of original records of clinical findings, observations, or other activities (in a clinical investigation) used for the reconstruction and evaluation of the trial. This typically comes down to the first place that a data point is recorded. The Investigator and designated research personnel are responsible for clearly identifying the data and documents that will be maintained as source data and documentation for the research at the start of and throughout the trial.
Source documentation should meet ALCOA-C standards. Source data should be attributable, legible, contemporaneous, original, accurate, and complete.
- Attributable: It should be obvious who wrote or did what.
- Legible: Can it be read? Never use pencils to record source documents, use dark colored ink. Avoid abbreviations.
- Contemporaneous: The information should be current and documented in the correct time frame.
- Original: Original or a certified copy or a printout from an electronic data source.
- Accurate: Are conflicting data recorded elsewhere? Content should precisely reflect the event being recorded.
- Complete: Source documents should be complete and not missing any information.
Source Documents may include: hospital records, subject diaries, pharmacy dispensing lists, test results, x-rays, lab records, etc.
If source documentation is incorrect, incomplete, or otherwise deficient, research personnel may correct and/or complete by making an additional entry or addendum to the source documentation. The late entry must be signed or initialed and dated in present time by the person making the entry.
Research personnel must NOT modify past-dated source documentation in research records in an attempt to resolve deficiencies. Altering past-dated records is potentially fraudulent.
If it is noted in the research record that data are missing and those data are then obtained or found at a later date, study personnel will ensure that its incorporation in the research record is noted. The notation must be signed or initialed and dated.
With Sponsor approval, study personnel may use Case Report Forms (CRFs) as source documents if they were used to initially record data and they accurately represent data collected for the study.