Study Documentation

1. What is Source Data?

The ICH-GCP Guideline defines ‘source data’ as:

‘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)’.

This means that there are various types of data that are classed as source data. For example:
  • Information which the investigator writes down in the patient’s record.
  • Values in a lab result sheet or direct printout from a measuring device (e.g. analysis scale, spectrophotometer).
  • Answers which a patient enters into a questionnaire.