Study Documentation

Having good source documents in a clinical trial is vital for the quality of the study. Therefore they need to fulfil certain characteristics:

• Attributable - it must be clear to which participant they belong.
  
• Legible - they must be readable.
  
• Contemporaneous - they must be noted immediately after the data is generated.
  
• Original - they must be the original.
  
• Accurate - they must be reliably correct.
  
• Originator information – who entered the data and when.
  

If data are collected via an electronic mean, the machine (and software) must be identifiable and be calibrated and validated.

For an inspection the source data must be made available in a computerised format compliant with the EMA Q&A: Good clinical practice (GCP). For this purpose CRFs are prepared. The investigator and study staff are requested to enter the required data from a patient’s source documents into a patient-specific CRF. It is very important that no mistakes are made in this transcription process and that the information provided in the CRFs is complete.