Table 2.

Data source

Data	Source
Participant- reported outcomes	The original participant-completed CRF is the source and will be kept with the participant’s trial record at site, while copies will be provided to the Trials Office
Lab results	The original lab report (which may be electronic) is the source data and will be kept and maintained in line with normal local practice. Information will be transcribed onto CRFs
Imaging	The source is the original imaging usually as an electronic file. Data may be supplied to the Trials Office as a password-protected, anonymised, copy of the electronic file or as an interpretation of the imaging provided on a CRF. This will be transferred via fax or secure email, and stored on a secure computer server at the University of Birmingham. Where data are interpreted, the CRF onto which it is transcribed becomes the source. A copy of the CRF should be provided to the Trials Office.
Clinical event data	The original clinical annotation is the source data. This may be found on clinical correspondence, or electronic or paper participant records. Clinical events reported by the participant, either in or out of clinic (eg, phone calls), must be documented in the source data.
Health economics data	Often obtained by interview directly with the participant for transcription onto the CRF.
Recruitment	The original record of the randomisation is the source. It is held on University of Birmingham servers as part of the randomisation and data entry system.

CRF, case report form.