SOURCE DATA VERIFICATION

	ECRON monitors keep for each patient a study-specific source data (SD) checklist, updated at each monitoring visit. The source in the local language is verified by the bilingual monitor, who documents the findings in the list in English
		SD Checklists are kept in English independent of the language of the source so that the sponsor gets a uniform documentation for all countries involved
		This checklist documents the proven availability of correlating source documents and the correctness of their transcription into CRF.

As benefit and advantage of a study-specific checklist all parties get

• documentation of findings
  availability, correctness (patient identification, date, parameters, values, methods, equipment used, etc.)
• monitoring instructions
  with specific checkpoints adapted to study design and schedule (e.g. dispensation and return of medication, patient diaries, external investigations, etc.)
• worksheet of the monitor
  for case-related notes, items to be checked again during next monitoring, missing data, open questions etc.
  Monitors may pass the list to the project manager for discussion of specific problems of a case.