All requested information in the CRF should be completed in a neat legible manner. Use of a black ball pen is recommended to ensure clarity of reproduced copies in the CRF. All corrections in a paper CRF must be made in a way that does not obscure the original entry. The correct data must be inserted, dated and initialled by the investigator Data that are not available or not done should be made clear by adding NA or ND. A declaration ensuring accuracy of data recorded in the case report forms must be signed by the investigator.