This aims to ensure compliance to the protocol and ethics committee requirements, to ensure consecutive patient enrolment and to obtain complete, accurate and reliable data. Clear definition of the methodology, of screening and enrolment procedures are the first steps to ensure consecutive patient enrolment . These are reinforced by appropriate training of the Data Collection Officers and monitoring or auditing of the centres. Compliance to the protocol begins by checking that patients meet inclusion criteria. The questionnaire is designed to follow the protocol and limit deviation.
Any inconsistencies are subject to verification.
The data is checked on-site before transfer to the central database. The transfer process itself is then verified for its precision, the data is transferred and a check is made for discrepancies. These are reported to the Data Collection Officer for correction or confirmation, and to the Scientific Committee if needed. A final verification is made on the entire database and inconsistent data is removed before the database is locked and transferred to the statistical software.