The clinical database will preferably be established in a leading professional data management system, Clintrial.

CLINICAL DATA COORDINATION
On the day of receipt at Omega Mediation the patient documentation (CRFs, laboratory reports, etc.) collected by the CRA (or arrived at Omega Mediation) will be registered in the Tracking and Logging System.

SECONDARY (IN-HOUSE) REVIEW (QC) OF CRFs AND DATA QUERY PROCESS
A quality control review (secondary review) of all CRFs at Omega Mediation may take place and is performed independently from the CRAs involved in the clinical monitoring. The extent of this review step will be defined by the sponsor.

Queries will be issued according to the Data Validation Plan which is part of the DMP. They will preferably be generated in a fully automated way from the database system. They will be printed on Data Discrepancy Forms (DDFs) and may be discussed with the involved monitor prior to issue to the investigator. Outgoing and incoming queries will be tracked; resolutions will be included in the database and the data will be re-validated again.

CODING
The Clinical Data Management staff at Omega Mediation may perform the coding of adverse events, medical history, concomitant medication and diseases by using the sponsor's or standard dictionaries (e.g. MedDRA, WHO Drug Dictionary, ICD).

DATA ENTRY
Double data entry is the standard procedure with two independent and specifically trained data entry clerks and a professional person for resolving inconsistencies in a verification step. Unexpected data will be entered as flags and notes.