The data and records needed that are described refer to the entire CRC screening process, not only for testing with iFOBT.

According the European guidelines (2010) {6}, relevant data on each individual and every screening test performed must be recorded, including the test results, the decision made as a consequence, diagnostic and treatment procedures and the subsequent outcome, including cause of death, should be ensured. The data must be linked at the individual level to several external data sources including population register, cancer or pathology registries, and registries of cause of death in the target population, to be able to evaluate the effectiveness of screening.

Legal authorisation should be put in place when the screening programme is introduced in order to be able to carry out programme evaluation by linking the above-mentioned data for follow-up (VI - A).

A database consisting of individual records (one record per person for each screening episode) is essential in order to produce results on screening performance (VI - A).

Quality control procedures for the database should be available and run regularly to check the quality of the data and to correct any data entry errors. (VI - A).

A table should be made to present the test results (positive, negative, or inadequate) by gender and age.

Following Process variables in screening with the faecal occult blood test (FOBT) and other in vitro tests should be applied: Screened/tested; Inadequate test; Positive test; Referral to follow-up colonoscopy.

Following Outcomes variables should be applied to CRC screening performed with any of the currently available primary screening tests; follow-up colonoscopy; lesions; adenomas; advanced adenoma; cancers; severe complications required hospitalizations; 30-day mortality.

Following data tables should be produced: target, eligible, invited, screened/tested at 1^st screening and at subsequent screening episodes; inadequate test; positive test or screening; follow-up colonoscopy examination attended; negative follow-up colonoscopy examination; positive follow-up colonoscopy examination; lesion detected; adenoma detected; non-advanced adenoma detected; advanced/high-risk adenoma detected; cancer detected by stage.