CONTINUOUS STATUS UPDATES

		Updates are an obligatory part of each monitoring
		Summarized status lists are provided monthly to the sponsor as hard copy or as file e.g. EXCEL.XLS, WORD.DOC etc., e-mailed
		Project management and sponsor are enabled to respond immediately to occurring problems such as slow recruitment, unexpectedly high discontinuation rate, occurrence of adverse events that are unexpected as regards rate, type or point in time

Patient Enrolment Status

• patient identification (centre, patient no., initials)
• status (in screening, not enrolled, in verum, completed, discontinued)
• dates of visits performed
• CRF parts already in house
• additional items to agree on, comments

Adverse Event Status

• patient identification (centre, patient/random no., initials)
• classification: serious (which are naturally separately reported), non-serious
• severity, relation etc.
• date of start and end of adverse event and correlation to visit schedule
• outcome and final assessment

Monitoring Activities

• all activities listed monthly and sent to sponsor together with corresponding reports
• monitoring intervals easy to be checked by project manager as well as by sponsor
• clearly listed relation between recruitment speed and monitoring frequency in each individual centre
• site visit- related travel expenses