Study Monitoring in consultation with Data Management and Medical
Department takes care of:

• CRFs
• CRF user instructions
• Investigator handling instructions
• Patient diaries
• Investigator files
• Study master files
• Plausibility checklists and SDV checklists
• Feasibility questionnaires
• Data validation plans
• Site selection
• Prestudy visits
• Organization of investigator meetings
• Management of investigator contracts
• Submission of study documents to BfArM
• Submission of study documents to ethics committees and follow-up
• Announcement of investigators to agencies

During studies Study Monitoring carries out:

• Initiation visits
• Interim monitoring visits
• Telephone monitoring
• Support of study sites
• Study close-out visits
• AE reporting to sponsor
• Drug accountability management
• Query management
• In-house plausibility checks

Project management for smaller studies is taken over by study monitoring
(see also central management of large international studies):

• Project-specific SOPs
• Project descriptions specifying deliverables and responsibilities based on a comprehensive standard template
• Training of project team
• Internal and external communication plans
• Status reports
• News letters
• Monitoring guidelines/plans
• Training of investigators
• Correspondence and meetings with sponsor
• Calculation of investigator honoraria and patient reimbursements
• Logistics of study material, support with central readers and laboratories
• Tracking of expiry dates of study medication
• Assistance in preparation of study reports and publication manuscripts
• Preparation of audits
• Data coding using MedDRA, WHO and sponsor-owned thesauri