Clinical Trials and Research

Documents

• Procedure for Managing Research Documentation
• Clinical Research Conduct Checklist
• Research Risk Management Plan
• Confidentiality Agreement for Clinical Research
• Agreement with a Research Team Member
• Informed Consent for Genetic Research
• Register of Biological Samples
• Register of Research Participants
• Subject's Statement of Voluntary Participation
• Amendment to Clinical Trial Agreement
• Adverse Event Reporting Procedure
• Clinical Study Monitoring Record
• Consent to Processing of Research Participants' Data
• Master Document Package for Clinical Research
• Informed Consent for a Minor Subject
• Subject Safety Report
• Register of Serious Adverse Reactions
• Agreement Between an Investigator and a Sponsor
• Report to the Ethics Committee
• Informed Consent for Participation in Clinical Research
• Agreement Between a Sponsor and a Healthcare Institution
• Clinical Trial Conduct Agreement