Guest guest Posted January 8, 2010 Report Share Posted January 8, 2010 11. Quality Control and Quality Assurance 12. Ethics (To be covered in detail) Description of ethical considerations relating to the trial. 13. Data Handling and Record Keeping 14. Financing and Insurance Financing and insurance if not addressed in a separate agreement. 15. Publication Policy Publication policy, if not addressed in a separate agreement. Annexures: ü Investigator’s brochure ü Sample case report form (CRF) ü Informed consent form (including all applicable translations) ü Documents showing all financial aspects of the trial ü Regulatory clearance ü Insurance statement (where required) ü Signed agreement between involved parties, e.g.: § Investigator/institution and sponsor § Investigator/institution and CRO § Sponsor and CRO § Investigator/ institution and authority(ies) (where required) ü Curriculum vitae and/or other relevant documents evidencing qualifications of investigator(s) and sub-investigator(s) ü Undertaking by the investigator/s Dr. Smita The INTERNET now has a personality. YOURS! See your Homepage. Quote Link to comment Share on other sites More sharing options...
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