Trial managers: Sponsors Perspective Mary Perkins Deputy Director of Research.

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Presentation transcript:

Trial managers: Sponsors Perspective Mary Perkins Deputy Director of Research

We Trial managers

What does a sponsor want from you? Manage rather than coordinate Address conflict Propose solutions Communicate with us

FunderSponsorInvestigatorsCare Organisation Employing (researcher) Organisation Scientific Quality Assurance Quality Assurance and quality control Ensuring adequate resources are in place (staff, equipment, time etc) Quality of CareManaging Funds Value for money (research costs) Securing written agreements for all aspects of trial Compliance with protocolHolds a duty towards those harmed by a study Holding grant contracts Value for money (NHS costs) Data IntegrityInvestigational Medicinal Product accountability Written permission from authorised signatory for research to start on site Promoting a Quality Research Culture Adequacy of Trial DesignRandomization and UnblindingRequire evidence of ethical review Action on misconduct or fraud IndemnityInformed consent of participantsAction on fraud and misconduct Trial Management Data Handling and Record Keeping Records and reportsEnsure studies are properly designed and submitted for review Investigator SelectionProgress Reports Compensation to Participants Safety Reporting Financing/arranging finances Final Reports Submission to Regulatory Authorities Design of study Confirmation of Review by REC Conduct of Study Information on investigational products Feeding back results to participants Supply and handling of investigational products Adverse Drug Reaction reporting (regulatory) Monitoring Take action for non- compliance Notifying serious breaches