role of nurses in clinical research in malawi owen daire bscn mph rnm
TRANSCRIPT
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ROLE OF NURSES IN CLINICAL RESEARCH IN MALAWI
OWEN DAIRE BSCN MPH RNM
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INTRODUCTION
Nurse play pivotal role in clinical research
Will discuss role of nurse in clinical trial in Malawi
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RECRUITMENT AND RETENTION Protocol for clinical trial defines:
Population to be included inclusion criteria exclusion criteriaRole of nurse raise awareness when study activated to
recruitIntroduce study to participantDiscuss eligibilityAnswer participant questions
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ENSURE PARTICIPANT UNDERSTAND TRIAL
the potential benefit of trial alternative treatments concepts - randomisation, single- or double-
blinding, placebos, if applicable what is expected of PPThospital visits, investigations taking study medication
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Cont.
can be withdrawn from study at any time if in best interest
Decline participation without affecting his/her treatment
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VISIT PROCEDURES AND FOLLOW UP
Data collection based on SOEProvides data to answer research questionsReferral of participant to other care
providersAdministration of trial agentsEnsure study staff document all trial
procedures
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SAFETY OF TRIAL PARTICIPANTS
Reporting untoward occurrences timely
Safety of clinical environmentFollowing IP guidelinesAccurate record keepingConfidentiality-protects from social harms
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PARTICIPANT ADVOCACY
In accordance with GCP ensure voluntary consent
Ensure participant interest is of prime importance
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COMMUNICATION
Multidisciplinary team: nursing, medical allied professions
Monitors
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Study management
Ensure compliance• protocol,• SOPs• procedure manuals• regulationsResource management human material
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Data integrity
Training of staff standardisation of data collection tools Quality assurance and control
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STUDY COORDINATORS
works with the PI, department, sponsorProvide guidance on: compliance financialpersonnel other related aspects of the clinical study.
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GENERAL ADMINISTRATION
• Ensure compliance with regulation
• Develop training materials
• Ensure staff meet minimum training requirements
• Comply with monitoring efforts• Address audit findings
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cont
Budget and justification
Attend investigator meetings
Prepare regulatory submission
Maintenance of reg requirements
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Conduct of research
• Train staff/keep record of training
• Collect submit docs to sponsor e.gFDA 1572,CVs
• Develop recruitment strategy
• Maintain study timelines
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Complete study docs/ maintain docs according to sponsor requirements
Communication-PI,sponsor,participantsProgress reports
Compliance reporting
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Project close out
Submit project close out docs Arrange storage of study docs
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WHY WORK IN CLINICAL RESEARCH
Vital in future of medicine and wellbeing of future societies
Patient centredAutonomousOpportunity to learn new thingsRewarding
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Thank you