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ROLE OF NURSES IN CLINICAL RESEARCH IN MALAWI OWEN DAIRE BSCN MPH RNM

ROLE OF NURSES IN CLINICAL RESEARCH IN MALAWI OWEN DAIRE BSCN MPH RNM. INTRODUCTION. Nurse play pivotal role in clinical research Will discuss role of nurse in clinical trial in Malawi. RECRUITMENT AND RETENTION. Protocol for clinical trial defines: Population to be included

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ROLE OF NURSES IN CLINICAL RESEARCH IN MALAWI OWEN DAIRE BSCN MPH RNM

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  1. ROLE OF NURSES IN CLINICAL RESEARCH IN MALAWIOWEN DAIRE BSCN MPH RNM

  2. INTRODUCTION • Nurse play pivotal role in clinical research • Will discuss role of nurse in clinical trial in Malawi

  3. RECRUITMENT AND RETENTION • Protocol for clinical trial defines: Population to be included inclusion criteria exclusion criteria Role of nurse • raise awareness when study activated to recruit • Introduce study to participant • Discuss eligibility • Answer participant questions

  4. ENSURE PARTICIPANT UNDERSTAND TRIAL • the potential benefit of trial • alternative treatments • concepts - randomisation, single- or double- blinding, • placebos, if applicable what is expected of PPT • hospital visits, investigations • taking study medication

  5. Cont. • can be withdrawn from study at any time if in best interest • Decline participation without affecting his/her treatment

  6. VISIT PROCEDURES AND FOLLOW UP • Data collection based on SOE Provides data to answer research questions • Referral of participant to other care providers • Administration of trial agents • Ensure study staff document all trial procedures

  7. SAFETY OF TRIAL PARTICIPANTS • Reporting untoward occurrences timely • Safety of clinical environment • Following IP guidelines • Accurate record keeping • Confidentiality-protects from social harms

  8. PARTICIPANT ADVOCACY • In accordance with GCP ensure voluntary consent • Ensure participant interest is of prime importance

  9. COMMUNICATION • Multidisciplinary team: nursing, medical allied professions • Monitors

  10. Study management Ensure compliance • protocol, • SOPs • procedure manuals • regulations Resource management human material

  11. Data integrity • Training of staff • standardisation of data collection tools • Quality assurance and control

  12. STUDY COORDINATORS • works with the PI, department, sponsor Provide guidance on: • compliance • financial • personnel • other related aspects of the clinical study.

  13. GENERAL ADMINISTRATION • Ensure compliance with regulation • Develop training materials • Ensure staff meet minimum training requirements • Comply with monitoring efforts • Address audit findings

  14. cont • Budget and justification • Attend investigator meetings • Prepare regulatory submission • Maintenance of reg requirements

  15. Conduct of research • Train staff/keep record of training • Collect submit docs to sponsor e.gFDA 1572,CVs • Develop recruitment strategy • Maintain study timelines

  16. Complete study docs/ maintain docs according to sponsor requirements Communication-PI,sponsor,participants • Progress reports • Compliance reporting

  17. Project close out • Submit project close out docs • Arrange storage of study docs

  18. WHY WORK IN CLINICAL RESEARCH • Vital in future of medicine and wellbeing of future societies • Patient centred • Autonomous • Opportunity to learn new things • Rewarding

  19. Thank you

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