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 inclusion criteria exclusion criteria Role of nurse raise awareness when study activated to recruit Introduce study to participant Discuss eligibility Answer participant questions

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

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 can be withdrawn from study at any time if in best interest Decline participation without affecting his/her treatment

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

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

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

COMMUNICATION Multidisciplinary team: nursing, medical allied professions Monitors

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

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

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

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

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

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

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

Project close out Submit project close out docs Arrange storage of study docs

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

Thank you