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 criteriaRole of nurse raise awareness when study activated to

recruitIntroduce study to participantDiscuss eligibilityAnswer 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 PPThospital 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can be withdrawn from study at any time if in best interest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 SOEProvides data to answer research questionsReferral of participant to other care

providersAdministration of trial agentsEnsure study staff document all trial

procedures

SAFETY OF TRIAL PARTICIPANTS

Reporting untoward occurrences timely

Safety of clinical environmentFollowing IP guidelinesAccurate record keepingConfidentiality-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• regulationsResource management human material

Data integrity

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

STUDY COORDINATORS

works with the PI, department, sponsorProvide guidance on: compliance financialpersonnel 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,participantsProgress 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 centredAutonomousOpportunity to learn new thingsRewarding

Thank you