The Clinical Research Support Unit (CRSU) is one of four research support units at MLW. MLW expects CRSU to provide support to investigators conducting research to the highest ethical and scientific standards. CRSU offers this support at every stage during the research project lifetime.

Vision

CRSU’s vision is to provide excellent support to the MLW researcher community to ensure rights, safety and well-being of the MLW study participants are ensured and that MLW research data is accurate and credible.

Aim

CRSU aims at supporting patient- and community-oriented research in line with the Malawian Health Research Agenda by applying best practices and therefore supporting the two major goals of the Malawi Liverpool Wellcome Trust Clinical Research Programme:

1. Preventing death from severe infection and
2. Transmission reduction in infectious diseases.

• Assisting Principal Investigators (PIs) to recruit suitably qualified clinical staff by education, training and experience for studies. Our aim is that these nurses and clinicians provide high standard of care to participants in clinical trials by utilising their skills, knowledge, experience and clinical judgment.
• Providing support to PIs with the planning, preparation and co-ordination of clinical activities when required, and ensuring that they are performed according to GCP standards.
• Developing, reviewing and updating study documents including SOPs, nursing procedures, protocols and policies as and when required.
• Promoting staff development through clinical and research training, attachment opportunities and attendance at meetings of clinical and research importance to improve patient outcomes.
• Maintaining licensure of all clinical staff through annual registration and checking staff eligibility to practice with relevant regulatory bodies, Nurses and Midwives Council of Malawi (NMCM) and the Medical Council of Malawi (MCM).

The Statistical Support Unit supports research groups at MLW through statistical consultancy, brings together and trains biostatisticians at MLW and conducts statistical methodological research. Specifically the unit:

1. Provides statistical support to MLW research groups.

2.  Engage in applied statistical methodological research through extending existing or developing new methodology to answer relevant biomedical research questions.

3. Train MLW researchers in statistical methods for study design and data analysis.

4. Train the next generation of Malawian biostatisticians.

5. Engage with the statistics community in Malawi.

To provide high quality, Good Clinical Laboratory Practice (GCLP) and ISO 15189 compliant, clinically relevant, and timely laboratory support to all Programme research activities and clinical services as required.

The MLW laboratories are centrally managed. Innovation is encouraged in both the diagnostic and experimental laboratories. Substantial successes include the complete refurbishment of the main laboratory building, opening of a large CL3 containment laboratory for TB diagnostics at COM site and a small CL3 laboratory for mechanistic work at MLW site, upgrading of flow cytometry and acquisition of cell-sorting capacity.

The MLW Core Laboratory was first established in 1995 to do malaria slide reading and packed cell volume (PCV) and a limited blood and cerebral spinal fluid (CSF) culture service. Since 1995 the department has grown in response to increasing number of research projects and the need to cover a wider range of tests.

From 2007 the Core laboratory was re-organised to reflect how the laboratory had evolved as the Programme has grown: separate Microbiology, Blood Sciences (haematology and biochemistry), Molecular and Parasitology sections have formed with a senior laboratory technician responsible for the daily running of each section. Centralised specimen archiving and shipping was also established.

As quality plays a critical role in the laboratory a Quality Assurance section was established and given oversight of all laboratory quality issues (core and project), including IQC, EQA, document control and audits and works closely with the Laboratory Management Team and other operational departments to improve quality within the laboratory and attain ISO15189:2012 accreditation.

The Laboratory Manager, together with the Laboratory Steering Committee, is responsible for overseeing the strategy and ensuring the quality of all project and core work based within the laboratory.

The Data Management Support Unit’s (DMSU) primary role is to support researchers through the research life cycle, focusing on the data life cycle, so that they have complete, accurate and timely data according to the agreed data management plan.

To achieve this and ensure a high level of quality throughout the research data life cycle, we make use of standard software tools, processes, and procedures, that have been informed by internationally accepted best practices, standards, rules and regulations AND local legislation.

By doing so we are supporting MLW’s core mission of conducting internationally excellent research to benefit health and training the next generation of researchers.

We provide an end-to-end service – from the development of the data collection instruments through to the long-term digital archiving, and sharing, of the generated data sets – to MLW research projects.

The DMSU Lead oversees the department’s work and  is supported by skilled & experienced team of data managers, software developer, data officers, translators and subscribers .

The DMSU lead is supported by the Data Management Steering Committee in setting the strategic direction of the DMSU.

More information about the data department is available at https://data.mlw.mw