SuRE
Supporting Research Excellence
Aim
SuRE aims to support and strengthen research in South Africa and the region through provision of a range of research support services for both clinical trials, non-clinical research, market research and health systems strengthening activities tailored to a client’s needs.
The SuRE team is comprised of highly skilled team members who have extensive experience spanning a range of research, including clinical, qualitative, quantitative, operations, surveys and behavioural studies spanning a range of health areas and interventions.
Clinical monitoring and support
Our accredited Clinical Research Associates (CRAs), have current GCP and ethics certifications and are members of the South African Clinical Research Association (SACRA).
Our support spans the life of the research project and can include a range of start-up procedures, project implementation and close-out activities. All monitoring activities will follow the International Conference of Harmonisation Good Clinical Practice Guidelines (ICH-GCP E6), South African Good Clinical Practice Guidelines (SA-GCP), local regulations and the Wits MRU monitoring Standard Operating Procedures (SOPs). The Wits MRU Monitoring (or SURE) Team assigns a dedicated individual or team to each study/project, working closely with the client to develop a project-specific plan ensuring that activities are delivered on time and within budget.
Specifically, we provide the following support for both clinical and non-clinical trials:-.
Study start up activities
- Trial/study setup (ethics and regulatory submission support),
- Protocol review
- Development of questionnaires/Case Report Forms (CRFs) (electronic database/surveys/paper)
- Development of Standard Operating Procedures (SOPs),
- Assist with creating essential documentation for study start-up,
- Setting up the Investigator Site File
- Site initiation procedures,
- Logistics,
- Setting up Study Files
- Training of data collectors/research team
During the study
- Regular monitoring,
- Support for protocol amendments,
- Assist with creating essential documents during the study,
- Maintaining the Investigator Site File
- Participant verification
Study close out
- Assist with creating essential close-out documents.
- Review of the Investigator Site File
- Archiving
Qualitative research
Our qualitative team can provide the following services:
- Development of topic specific guides
- Training in focus groups discussions (FGDs) and in-depth interviews (IDIs) techniques
- Transcription and translation services
- Developing codes and transcripts coding
- Qualitative write up and analysis
Health systems strengthening
- Monitoring of service data collection
- Data quality checking
Data management service
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Our data team can support the following activities:-
- Building REDCap databases for data entry (direct and indirect), online surveys, management of qualitative data
- REDCap user training
- Data entry management, query resolution
- Data quality checking
