• IRB
• Minimum Training
• Clinical Research Management System (CRMS)
• Compliance – DNC/SAE/PISAF*
• Quality – Monitoring and Audit*
*To be rolled out later.
All new IRB applications will be managed via ECOS following its official launch, tentatively set in May 2024. Existing on-going studies will also be migrated from iSHaRe to ECOS. The completion date is to be confirmed.
Minimum Training
Researchers who conduct Human Subject Research must meet the minimum requirements stipulated.
Researchers would be required to submit their minimum training certifications under the User Profile page. After submission, the institution's Minimum Training Secretariat would complete the check and issue the researchers with the label of the type of studies that the researchers can conduct. The table below shows the training certifications required for the different type of studies.
Clinical Research Management System (CRMS)
Researchers can utilise this new research toolkit to record, plan and track the administrative activities of a clinical research study, e.g. regulatory authority submissions and outcomes, key contact personnel, funding and agreement information, milestones achieved, recruitment progress, research participant status and visit planning. The CRMS module also functions as a user management system to control the access of Study Team Members, Study Administrators and Study Sponsors to the IRB module. Data entered in the CRMS can be extracted for trending and reporting purposes at the site, study, department, institution and/or cluster level. Researchers are strongly encouraged to take full advantage of this module to maintain a good oversight of their clinical research projects.
Compliance*
For research regulated under the scope of Human Biomedical Research Act (HBRA), Suspected Offences or Contraventions (SOC) and Serious Adverse Events (SAE) shall be reported to MOH. Deviation/Non-Compliance (DNC) and Serious Adverse Events (SAE) that are reported to the IRB will also be reviewed in the Compliance module. If the event is reportable to MOH, the MOH reporting forms will be triggered for completion in ECOS.
For research conducted in SingHealth, the PI Self-Assessment Form for PI to assess the extent of compliance in accordance to required law, regulations and institution policies will be completed in ECOS.
Quality (Monitoring and Audit) *
The Quality module incorporates the Monitoring and Audit functions. With this module available on ECOS, Monitoring and Audit process workflows to be carried out by the relevant individuals involved in the monitoring/auditing of the research. Activities like visit planning/confirmation, monitoring plan and monitoring/audit report generation, as well as monitoring/audit findings and follow-up can all be done on one platform.
