Ethics and Compliance Online System

Jointly developed by SingHealth and NHG, the Ethics and Compliance Online System (ECOS) is a one-stop solution to support the research lifecycle from Study Initiation to Completion, enabling a more efficient management of research portfolios and ethics applications. This internet-based platform replaces the iSHaRe Institutional Review Board (IRB) system and is accessible to both internal and external users. The ECOS includes the following modules:

IRB
Minimum Training
Clinical Research Management System (CRMS)
Compliance – Deviations & Non-Compliances (DNC) / Serious Adverse Events (SAE)
Compliance – PI Self-Assessment Form (PISAF)
Quality – Monitoring and Audit

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.

Account Registration

New users must register for an ECOS account before they can access the system. The account registration guide is available.

IRB

All new IRB applications will be managed via ECOS following its official launch. Existing ongoing studies will also be migrated from iSHaRe to ECOS. The completion date is to be confirmed.

For more information, please click here for IRB Submissions and here for IRB Resources.

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 the 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 CRMS and/or 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. Please click here for CRMS resources.

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. Deviations & Non-Compliances (DNC) and SAEs 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 (PISAF) for PI to assess the extent of compliance in accordance to required law, regulations and institution policies will be completed on 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 will be carried out by the relevant individuals involved in the monitoring/auditing of the research. Related activities such as 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.

ECOS-Related Training Materials

The SingHealth Research Integrity, Compliance and Ethics (RICE) hosted a series of trainings in preparation for the launch of ECOS.

The New IRB Application Form and Minimum Training Requirements

Click on the link to access the training slides.

Navigating the Ethics & Compliance Online System (ECOS)

Click on the link to access the training slides.

Navigating the Compliance Module: DNC & SAE Review by RI

Click on the link to access the training slides.

Navigating the Monitoring module

Click on the link to access the training slides.

Navigating the PI Self-Assessment Form (PISAF)

Click on the link to access the training slides.

Please click on the following links to access the training resources.

Questions & Answers

Recordings (Kindly note that these are available for SingHealth staff only, please search for training title on the e-learning portal for self-enrolment.)

Questions?

For ECOS-related questions, contact us here.

Ethics and Compliance Online System

Prof Ivy Ng

SingHealth GCEO