The study start-up process begins with the planning of a research study and designing the research protocol. To conduct a research study, it requires processes from various functions to start the study properly. This is to ensure that ethics, regulatory and institution expectations are met for the conduct of research.
The diagram below shows the various processes that lead to the initiation of the research.
The Human Subject Research Start-Up course is intended for Investigators, Researchers and any individual intending to conduct or be involved in Clinical Research involving human subjects. It will equip learners with essential information and key elements to plan start-up, carry out pre-study activities and initiate a Human Subject Research successfully. After completing the course, learners will be able to download a certificate of completion. This course is optional but strongly encouraged for all researchers involved in a Human Subject Research.
The self-registration course can be assessed from the SingHealth eLearning portal by clicking here.
For staff who is logging into the system for the first time, the default login credentials will be:• LoginID: Windows UserID (ADID) • Default Password: LMS2019 followed by your ADID in lower case (e.g. LMS2019xxxx where xxxx is your ADID) Please do not include the domain (e.g. singhealth/shhq/kkhad/sghad/shsc/etc) in front of the UserID.
If you have forgotten your password or have problem logging in with your password, please use the "Reset Password" function, or contact LMS Helpdesk for assistance.
The links below will help researchers determine whether their study is considered research under the applicable regulatory requirement.
Differentiating Research from Service Evaluation, Clinical Audit, Surveillance and Outbreak Investigation
Checklist for QA/SI (Intranet Only)
Type of Study Determination Form
The intent of research is to develop generalisable new knowledge systematically.
• If the project is not considered a research, it will have to follow the PDPA and institution's policies.
Scope of Human Biomedical Research Act (HBRA)
• Research will fall within scope of the HBRA if it satisfies at least one Purposive element and one Methodological element or where it involves Sensitive research.
• Research involving the use of individually identifiable health information/human issue where it also meets the Purposive element (e.g. the prevention, prognostication, diagnosis or alleviation of any disease, disorder or injury affecting the human body) will be regulated under HBRA.
• Clinical trial involving the use of investigational drug falls out of scope of the HBRA.
Obtaining Consent
• Appropriate consent has to obtained in accordance to HBRA for a HBR study.
• Waiver of consent may be approved by the IRB if the study meets the criteria for a waiver.
Research Process and Study Workflow: SHS-RSH-CTCC-CWP-201 (Intranet Only)
