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1. Pre-Study Activities

Researchers are to plan for a minimum of 3 to 6 months to carry out the pre-study activities. For HBR or clinical trials where further regulatory processes are required, the timeline may increase. It is important to consider these pre-study processes carefully otherwise it can result in institution or regulatory non-compliance, e.g. no applying for a Clinical Trial Authorization (CTA) from the Health Sciences Authority (HSA) for a clinical trial.    

Multi-site considerations for a HBR/Clinical Trial

• For HBR, the multi-RI HBR involves the implementation of the same research protocol at 2 or more independent investigational sites (under different Research Institutions). The Lead Research Institution (RI) is to coordinate the common HBR conducted in a multi-RI research.

• For cross cluster HBR, the individual RI will still be responsible for the supervision and control of the HBR conducted under its auspices, such as the duties of reporting unexpected serious adverse events, suspected offences or contraventions.

• For drug trials (IIT), multiple sponsors (i.e. each institution sponsoring for their own trial sites) for a single protocol are allowed but a lead sponsor will have to be nominated.

• For any research institution that wish to appoint SingHealth as the Research Institution under the regulation of HRBRA, please contact oric@singhealth.com.sg  

Finalization of Study Protocol and Informed Consent Form

• Important study documents such as the study protocol and the informed consent form needs to be customized accurately before these are submitted to the IRB/regulatory for approval.

• The informed consent form must accurately describe the study protocol/procedures and Investigator Brochure (IB).  It must accurately include information/explanations according to the essential elements (eg. HBRA section 12 or ICH-GCP 4.8.10 – (a) to (t)). It should contain a unique version footer <Insert Version No - Version Date>.

• The study protocol should consider the level of safety monitoring and if a Data Safety Monitoring Board is required.

Incidental Findings

• For a HBR, it is important to inform the participant during the informed consent process, if he/she wish to be informed in the event of an incidental finding. The participant have a choice to indicate "Yes" or "No" on the informed consent form. Where there are no plans to inform the participant of incidental findings, this information must also be stated in the informed consent form and discussed during the informed consent discussion.

Study Agreements/Contracts/Research Agreements

It is important to start negotiation of the study agreements early at the study set-up stage. Researchers are to contact their respective institution’s research office.

IRB and Regulatory (HSA/MOH) Submission

• The research study must be submitted for IRB approval and HSA/MOH approval (where applicable). Approval has to be received before initiation of the research.

• For Medical Device studies, a Clinical Research Material (CRM) from HSA may be required.

Tissue Banking Activities

• Investigators should determine if the study is a Research Tissue Banking protocol. A Research Tissue Banking protocol is required to be regulated under Human Tissue Framework (HTF).

• For setting up of Research Tissue Bank, refer to For Researchers> Research Tissue Banking.

2. Study Initiation

A research can only be initiated after the following are in place:

• IRB approval.

• Regulatory (HSA/MOH) approval (where applicable).

• Signed study agreements/contracts.

• Study logistics (eg. study drugs/device/lab supplies etc) and manpower.

If the study is not set up properly, it may result in non-compliance and protocol deviations during the conduct of the study which requires reporting to the IRB and/or authorities.

3. Study Conduct

Study/Protocol Specific Training

• PI to ensure that study team members are trained on the protocol and study procedures. Training documentation are required.

Informed Consent Process

• Ensure the informed consent form used for obtaining consent has been approved by IRB/HSA (where applicable).  Check the footer version and date against the study's IRB/(HSA where applicable) approval letter.

• Do not use unapproved versions or superseded versions. Use of unapproved or superseded versions are non-compliant. 

• Ensure informed consent is obtained prior to performing any study specific procedures. Study questionnaires are also considered study specific procedures.

• Ensure the consent form is signed and dated personally by the subject him/herself.

• Ensure documentation of the consent process and study participation in the subject's medical records.

• Ensure all persons conducting the informed consent are authorized according to Delegation Log/IRB study team list.

• When a witness is present, ensure the witness understands the language in which the informed consent is conducted.

Data Management and Research Data Breach

• Source data are considered as information in original records and certified copies of original records of clinical findings, observations, or other activities necessary for reconstruction and evaluation of the study.

• All data collected in a research must have a corresponding source data.

• Research data can be collected on a paper source or in Electronic Data Capture (EDC) systems such as RedCap.   

• For your own HBR study or clinical trial, it is important to disseminate the research data by masking or removing the identifiers, where the record linkage key is kept with the investigator.

• For any research data breach, the SingHealth has to be followed. This event is also a non compliance which requires reporting to the IRB, ORIC  and Institution's Research Office. Data Breach policy

Safety and Non-Compliance

• Serious adverse events and non-compliances arising from the research has to be reported to the IRB and regulatory authorities (where applicable).

• Timelines for reporting must be adhered to.

Monitoring, Audits and Inspections

• Any research that has been reviewed by IRB may be monitored, audited internally or by sponsors, or inspected by regulatory authorities at any time during the conduct of the study.

• Audits or inspection may also be carried out after the study closure during the study archival period.

4. Study Closure

• The study is considered completed if there are no more research activities such as contact with the subject.

• The PI is required to provide a study closure report to the IRB. Once the study is closed, no further data collection will be allowed.

• For non-clinical trial type research, data should be archived for a minimum of 7 years after completion of the research study. For clinical trials, the duration is at least 15 years or as agreed with the sponsor.

5. PI Self-assessment Form

All PIs are required to use the form to perform self-assessment on their own studies conducted. Self-declaration may need to be submitted to SingHealth when required.

Resources and Templates

Forms and Templates