The sponsor is a company, institution, or organisation that takes responsibility for the initiation, management and/or financing of a clinical trial.

The sponsor is responsible to implement and maintain quality assurance and quality control systems to ensure that clinical trials are conducted in compliance with the protocol, applicable regulations, the principles of GCP and the standard operating procedures relevant to the clinical trial.

The local sponsor should be a locally registered business entity registered with the Accounting and Corporate Regulatory Authority (ACRA) in Singapore.

Regulatory obligations of the local sponsor

The regulatory obligations of the local sponsor are as follows:

• Obtain Clinical Trial Authorisation (CTA), acceptance of Clinical Trial Notification (CTN) or Clinical Trial Certificate (CTC) for the clinical trial
• Obtain approval for, or acceptance of notification of, substantial amendments to the clinical trial
• Ensure that information in the Investigator’s Brochure (IB) is concise, objective and kept up to date
• Ensure that the clinical trial is conducted by or under the oversight of a qualified PI
• Ensure that the clinical trial is conducted at location(s) specified in the clinical trial application
• Carry out the duties and functions of the sponsor, and ensures any person to whom the sponsor has allocated trial-related activities does so in accordance with the principles of Good Clinical Practice (GCP)
• Put and keep in place arrangements to ensure compliance with the principles of GCP
• Ensure appropriate investigational and auxiliary product labelling
• Keep adequate essential records
• Notify us of the trial status (including the suspension, termination and/or conclusion of the trial) within the stipulated timelines
• Notify us of serious breaches within the stipulated timelines
• Notify us of urgent safety measures taken to protect trial participants against immediate hazard within the stipulated timelines
• Report unexpected serious adverse drug reactions and medical devices adverse events within the stipulated timelines
• Submit final report within the stipulated timelines 

The sponsor may transfer any of the above duties and functions to another company, but any such arrangement does not affect the responsibility of the sponsor.

Additional regulatory obligations for multi-sponsor investigator-initiated trials

For multi-sponsor investigator-initiated trials (MS IITs), where the same clinical trial is conducted at more than one local investigator site, the lead sponsor and participating site sponsor(s) have additional regulatory obligations in addition to the sponsor regulatory obligations described above.

The additional regulatory obligations of a lead sponsor are as follows:

• Coordinate all regulatory submissions and notifications to us (e.g. CTA/CTN/CTC applications, amendments, serious breaches, urgent safety measures, unexpected serious adverse drug reactions, trial status reports, final reports, etc)
• Conduct safety evaluation of the investigational product on an ongoing basis during the trial
• Promptly notify all participating site sponsors and all principal investigators of any information or findings that could adversely affect participants’ safety or impact conduct of trial

The additional regulatory obligations of a participating site sponsor are as follows:

• Provide all relevant information to the lead sponsor that is necessary for the lead sponsor to perform trial-related regulatory submissions and notifications to us
• Report immediately to the lead sponsor any serious adverse event (SAE) at the participating site, or any finding that could adversely affect trial participant safety or impact conduct of trial 

Refer to our Guidance on Multi-sponsor Investigator-initiated Trials257 KB for more details.

Requirement for regulatory submissions

All regulatory submissions should be done online via PRISM. The sponsor should have the following credentials before accessing the e-service: 

• CRIS company account
• Corppass or HSA PIN

Sponsor Oversight

The sponsor may transfer its sponsor activities to third parties (e.g., service providers) but retains the overall responsibility for all sponsor activities.

The sponsor should establish agreements with investigators and service providers. The agreements should define the roles, activities and responsibilities for the clinical trial and be documented appropriately prior to initiating the activities.

The sponsor should maintain appropriate oversight of the trial to ensure that the trial design, trial conduct, processes undertaken and the information and data generated are of sufficient quality to ensure reliable trial results, participants' safety and appropriate decision making.

The range and extent of sponsor oversight measures should be:

• fit for purpose; and
• tailored to the complexity of and risks associated with the trial.

The selection and oversight of investigators and service providers are fundamental features of the sponsor oversight process. It includes quality assurance and quality control processes relating to the trial-related activities of investigators and service providers.

Some examples of sponsor oversight include:

• Establishing, implementing and maintaining SOPs
• Ensuring that staff are adequately qualified and trained to perform the trial-related duties and functions
• Performing service provider qualification audits for selection of service providers
• Performing investigator site qualification visits for selection of investigators
• Conducting investigator site monitoring
• Conducting centralised monitoring
• Determining the criteria for important protocol deviations
• Ensuring that decisions related to the trial have been assessed for their impact on the rights, safety and well-being of participants, and the reliability of trial results
• Ensuring appropriate and timely escalation and follow up of issues to allow implementation of actions in a timely manner
• Establishing committees, including:
  • Independent Data Monitoring Committee (IDMC) to assess the progress of a trial, including the safety data and the efficacy endpoints, at intervals and to recommend to the sponsor whether to continue, modify or stop a trial; and/or
  • Endpoint assessment/adjudication committee in certain trials to review endpoints reported by investigators to determine whether the endpoints meet protocol-specified criteria
• Maintaining essential records

Monitoring of clinical trials

Monitoring is one of the principal quality control activities by a sponsor.

The aim of monitoring is to ensure:

• The rights, safety and well-being of participants;
• The reliability of trial results; and
• The trial is conducted in compliance with the protocol, applicable regulations, GCP and standard operating procedures (SOPs).

Monitoring may include the following types of monitoring, depending on the monitoring strategy and the design of the clinical trial:

• Investigator site monitoring, which involves evaluation of the trial-related activities at the investigator site by the Monitor. Investigator site monitoring may be conducted on-site or remotely;
• Centralised monitoring, which involves evaluation of accumulated data, performed in a timely manner, by the sponsor's qualified and trained persons (e.g., medical monitor, data scientist/data manager, biostatistician).

The sponsor should adopt a proportionate, risk-based approach to determine the appropriate extent and nature of monitoring. Factors such as the objective, purpose, design, complexity, blinding, number of trial participants, investigational product, current knowledge of the safety profile and endpoints of the trial should be considered.

The sponsor should develop a monitoring plan that is tailored to the identified potential safety risks, the risks to data quality, and/or other risks to the reliability of the trial results. The monitoring plan should specify the:

• Type of monitoring to be performed
• Factors critical to quality that should be monitored (i.e., attributes of a trial that are fundamental to the protection of participants, the reliability and interpretability of the trial results and the decisions made based on those trial results)
• Monitoring strategy to ensure appropriate oversight of trial conduct and consider site capabilities and the potential burden (including frequency of monitoring, duration of monitoring, source data review (SDR) / source data verification (SDV) plan)
• Monitoring activities to be performed
• Monitoring methods and tools, and rationale for their use
• Applicable sponsor's SOPs to be used

Monitoring involves a broad range of activities including, but not limited to,

• Communication with investigator sites
• Verification of the investigator and investigator site staff qualifications and site resources, training
• Review of essential records and information using a range of approaches including source data review, source data verification, data analytics and visits to institutional facilities undertaking trial-related activities.

Monitoring should be performed by persons not involved in the clinical conduct of the trial at the investigator site being monitored. Thus, the PI and investigator site staff should not monitor their own trial.

Reports of monitoring activities should include:

• A summary of what was reviewed;
• A description of significant findings;
• Conclusions; and
• Actions required to resolve them and follow-up on their resolution including those not resolved in previous reports.

The sponsor should review the monitoring reports in a timely manner, and take appropriate actions on any issues requiring escalation.

Transfer of local sponsorship for ongoing clinical trial

For transfer of local sponsorship for an ongoing clinical trial to another locally registered company, the new local sponsor should submit a new clinical trial application to us.

The new clinical trial application must contain the following:

• All currently-approved study documents as required for a new clinical trial application
• Letter from the current local sponsor indicating transfer of local sponsorship to the new local sponsor. This letter should be copied to the new local sponsor and the respective investigator site PI(s) and IRB(s).

Upon receipt of the approval of the new clinical trial application from the new local sponsor, the current local sponsor should submit a Trial Status Report to indicate the change of local sponsor. This can be done by indicating the trial status as "premature closure" and providing the reason as change of local sponsor. 

Change in contact person

The contact person of the local sponsor is the applicant who had submitted the most recent PRISM application for that clinical trial (excluding safety reports). It is essential to inform us of a change in the contact person, as e-mail reminders for the submission of Trial Status Report are sent to this individual.

The change of local sponsor contact person may be made through the submission of a Trial Status Report or any other application (excluding safety reports). Subsequent regulatory correspondences would thereafter be directed to the new local sponsor contact person after the submission has been processed by us.

Change in company address

The local sponsor may update the new company address through the Amend Company Information module via PRISM, and should inform us via email to HSA_CT@hsa.gov.sg.