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[D3] Can a doctor who has a conditional registration with Singapore Medical Council (SMC) be a Principal Investigator (PI) of a clinical trial?

[D4] What is the minimum training required for Principal Investigators (PIs)?

[A1] What are the regulatory requirements for clinical trials in Singapore?

[A2] How can I determine if my clinical trial requires Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN) or a Clinical Trial Certificate (CTC)?

[E3] If the study staff has been trained in the Singapore Guideline for Good Clinical Practice (SGGCP), do they need to be re-trained in the ICH E6 GCP after the port over of the clinical trials regulations?

[E4] If there is a change of Principal Investigator (PI) for a clinical trial, how can this change be documented on the Signature Sheet?

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[H6] For clinical trials in adults lacking capacity where there is a donee for the adult lacking capacity, does the investigator need to ascertain whether the donee has been authorised to give consent for clinical trial participation?

[D5] What should be done when the Principal Investigator (PI) is on extended leave?

[D6] If the Principal Investigator (PI) of a suspended / terminated / completed clinical trial has resigned, is there a need to submit an amendment application for Change of PI to HSA?

[G1] What kind of study amendments should be submitted to HSA?

[G2] Although it is the sponsor’s responsibility to assess whether an amendment is regarded as a substantial amendment, does a lead sponsor need to consult the participating sponsors on the assessment for multi-sponsor Investigator-initiated trials (MS IITs)?

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