Published: 5 March 2026

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Document clinical trial participation in the patient’s medical record

Published: 5 March 2026
Prescriber Update 47(1): 5–6
March 2026

Medsafe recently updated the clinical trial guidelines for industry.^1,2 In the guideline we encourage documenting clinical trial participation in the patient’s medical record.

Documenting the patient’s participation ensures that other health care providers are aware of the patient’s involvement in a clinical trial. It will also provide information that may be relevant for the patient’s medical care. This may be particularly important in situations where trial participants are unable to inform health providers about the trial (eg, in the case of emergency admission to hospital).

Advice for investigators

Investigators should:

• record relevant information about clinical trial participation in the patient’s medical record (or request for it to be added via appropriate channels), including:
  • a clinical trial identifier
  • contact details for the investigator/research team (including out-of-hours)
• inform the patient’s usual health care provider of their participation in a clinical trial, if appropriate.

Advice for health care providers

Health care providers should:

• check that relevant information about clinical trial participation is recorded in the patient’s medical record
• contact the investigator/research team if more information about the study is needed to provide appropriate medical care to the patient
• alert the investigator/research team to hospital admissions or other potential adverse events, if appropriate.

Other points for consideration

• Any information sharing should be part of the informed consent process (note that the patient has the right to decline the sharing of their information).
• Ideally, information about trial participation should be recorded in the electronic medical record so that it is more readily accessible.
• The medical record should be updated when the patient’s participation in the trial is complete.

More information

• National Ethics Advisory Committee: Informed consent in clinical trials

References

1.  Medsafe. 2026. Outcome of the consultation on the proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical Trials 15 January 2026. URL: www.medsafe.govt.nz/consultations/GRTPNZ-ClinicalTrials-Outcome.asp (accessed 23 January 2026).
2. Medsafe. 2026. Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical Trials – Regulatory Approval and Good Clinical Practice Requirements (Edition 3.0). URL: www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Clinical-Trials-Regulatory-Approval-and-GCP-Requirements.pdf (accessed 3 February 2026).