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If a non-serious AE becomes serious, it should be recorded as AE

Dr Arun Bhatt
Wednesday, July 3, 2024, 08:00 Hrs  [IST]

In one participant headache which was mild, became moderate after a day and was mild next day. How do we record an adverse event (AE) in the case record form, when severity change, or seriousness change occurs during the course of AE?
Dr Paresh Shah

Headache seems to be an adverse event of variable severity. However, the clinical assessment of the investigator would be useful in clarifying the symptoms. Headache could be part of another condition e.g. migraine, nervous system problem or may be associated with hypertension. Depending on the assessment of the investigator, the reporting of adverse event may change. Also, it’s important to check the protocol regarding how adverse event should be reported. The sponsor may provide specific guidance for adverse event reporting. In case this pattern recurs, the investigator should ask the sponsor to clearly articulate standards for adverse event reporting to ensure consistency in reporting of headaches across sites.

If a non-serious adverse event  becomes serious, it should be recorded as adverse event initially in CRF, and later recorded as serious adverse event, and reported as per regulatory requirements.

If there is a discrepancy or issue on Informed Consent Form (ICF) signature or date, could we document the clarification/correction directly on the ICF e.g. a note at bottom of the page?
Udit Jhalani

There are several ways to mange a deviation on the informed consent process.
If the participant signed the Informed Consent Form but entered incorrect date, one could request the participant to sign a new ICF or request the participant to cross out the incorrect date, enter the correct date, and initial and date the change. A note on this on the original ICF may raise concerns from the ethics committee or the auditor/regulatory inspector that the ICF were altered. In both cases a note-to-file is essential in explaining why there were multiple consent forms signed by the same participant or why the original consent form was corrected.

We are conducting a clinical trial in which the window of screening visit in the protocol is limited to 28 days. In our small-town imaging centre appointments for MRI would not be available in 28 days’ time. Could we take appointments for MRI in advance for the visit 1?
Ankita Marwah

GCP guidelines recommend that the investigator should provide the prospective participant/LAR sufficient time and opportunity to consider whether to participate in the trial and should minimize the possibility of coercion or undue influence.

If appointment for MRI is before the potential participant has signed the informed consent, this could increase the possibility of coercion or undue influence. Potential participant may feel that he/she must participate in the trial because of the scheduled MRI appointments. The participant should not experience pressure to participate in a trial because MRI appointment has already been scheduled. If you wish to schedule MRI appointments prior to obtaining informed consent from potential participant, you should request the Ethics Committee to review this specific need and obtain its approval.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

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