Patient Consent Forms
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Hello!
A company is considering including additional fields in an enrollment/patient consent form for a Patient Support Program to gather anonymized data, such as treatment-naïve status or switching treatments. Before proceeding, I wanted to have clarification on whether it is possible to include such data of interest in a patient consent form that will not be used for any study.
Are there specific guidelines or requirements to follow for compliance, particularly regarding data use and patient confidentiality?
Thank you so much!
-
Hello!
A company is considering including additional fields in an enrollment/patient consent form for a Patient Support Program to gather anonymized data, such as treatment-naïve status or switching treatments. Before proceeding, I wanted to have clarification on whether it is possible to include such data of interest in a patient consent form that will not be used for any study.
Are there specific guidelines or requirements to follow for compliance, particularly regarding data use and patient confidentiality?
Thank you so much!
Hi @ayca,
In general, information collected on enrollment forms should align with the TMA indication. PAAB reviews the additional fields in relation to the TMA and overall intent of the APS. For example, drug A is only indicated in a population of patients with condition X, who are pharmacologically treatment-naïve. In cases where the fields suggest a contradiction to the on-label indication e.g. collecting previous treatment information for the condition, PAAB will question their inclusion in adherence with section 9.1 of the Food and Drugs Act. We also advise you to consult your legal department regarding the laws of patient personal health information collection and patient confidentiality.”
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Hi @ayca,
In general, information collected on enrollment forms should align with the TMA indication. PAAB reviews the additional fields in relation to the TMA and overall intent of the APS. For example, drug A is only indicated in a population of patients with condition X, who are pharmacologically treatment-naïve. In cases where the fields suggest a contradiction to the on-label indication e.g. collecting previous treatment information for the condition, PAAB will question their inclusion in adherence with section 9.1 of the Food and Drugs Act. We also advise you to consult your legal department regarding the laws of patient personal health information collection and patient confidentiality.”
Thank you so much for your answer! @jennifer-carroll
