Thank you so much @jennifer-carroll for your detailed answer! I’ll probably send an email then with the eFile number and additional details soon.
A
Ayca
@Ayca
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Posts
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Multiple gated HCP Sites on the same corporate platform -
Multiple gated HCP Sites on the same corporate platformHello, I’m currently working on creating a gated (2) website exclusively for HCPs to support a specific product. This new gated site would be hosted on the same corporate site as another gated HCP website that is already live but relates to a different product. The existing gated (1) site was previously validated by PAAB.
We want to create and submit this second gated HCP site (2) for PAAB approval. My two questions are:
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Since both gated sites would be hosted on the same corporate website, does the corporate site need to be submitted again for review? For context, when we initially submitted the first gated HCP site (1) for PAAB approval, we were required to submit the corporate site as part of the process, and changes were made at the time to meet compliance standards. However, the corporate site hasn’t been modified since then.
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If we submit the second gated site for PAAB approval, does the first gated site also need to be included in the process or validated again? Even though the first site relates to a different product and its PAAB approval might not be renewed, it shares the same corporate website as the second gated site.
Basically, I want to understand whether hosting two different gated HCP sites on the same corporate site introduces any additional requirements, particularly around "revalidating" the corporate site or the first gated site, which might not be renewed.
Thank you so much for your help!
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Patient Consent FormsThank you so much for your answer! @jennifer-carroll
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Patient Consent FormsHello!
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!