Advisory on the Use of Open Text Fields in APS
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Hello!
Hoping to verify how PAAB would like the manufacturer to confirm the two requisite points within this guidance (i.e., (1) representatives will be adequately trained on proper use of open text fields; (2) there is an audit-type mechanism in place to monitor and ensure compliance with this directive):
- Is a Med/Reg letter necessary or is a written statement within the initial cover letter/a subsequent response sufficient?
- Is a list of restricted words required in our submission for review?
As always, thank you for your time in advance.
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Hello!
Hoping to verify how PAAB would like the manufacturer to confirm the two requisite points within this guidance (i.e., (1) representatives will be adequately trained on proper use of open text fields; (2) there is an audit-type mechanism in place to monitor and ensure compliance with this directive):
- Is a Med/Reg letter necessary or is a written statement within the initial cover letter/a subsequent response sufficient?
- Is a list of restricted words required in our submission for review?
As always, thank you for your time in advance.
Happy Friday @palanski
A letter should be provided (a written statement within the initial cover letter or a separate letter) with a written statement confirming both aspects ((1) representatives will be adequately trained on proper use of open text fields; (2) there is an audit-type mechanism in place to monitor and ensure compliance with this directive). As inferred above, yes, this should be uploaded with the initial submission.
As the list of restricted words would not be exhaustive, it is not required as part of the submission.
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@admin your guidance indicates that open text can only be used for personalized greetings or transactional elements (e.g., date and time of a meeting). However can the attachments or content of the email contain PAAB approved materials? For example, my subject line has open text (allowing me to personalize e.g., Hello Dr. Smith, it was nice seeing you yesterday) but my content in the email (not open text) has PAAB approved materials. Is this permissible? Please advise.
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@admin your guidance indicates that open text can only be used for personalized greetings or transactional elements (e.g., date and time of a meeting). However can the attachments or content of the email contain PAAB approved materials? For example, my subject line has open text (allowing me to personalize e.g., Hello Dr. Smith, it was nice seeing you yesterday) but my content in the email (not open text) has PAAB approved materials. Is this permissible? Please advise.
Hi @cea2022
If I’m understanding the question correctly, you are asking if you can put PAAB approved content in the body of the email. If this is a correct understanding, the email, in its totality would require review. Open-text fields are an acceptable part of an email (when meeting the restrictions outlined in the above resource), but the totality of the email still requires review (i.e. the whole email is subject to review). The sponsor cannot generate an email with open-text and previously approved content, at their own discretion and disseminate. The resource Clarification regarding digitization of APS; Helping healthcare product manufacturers plan for the evolving COVID-19 operational context may help provide further context. Specifically, look to the section on “Dissemination”.
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Hi @cea2022
If I’m understanding the question correctly, you are asking if you can put PAAB approved content in the body of the email. If this is a correct understanding, the email, in its totality would require review. Open-text fields are an acceptable part of an email (when meeting the restrictions outlined in the above resource), but the totality of the email still requires review (i.e. the whole email is subject to review). The sponsor cannot generate an email with open-text and previously approved content, at their own discretion and disseminate. The resource Clarification regarding digitization of APS; Helping healthcare product manufacturers plan for the evolving COVID-19 operational context may help provide further context. Specifically, look to the section on “Dissemination”.
@jennifer-carroll Thank you. I will read the additional guidance you have provided.
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@jennifer-carroll Thank you. I will read the additional guidance you have provided.
@admin @Jennifer-Carroll Can you please clarify if having a "blank" open text field for a greeting is acceptable in this respect? I have received conflicting responses from reviewers on the acceptability of such an option.
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@admin @Jennifer-Carroll Can you please clarify if having a "blank" open text field for a greeting is acceptable in this respect? I have received conflicting responses from reviewers on the acceptability of such an option.
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@admin @Jennifer-Carroll Can you please clarify if having a "blank" open text field for a greeting is acceptable in this respect? I have received conflicting responses from reviewers on the acceptability of such an option.
Hey @laraholmes
It’s unclear what “in this respect” is referring to. “Open text fields” are “blank” by definition as the rep determines the copy. The restrictions for open-text fields are that the manufacturer has confirmed the reps are trained to limit open-text to transactional element with no therapeutic, product or service/tool being mentioned (see full advisory above). It may be beneficial to set up a clarification call so that we can better understand your question. Please reach out to admin to set up a call with me.
