312 - What are the steps to review and approved a website? Does the content of the site may be revised first as independent, indicating the titles subtitles, main menu, submenu, boutons, etc..? And then once approved texts, we submit the entire site with images of each page and approuved content. Or should we submit from the first revision the entire website as one ASP needed to be revised with images of the design which will present content that not approuved?
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The PAAB cannot review off a live site. Therefore, the submission must clearly/fully describe all electronic functionalities. Generally speaking, if both languages are to be produced, we will review the English copy and layout and then ask for French translation. The initial submission should include: a site map and wireframe a layout (if a layout cannot be provided at initial submission, a detailed wireframe must be provided). description of gating mechanism where relevant identification of all intra-site links and company/agent generated external links that direct to and away from the website (e.g. search engine marketing, banner ads, other websites, etc.); the site rules and monitoring/moderating policy (if the website offers user generated content functionality) keyword metatags and metadescriptors for search engine optimization (if the client is setting these). If the website is large, split the site into modules (within the same eFile) which fit the system maximum document size of 20 MB. The file name for each module should correspond to the same numbering scheme used in the provided site map. The layout requirement can generally be addressed by screen shots once the piece is near copy approval. The following parts of a website are required to be separated into different eFiles: Segments of a website which are targeted for different regulatory audiences (i.e. HCP vs patient vs consumer) Exception: The landing page on an HCP/patient website is accessible to the general public, but it may be submitted in the same eFile as the HCP/patient website Sections of a website pertaining to different products e.g. in a gated portion of company X's corporate site, there is a section for drug ABC advertising, a section for drug DEF advertising, and a section for drug GHI advertising. The section for ABC, DEF, and GHI should be submitted separately Standardized correspondences generated through participation in activities through the site (e.g. email/text messages) Documents available for download which are created by (or influenced by) the manufacturer/agent e.g. dose cards, product brochures, newsletters
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Requesting clarification on "Documents available for download" as a separate submission: if I have a video that is ONLY available from a website, is the video a separate submission? Or can it be part of the same submission?
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Hey @AnetteCPC
Multiple factors can potentially come into play. But the most frequent determinant tends to be whether the video is embedded in the website and is ONLY accessible on the submitted website page, then it can be submitted as part of the same review. If the video can be downloaded, shared or in some way consumed where it is not on the reviewed webpage and complete website, it requires a separate submission. Remember that APS are reviewed as a whole as there may be content on the page or website which creates context for the video, which the video alone may not contain.
