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Informed Consent Documents
Education Documents
Document Change and Addition Process
On-Going Document Review


Informed Consent Documents
Informed consent documents are written by members of Dialog Medical's Medical Advisory Board (MAB). The physicians who compose the MAB are all board-certified in their particular specialty. Those physicians prepare consent documents according to exact guidelines developed by Dialog Medical. Following the development of a manuscript document by the MAB Member, the document is reviewed by the Dialog Medical Editorial Manager for style, consistency, medical literacy, grammar, spelling and punctuation. If changes are significant, the document is returned to the MAB member for final concurrence. In many cases the Medical Director of Dialog Medical (a practicing physician), an alternate MAB Member and/or the Content Manager of Dialog Medical will review and contribute to the document. Lastly, the document is submitted to the Dialog Medical Content QA Manager for an independent assessment - if there are any issues with the document, it is returned to the Content Department for reconciliation of the issue(s).

Education Documents
Education documents are written for Dialog Medical by professional Medical Writers. These writers typically develop content for the major consumer websites, for pharmaceutical and medical device companies, and for hospitals. The Medical Writers prepare education documents according to exact guidelines developed by Dialog Medical, including guidelines relating to document readability. The primary object of the patient education documents is to provide a concise and unbiased review of the particular topic. Following the development of a manuscript document by the Medical Writer, the document is reviewed by the Dialog Medical Editorial Manager for style, consistency, grammar, spelling and punctuation. If changes are significant, the document is returned to the Medical Writer for final concurrence. In some cases an alternate Medical Writer, the Medical Director of Dialog Medical (a practicing physician), a MAB member and/or the Content Manager of Dialog Medical review and contribute to the document. Lastly, the document is submitted to the Dialog Medical Content QA Manager for an independent assessment - if there are any issues with the document, it is returned to the Content Department for reconciliation of the issue(s).

Document Change and Addition Process
Dialog Medical has developed a formal process for clients by which they can submit requests for changes to documents or requests for the addition of new documents. Revised documents or new documents, created under the Content Request process, undergo the same processes as those outlined for the development of new documents (see above).

On-Going Document Review
All consent documents and education documents are reviewed on a regular basis (annual, biennial, or triennial) to ensure that they remain reflective of current clinical practice in all respects (drug monographs are reviewed on a monthly basis.) The frequency of the review cycle is established by the MAB Member based on the projected variability of the treatment or procedure. Documents may be reviewed at any time outside of their established review cycle due to the availability of new clinical evidence, the publication of applicable regulatory guidance, or other factors. The document review is conducted by a MAB Member (consent documents) or a Medical Writer (education documents) who is different from the original author of the document to be reviewed. The editorial review process and QA release process, employed with the development of new documents, are also employed for document review.

 

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