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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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