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The IQWiG commenting procedure (hearing)

All interested parties can submit comments on intermediate stages of specific IQWiG assessments: on the project outline (report plan) and on preliminary results (preliminary report) of (final) reports, and on the preliminary results of HTA reports at ThemenCheck Medizin (preliminary basic reports). This means, for instance, that you have the possibility to point out further important arguments, studies (in benefit assessments and HTA reports) or guidelines (in guideline synopses) at an early time point. The written commenting procedure including an optional oral debate is called “hearing”.

Your comments must conform to certain formal requirements in order to be considered by the Institute. All important details on the form and process of the commenting procedure can be found on our checklist on the hearing procedure. The relevant forms are available on the webpage of the project for which a hearing procedure has been started.

Overview of the requirements for the submission of comments

• Eligible participants: Everyone who is interested. Participation is open to private persons as well as to societies, institutions and commercial enterprises. In case of societies, institutions and commercial enterprises, the submitting person(s) must state their name(s) and position(s).
• Submission and formal requirements of the comments: Comments must be submitted in writing, in German, and before the deadline. Besides the comment itself, the full texts of the literature cited in the comment and the “Form for submission of written comments” have to be submitted to IQWiG.
  
  In addition, the “Form for disclosure of potential conflicts of interest” should be submitted together with the other documents. This is important for later participation in the optional scientific debate.
  
  In order to meet the deadline, you can send the documents to IQWiG by e-mail (berichte@iqwig.de). The “Form for submission of written comments” must then be submitted in its original version within 5 working days after the deadline.
  
  Submission by post to the following address:
  Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen
  Stellungnahme zum [TYPE OF DOCUMENT AND COMMISSION NUMBER (e.g. “Vorbericht N17-07”)]
  Prof. Dr. med. Jürgen Windeler
  Im Mediapark 8
  50670 Köln
  GERMANY
  
  The Institute will confirm the receipt of the comments sent by e-mail or post.
  
• Deadlines: The deadline for comments starts with the publication of the document that is subject to the hearing. The exact deadlines are published on the IQWiG homepage and on the relevant project webpage.
• Debate: If questions remain after IQWiG’s processing of the comments, the Institute can optionally hold an oral debate. Only those persons are allowed to participate who submitted a written comment and disclosed potential conflicts of interest using the “Form for disclosure of potential conflicts of interest” prior to the debate.