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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 submission of the comment are described below and in the "Template for a comment". The template for a comment can be found on the webpage of the project on which a hearing is being held.

Overview of the requirements for the submission of comments

• Eligible participants: Anyone who has an interest in a particular assessment can comment on the documents in the hearing procedure, i.e. so-called natural persons (= private persons) and legal persons (= companies, institutions and commercial enterprises). In the case of legal persons, the person or persons submitting comments must also indicate their names.
• Form of the comment: Comments must be submitted to IQWiG in writing, in German, and before the deadline. Further information on the form of the comment and on data protection aspects can be found in the “Template for a comment” (see link below). Besides the comment itself, the full texts of the literature cited in the comment have to be submitted to IQWiG before the deadline in order for the comment to be considered. Further information is provided in the “Template for a comment” (see link below).
  
• Submission of the comment: Please submit the comment-related documents to IQWiG preferably by e-mail (berichte@iqwig.de) and ideally as a PDF file, and include the project number and the document type in the reference line of the e-mail (e.g. Re: Comment on preliminary report S19-01).
  In exceptional cases, the comment can also be sent 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 project that is subject to the hearing. The exact deadlines are published on the IQWiG homepage and on the relevant project webpage. The date and time of receipt of the documents by IQWiG are decisive for the timely submission of a comment.
• Debate: If questions remain after IQWiG’s evaluation of the comments, the Institute can optionally hold an oral debate. Only those persons are allowed to participate who submitted a written comment. The date of the oral debate is disclosed on the project webpage (see data sheet “Timetable”). The debate is recorded by IQWiG with the involvement of a minute-taker from the North Rhine-Westphalian state parliament, and the verbatim record is published on the project webpage in the document "Documentation of the hearing".
• Publication by IQWiG: The comments are published in full on IQWiG's website in the "Documentation of the hearing on the [report plan/preliminary report/preliminary basic report]", together with the names of the persons submitting the comments and, if applicable, of the institution. The marked section on the cover page ("Contact details") and accompanying letters on comments (e.g. e-mails or letters) are not published. Further details on the publication of comments can be found in the "Template for a comment" as well as in the document "Information on data protection".