Response Documents/Response to Questions (RtQ)

A Response to Questions (RtQ) document contains answers to any questions raised by the health authority during their review of the evidence provided in the application dossier. The purpose of the RtQ is to provide clarifications on the content of the initial submission or to submit additional analyses to address the questions.

 

Different types of questions can be expected from easy (simple to answer) to more complex (requiring team input/discussion to answer). Regional differences exist in how and when questions are issued by the regulators as well as in when written responses to these questions are due.

 

Once questions from the health authority are received, written responses should be focused on the information being requested and must be provided within the specified timeframe. It is therefore useful to form a response team (including representatives from all relevant functions) shortly after submission of the application dossier. This team proactively determines any issues (to be anticipated) or any known weaknesses of the application dossier and starts preparing the possible questions.

 

Medical Writers can have a coordinating role during the document development process (eg, tracking responses to questions, compiling contributions, ensuring consistency between responses) and can help draft responses to clinical questions.

 

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