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Inspection Logistics: Capturing, Clarifying, and Communicating Requests

This week we’re focusing on common inspection challenges.  Today’s topic:  Capturing, clarifying, and communicating requests. 

This process appears deceptively simple.  The inspector requests a document; someone writes it down and communicates it to the person who will retrieve the requested document. Any number of tools would seem to do the trick – a shared document, chat client, even pen and paper.  The challenge is the game of “telephone” that can ensue when the person capturing the request (we’ll use the term Communicator) doesn’t clearly communicate its intent.  Miscommunications may occur when

  • The Communicator transcribes the request verbatim, but the terms the inspector uses are not the terms the back room understands.  For example, the inspector may ask for the “validation plan,” but the team uses the term Edit Checks Specification for this concept.
  • The request makes sense in the context of the broader discussion, but the back room staff do not have access to that context. For example, in the context of a discussion about testing the EDC system, the inspector asks for the “validation plan,” but the back room team assumes that the request concerns the data validation plan.
  • The request is not detailed enough. For example, the inspector asks for the “validation plan,” but the back room team does not know if the validation plan for the core or configured system is being requested.

Obviously, it’s not enough to capture and communicate requests.  Clarification is key.

Some inspection teams mitigate this risk by having a very knowledgeable Subject Matter Expert (SME) act as the Communicator for the inspection.  For a GCP inspection, for example, the Communicator might be the Clinical Trial Manager for the study – someone who knows the study, its terminology, and even the document locations inside and out.  A Communicator with this knowledge would know when to ask for clarification and might even be able to include instructions to the back room on where to find the requested document.

Other inspection teams prefer to have their key SMEs in the back room, pulling documents, and fill the Communicator role with a person who is knowledgeable about the inspection scope, but is assigned to a different team – for example, a Clinical Trial Manager on a different program that will be conducting inspection readiness activities in the upcoming year. A Communicator with this skill set will still be good at clarifying questions and also gets exposure to the kinds of questions their program needs to be prepared to answer.

Still other inspection teams put someone who is a fast typist in this role, and then rely on the Host or another SME in the inspection room to clarify questions with the inspector and dictate the text of the request.

In any case, the inspection team must define who is responsible for clarifying questions with the inspector (for example, the Communicator, the Host, or the SME being interviewed), as well as the communication path if someone in the inspection room other than the “clarifier” realizes that a clarification is needed.

After defining that path, a good way to practice clarifying questions is to have a mock inspector practice asking vague questions. If the assigned team member fails to clarify a question, the request will get to the back room, which will either misunderstand the request and fulfill it incorrectly, or bounce it back to the front room for clarification.  After a few rounds of that, the front room personnel will not let a request through until they are certain they understand it fully.

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