06-05-2018 minutes

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Attendees Anya, Sue, Jen, Christy, Tania


  • Rick was going to help Sue to work on getting public feedback
  • NSDRG Experiences
    • Last week we spoke about identifying who does what in the SDRG do we need to identify where the data came from and the outcome was is that information we want to provide and is the FDA asking the answer was no?
    • But it may be easier if there was traceability
    • Signature page in the SDRG
    • Sue- We’ve had no request from our quality group
    • It also means extra work
    • Jen- We do have a signature page so that when we have an onsite inspection we can show that the study director is the key point of contact for the study
    • Tania – Covance do not have a signature page it was decided in the begging that we were not going to – The study director not involved
    • Christy – we don’t consider it to be a part of the study directors responsibility
    • Abreve – We want to demonstrate that we have the study director involved at all stages we start on some of our data sets before the study is signed off
    • Sue- Some operational people are asking if the study directors approve that the data sets that we created are the right ones
    • There are different rules between nonclinical and clinical for study conduct


  • NSDRG is one way to document the study director’s involvement
    • FDA reviewer comments – the scope of the NSDRG
    • FDA are used to the idea of the reviewer’s guide and are using it to communicate more information than we intended
    • It is becoming a short cut to looking into certain things in the send data set and reading the report which was not the intent
    • Should we bring this up with FDA?
    • We don’t want the NSDRG to be an appendix to the report
    • Comments from the fit for use pilot which is now two years old would they still agree with what they said or would there be more comments?
    • We still do not know how define was used we are not getting the feedback we need on this


  • Should we address define validation issues in the NSDRG – who are the stakeholders of the NSDRG?
    • The reviewers do not use refine
    • The reviewers are the stakeholders of the NSDRG
    • Did we extend the stakeholders to OCS?
    • Could we make a flow chart of out thought process to give to patty to see if she can find out what happens with define
    • This is a big issue and we need to understand what’s useful and what isn’t
    • We want to know how important the code lists and what they are used for
    • Elaine had mentioned that she thought the reason we were not getting comments was because people are still learning but it doesn’t help people who are ready to further their development
    • Steve – We need to work out what the expectations are for define
    • The errors could be explained and added to the guidance
    • There are no validation rules on the FDA website related to define
    • Could we invite someone from clinical to make a presentation on the use of define
    • Pinnacle 21 Webinar who was talking about define which was very clinical related