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IIT and pharma company input



  • Laure
    21/08/2019 14:20
    Dear GCP forum, What are the regulations regarding IIT and pharma company involvements? Pharma company involvements are usually very limited for IIT but If a pharma company wishes to get and use the data from an IIT study, would the pharma company be allowed (after agreement from the Investigator-sponsor) to perform audits while the study is ongoing (as it's not standard for IITs to have QA input from investigators' side? where Can I find regulations on IIT?
  • Anon
    21/08/2019 14:42
    MHRA GCP Guide 2012 has good information. It is always a difficult line. Many GCP inspectors suspect companies of using IIT as a back door to doing their research. Therfore you have to go to extreme lengths to show that the investigator is the Sponsor.... Just an idea, but as the Sponsor the investigator could ask for an audit from independent auditors.
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