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Principal Investigator

Hi all!!

I would like to know about underwritten.

When you create study you must specify Principal Investigator and then when you create sites you have to point Principal Investigator also. What difference between these notions?

Comments

  • kristiakkristiak Posts: 1,338 ✭✭✭
    via Email
    The site principal investigator can only see and sign data from his own site, while the study principle investigator cannot get the role as an investigator and hence cannot sign any data, although he can be a study director and see all the data but not sign any CRF's

    Regards

    Krister
  • Krister,

    Do you think I can point the sponsor representative as study principle investigator? Is it wrong?
    I have a discussion about it because if I have a multicentre study I will have lots of the site principal investigators. And How can I choose then the one study principle investigator?!
  • kristiakkristiak Posts: 1,338 ✭✭✭
    via Email
    Hi Viktoriya,

    If you have a multicentre study you usually have one investigator who is the leader, e.g. the Steering Committee Chairman if you have one. At each site you will have one investigator who is the main responsible for that site and he thus the site primary investigator, he is usually the one who signed the protocol. The sponsor is usually NOT the primary investigator since they would want to be independent and not primarily involved.

    Regards

    Krister
  • Thank's! I see.
This discussion has been closed.