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PD and Queries

Hi all,

I'm just wondering if there's any correlation between Protocol Deviation and the number of queries for the trial.  That is, something like it's about 70% true or probable that a trial has some serious PD going on if it has a large number of queries in a short time frame, say, a month.
Secondly, a trial can have serious PD going on even with very few queries.  Hence, these two observation are not mutually exclusive.

Your input or insight would be highly appreciated.

Don

Comments

  • kristiakkristiak Posts: 1,318 ✭✭✭

    A query that a data manager or a CRA issues does not always mean that there is a protocol deviation. Queries are issued for many different reasons. You may ask for more details, ask for something that is missing ans so on. It dies not have to be a PD. PD's are mostly violations of inclusion and exclusion criteria but could of course be anything. Most queries are issued for clarification. You can avoid many queries by having suitable edit checks in you r CRF but don’t overdo it, the sites will hate you.


    Does this answer your question?

  • cra360cra360 Posts: 56
    Krister,

    "A query that a data manager or a CRA issues does not always mean that there is a protocol deviation. ", fully understood.

    "PD's are mostly violations of inclusion and exclusion criteria but could of course be anything.  Most queries are issued for clarification. You can avoid many queries by having suitable edit checks in you r CRF but don’t overdo it, the sites will hate you.", great insight,
    good to know.

    Thank you.

This discussion has been closed.