groups » Training and Continued Professional Development » Documenting our Q & A's whilst doing the study protocol

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protocol study

  • brendawright Brenda Wright 8 Jan 2015

    I think the detail of the protocol is often not used appropriately when conducting a clinical trial. i.e. we use our source documents as guidelines to gather information, but we do not always pay attention to the detail we are recording on the source document and therefor maybe miss inclusion/exclusion criteria, specific procedures or methods etc.

    It is vital that the study team know their protocol before, during and after the conduct of the trial and this means having the protocol on hand at all times to refer to, check detail etc.

    Training of study staff is vitally important, and includes reminding them of the protocol and prompting them to check details

  • Based on the completing the course I had a couple of questions:

    1. When you are on a multi-centre study what questions do you need to ask the sponsor that ensures that ‘accurate and detailed instructions of how all the measurements are to be made must be given to the protocol user, so that all observations are done in a standard way across all participating centres’?

    2.Please can you explain the meaning of this statement when relating to blinding, "It is less important for objective outcome measures, such as death, when there is little scope for detection bias."

    3.At a start up meeting is it worth asking how the sample size was calculated i an environment where recruitment is a challenge and how do you go about doing this?

    4.How does one go about outlining the strengths and weakness within a protocol?

    5.Question 5's answer was a challenge to me.

  • A website which contains more information on systematic reviews :-
    http://www.prisma-statement.org

    Interesting info from BMJ about the update to the Declaration of Helsinki:-

    Revision of Helsinki declaration aims to prevent exploitation of study participants
    BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f6401 (Published 22 October 2013)
    Cite this as: BMJ 2013;347:f6401

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