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Hi everyone,
 
im new in making clinical trials.  I am currently a family medicine resident and I would like to make a trial on a non-pharmaceutical method of treating asthma and hyperventilation. our hospital has a good Institutional Review Board that I need to pass before I can start my trials.
 
Going through the courses here at globalhealthtrials I see that I need to make an SOP for my trial.  Unfortunately, I don't have experience making one, I don't even know what one of those look like.  i would like to request someone to share with me his/her SOP manual so I would know what it looks like.  Or please direct me to sites with samples of these things.
 
Thank you so much.
 

  • GHN_Editors The Editorial Team 8 Apr 2013

    Dear Charles

    Thank you for your message. It is really nice to hear from you and to hear about your trial; whereabouts are you based?

    Standard Operating Procedures (SOPs) are documents which clearly explain how to do a step or task, and who is responsible for all the steps within a given task, so that everyone in a team knows how to do this task and can perform it in the same way. So, for example, within data management you would have several different SOPs - one for how to enter data, one for how to deal with queries, one for how to lock the database, and so on.

    SOPs can be updated as necessary, but because they form the 'how to' for each step of the trial process, it's important to keep track of which version is which (usually dating the footer is a good idea and keeping a log of all your SOPs and which one is the latest of each version).

    The team working on your trial should read the relevant SOPs (whichever ones are relevant to thier work) and sign to say that they have read them. Through doing this, you can for example make sure that all your research nurses take consent in the same way - thereby standardising your methods.

    I am sure that many of our readers would be happy to share their exampls, but there are also lots of examples on the website already.

    here is an overall discusson about SOPs with lots of useful references: http://globalhealthtrials.tghn.org/community/groups/group/process_map/topics/40/

    There are some downloadable SOP templates on the right hand side of the screen here, including one for monitoring, one generic one, one for CRF development, and one for how to develop SOPs: http://globalhealthtrials.tghn.org/articles/downloadable-templates-and-tools-clinical-research/

    here is a discussion about SOPs and their review:
    http://globalhealthtrials.tghn.org/blog/post/224/2010/09/review-of-sops/

    I hope this helps. I am sure other uses will also continue to share their experiences, so don't hesitate to ask if you have any further questions.