Standard Operating Procedures (SOPs) are key tools that offer guidance in the execution of various activities in research and other spectra. For these documents to be relevant and robust on the intended purpose they have to be well written by the users and their appropriateness monitored periodically. Besides this being open-in that review can be done as need arises, normally various owners have decided to review them annually or biennially and offer retraining to their staff for those activities that run for over a year. Could someone comment whether this is universally recommended (that there need to be defined intervals within which the SOPs can be reviewed.) or can be left open (no timelines specified). Is there a guideline that gives guidance on the same that you know of? will be glad to get your take on this!

Reply

  • Hi Daveline,

    I am not sure about any official recommandations on how often the SOPs should be reviewed. The WHO GCP do not give any recommendations in this sense.

    At our unit, we have agreed that SOPs should be revised at least every three years, to check if they need updating based on practical experience.

    In some cases, no changes were needed at the three-year revision, while in other case some changes have been implemented (for instance, we have recently modified the one on SDV, to better explain when and why the minimal percentage of SDV should be increased).

    The challenge is also to ensure that the SOPs remain useful tools, which help the study staff in their daily activities, and they do not become an objective in itself!

    Raffaella

  • phaikyeongcheah Phaik Yeong Cheah 22 Sep 2010

    Hello! I would vote for a review every 2 years. We have tried yearly reviews, and it seems a bit short.

  • ausdarose AYOOSU ROSE 8 Oct 2018

    My own view on the sops review, is annually, this is because standard procedures are released too often, with different school of thought.

  • urbanclapae urbanclap 18 Oct 2018

    Nice post. This being open-in that review can be done as need arises, normally various owners have decided to review them annually or biennially and offer retraining to their staff.
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