groups » Trial Management » Monitoring guidelines

Hi Dears,

this topics is probably linked to the GCP discussion which is ongoing in the group on Trial Management. However.... in non-commercial, externally-funded research, monitoring can have a significant impact on the budget, and we must use it in a real cos-effective way.

An European Guideline says that non-commercial sponsors can skip the pre-study visit, if they have sufficient previous knowledge of the site. In our experience, however, the pre-study visit should not be skipped, because each study may require different skills, tools etc, and this should be evaluated well in advance.
On the other side, if pre-study visit has been well conducted, including specific training to the site staffs, the added value of the study initiation visit is often quite negligible.
Therefore, we are considering to adapt our procedures in this sense: do an in-depth pre-study visit, skip if appropriate the study initiation visit, and schedule the first visit after recruitment of few patients, so as to identify potential problems asap.

I would be interested in hearing your point of view on this. Thanks!

Raffaella

Reply

  • prayoon Prayoon Yuentrakul June 17, 2010

    Hi,

    I agree to your suggested approach. For some studies, depending on how they are being managed before the start of the study, study initiation may not be necessary provided that the study staff have received adequate training and ready for the start of the study. On the other hand, study initiaion may be necessary for a multicenter study to ensure consistency among study sites or when study start is delayed and there is a considerable lapse of time from pre-study visit which emphasis on study procedures is necessary. I also would take into consideration the complexity of the study wheather an initiation visit is needed before a greenlight is given to the site to begin accrual to avoid possible misunderstanding and mis-interpreation of the protocol and etc. When we develop our SOP on study initiation, we make a distinction between simple or complex studies. For a simple study, we use a check list of items/tasks that we need to ensure they are in place before the start starts and most of these can be done by the study staff themselves. So, inconclusion, I would adopt two approaches based on different factors described above and there should not be one way of doing this.

  • DavelineNyakundi Daveline Nyakundi June 17, 2010

    Hi,
    It indeed depends on the complexity of the trial/study. In my opinion, the preliminary preparations that are in-depth and objective play a pivotal role in success of a study. Thus I consider a pre-study visit critical in that it is during this time the site is assesses as to whether it is adequate in all measure to run the study efficiently with compliance to the protocol, SOPs, GCP and other regulations.
    Recently we conducted a pre study visit at my site for a study evaluating vaccine effectiveness. After this visit, we did not have study initiation visit and now plan to conduct an initial routine visit after a month of enrollment and participation in the study.
    The guidance the site gets as pertains to the study in question is key. Training of site team is very important. If the team is trained in all aspects of the protocol and GCP, this will go a long way in enhancing superior conduct of the study.

  • gogetii Gilbert Ogetii June 17, 2010

    Hi all, Thanks for the interesting discussion.

    I too think that having a detailed pre-study visit may preclude the need for a site initiation visit especially in trials with limited resources for monitoring and the sponsor has had longstanding engagement with the trial site. In this case it will be sensible to conduct both pre-study visit and SIV activities in a single visit as long as this will have the site adequately prepared to conduct the trial. Our site has previously conducted trials sponsored by GSK and a recent GSK sponsored study just needed an SIV and we were ready to go!

    I think a pragmatic approach to the above issue as you guys have discussed meets the minimum requirements for GCP guidelines.

  • tlang Trudie Lang June 17, 2010

    Well thanks all what an excellent discussion. Can I make a suggestion? With good and important exchanges like this we can expand them and invite others to contribute until we reach a consensus and then we can turn the discussion into an article that can be reviewed by peers and placed in the guidance article section. Those who have contributed to the discussion will be authors of the article. So if anyone reading this has a point to add then please do so and please also pass this link to anyone else you know might have a helpful view on this topic. We can then generate a guidance article that summarises all the points and is accompanied by any templates you all use or example document, or even training slides that we can place with the article. Do send your views on this. thanks again

  • rravinetto Raffaella Ravinetto June 17, 2010

    Hi Trudie, I welcome your suggestion. The added value of this website can be, in addition to exchanging views about people who share the same concerns and problems, to be able to communicate to the outside world, from a North-South prospective. While building on real life experience!

  • Promero Palma Romero July 13, 2010

    Yes I agree with much of the discussion. In our studies we work to ICH-GCP and we plan our monitoring relative to the risk and nature of the study. However when we have outside sponsors working with us there seems to be a different approach. Here we often have CRO come and monitor our sites. Whilst they are always very nice and helpful they do not often have a good understanding of the disease or the protocol and spend most of their time checking administrative things and that the CRF's are complete. They also come very often. This must be expensive for the sponsors and it takes up so much of our time and they just seem to check the same things. They do not seem to account for the type of study or think too much about what the endpoints are. It would be better to have a more tailored approach that helps us more with the practical and clinical aspects of running the trial well.

  • rravinetto Raffaella Ravinetto July 13, 2010

    You're absolutely right. We should be able to maximize the usefulness of a monitoring visit, by doing it in a kind of reasoned way, tailored to the kind of diseases, the kind of health facility, the kind of context etc.

    At the end of the day, monitoring visits are not an objective in itself, but rather an important tool that contributes to fulfill the real objectives: maximize the quality of the data and the protection of study subjects.

  • jagarwal jagarwal May 10, 2011

    In our site we monitor our own studies.Is this OK or should we use a CRO? Are there any requirements?

  • gogetii Gilbert Ogetii May 10, 2011

    Hi Jagarwal,

    I think monitoring your studies is very much in order. According to GCP guidelines monitoring can be done by appropriately qualified and trained persons wand these can be persons working in your institution. In fact this could have several benefits in that it can be cheaper, monitors and study staff get to interact longer thus creating an environment for mentoring rather than "policing"

    In our institution we have an in-house monitoring scheme. Our scheme wholly monitors academic trials not monitored by CROs and also augments those monitored by CROs. This not only improved the quality of trial conduct but also added a dimension to people responsibilities.

    Nonetheless there is always a need to ensure internal monitoring is conducted to high standards and this could be achieved through regular refresher training and joining a network of clinical trial sites running similar schemes.

    My 50 cents!

    Gilbert

  • gogetii Gilbert Ogetii May 11, 2011

    Hi,

    Check out this paper which discusses how its being done in our setting...

    http://www.webmedcentral.com/wmcpdf/Article_WMC00891.pdf

    Gilbert

  • mtumba mary mtumba May 24, 2011

    This is a great paper and I think it will encourage others. We need to find ways to monitor our studies that are logical and make sure the trials run properly. The example you give is one we shall try

  • skmm1999 mohammed mansour Sept. 18, 2013

    Hi every one, I'm sorry I will take you slightly away from the subject of your discussion I just wanted to take your opinion on how to deal with protocol violations and deviations and what is the practical action that we supposed to do with each violation, for example enrolling patient without consenting is considered as a serious breach to the protocol, in real world do we really close the site in case it was repeated, also enrolling patient which slightly outside the lab range as indicated in the protocol the thing that happens very frequently do we really have to exclude those patients from the study

  • rravinetto Raffaella Ravinetto Sept. 19, 2013

    Dear Mohammed, in general I would say that any deviation must be adequately documented, corrected if possible, and the correction must be documented as well.
    The way and timelines you deal with specific protocol deviations will depend on the kind of deviation, and on its impact on the patient's autonomy and safety, and on the study results.
    For exemple, if a site makes a mistake in documenting the consent, the mistake must be documented; but if the site systematically recruits patients without consent, it should be closed. Deviation in inclusion criteria will be documented in the database and dealt with in the statistical plan, but if such a mistake puts the patient at risk of harm, than the patient should also immediately stop the study drug and be followed up by the study team, to ensure that no harm appears and that any side effects are managed by the study team.
    Raffaella

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