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Friday, February 3, 2012

Lead CRA Q&A: Do We Have To Do an SIV?

Melissa commented in... "Pre-Study Visits and Site Initiation Visits":
Do sites HAVE to have an SIV? Especially for a simple data collection study? Or is a web training sufficient for sites that have done research with us before?  -September 9, 2011

NadiaBoBadia responds...

Hi Melissa, it sounds like you may be working on a non-interventional observational study (so no medication or any special assessments or survey instruments are given. For your study, perhaps you are just reviewing standard data that would be collected in the course of normal clinical conduct). In that instance, you may be able to do a web training for sites that you know and have worked with recently.

Without an in-person visit, however, how will you be sure that the facility remains adequate and that the study can be conducted there feasibly? As sponsors, we are obligated to ensure that the people working on our studies are qualified by education and experience. You could do that remotely by reviewing CVs and monitor reports for other studies. I hope this addresses your question. certainly there is a trend to not have expensive Investigator Meetings and I have worked on many studies where the PSV is combined with an SIV.
 It is important to visit a clinical study
site to inspect the labs, pharmacies,
facilities, storage, and other areas
where the research will be conducted
to ensure they are adequate.

It is more rare for me though to work on a study where there is no SIV at all but this sometimes happens when it is a site that we have had recent experience with (say in the past year).  We sometimes also waive the SIV when the PI and the important study staff attend the IM. If you won't be performing SIVs, definitely document at the sponsor level TMF how you determined the sites were qualified and trained.

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Thursday, February 2, 2012

ACRP 2012 Global Conference in Houston, TX

I received a mailer the other day with program details for the ACRP 2012 Global Conference.  I am on the ACRP mailing list but I have never attended the conference before.  This year it is being held in TX April 14-17.  There are a handful of sessions I would be interested in and I think the networking and vendor showcase could be worthwhile.  The conference has content for monitors and program managers but also content geared towards study coordinators and site directors.

Here is a link for more information on the conference if any of you are interested in attending:

Who is heading to Texas for ACRP Global
Conference in April?  Blackberry and Brisket...
who could ask for anything more!
If you have been to the conference before I'd love to hear if it was fun and useful.  You can leave a comment here or shoot me an email at