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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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Anonymous said...

I am having difficult to deal with a demanding CRA that monitoring our site. She always send a few email to request a few tasks to be done on the same day and demand to complete by the end of the day. I feel bully...How do i deal with this situation? I don't want to make a drama because of this because i am new in this job. Me and my colleague have spoken to her to consider giving us appropriate deadline but she has remain the same.

Anonymous said...

I'm enjoying this blog very much. Please keep it up.

Pre-accrual training is a really sore spot for me.

First, substituting the IM for on-site SIV is done at the Sponsor's peril. In most of my experience the IM generally is a joke, from a quality of participation standpoint.

Why? Most commonly, the closer the meeting is to warm sunshine and/or a large body of water, the less attention you get from the participants. Also, a certain percentage of PIs can be counted on to bring along a spouse, instead of the study coordinator who will actually do all the work. These sites almost invariably stink out the joint, once the study starts.

Also, how many studies have you worked on where accrual starts as soon as everyone gets home from the IM? Riiiight. Few if any. What happens when there is a delay of one, two, three months?

(Geez, why do drugs cost so much money?!?!?)

In conclusion, the IM is an extremely expensive way to impart information that will more likely than not be forgotten before it is needed. It's a relic from a bygone era when clinical research was "easier," and there was more of an anything-goes mentality toward schmoozing.

When I started as a CRA 20 years ago, IMs were seen by many site staff as a perk. Today, I'm hard pressed to find anyone who sees them as anything but a chore (that often requires an uncompensated weekend away from home, depending on where you work)

That is not to say the on-site SIV is much better. I know within five minutes who is invested in my SIV, and who will "yeah right" me to death, only to get Every Single Thing wrong once the study starts. The former is great, the latter is a big fat waste of everyone's time.

But we have to cover our asses, so we get on the plane...

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