Site Perspective – What Sites Really Think of Your Study Processes

In a business niche as highly critical, closely scrutinised and heavily regulated as pharmacovigilance it remains a puzzle why clinical development organisations struggle so often with the “end of process task” of distributing Safety Reports*. These are commonly known as Suspected Unexpected Serious Adverse Reaction or SUSARs. Timely safety report distribution is important because of its part in improving patient safety but also due to the compelling regulatory obligation to distribute this material promptly.

A Pharmacovigilance Process Summary

  1. Site reports Serious Adverse Reaction (SAR) within 48 hours.
  2. Sponsor determines if SAR is unexpected or not.
  3. Sponsor reports SUSAR to relevant regulators within days (for EMA within 7 days and typically 15 days for the FDA).
  4. In parallel to step 3 the sponsor has a responsibility to promptly inform other sites once the matter is identified as a safety issue. While there is some scope for interpretation here, “promptly” is normally interpreted as meaning a number of days and not some longer period of time. Typically sponsors will aim to distribute safety reports within 15 days.

For reference here is how the FDA explain things – p16 of FDA Guidance Safety Reporting Requirements for INDs and BA/BE Studies.

The reality is that this end of process task sounds simple to define but it is in fact pretty complex and time critical. In addition – organisations are often so blindly addicted to using email that alternative, more dynamic and reliable means of information distribution are strangely alien and fantastical. But why not use distribution means that allow for active information distribution, with real-time dynamic readership information? In an age where audience behaviour is closely tracked, isn’t it time you knew who has read your latest Safety Report, and more crucially who has not?

The Site Perspective – What Sites Really Think of Your Study Processes session from our Take a New Perspective on Compliance webinar series provided insight on how to keep your study moving during the COVID-19 pandemic. We heard from Erin Silverman, Ph.D., CCC-SLP, CCRC Research Coordinator and Adjunct Assistant Professor, University of Florida; and Helena Rocha, MSc. Study Coordinator, Instituto Português de Oncologia do Porto, both experienced site coordinators about what sites really think of your study processes. We’ve included a recap of the Q&A section from this webinar session. We would like to thank these women for offering their expertise and hope their perspectives provide you with helpful information regarding your study Oversight.


CCRC Research Coordinator and Adjunct Assistant Professor

University of Florida


Study Coordinator

Instituto Português de Oncologia do Porto

Adam Wood: Do you have a view on the easiest way to receive and review safety information, for example, in the investigator brochure and SUSARs?

Erin Silverman: So when I first started here, I had a study that had lots of SUSARS and we would print out every single one, give them to the PI, have the PI sign them, and then file them in a binder. And within a month, I had five huge binders filled with these things. The process I like now is, we get the electronic notification, we’re able to download the report electronically, and then we actually keep a separate spreadsheet with the name of the report, the date, the summary. And then we use that for signature so our PI’s can go through and do that and that way we’re using one sheet of paper versus a ton. But I think that the more things can be done electronically, the better. I was talking to Adam the other day, I said, “I just bought a house and everything’s online now.” You don’t actually get handed a stack of papers, even after you sign up the mortgage, they email you everything. And I would really like to see study operations to take up that model as well. It would spare the research coordinators, having to lug around binders all day. And I think it’s also going to increase accuracy and accountability in the end.

Adam Wood: Helena, how about you?

Helena Rocha: Completely agree. Electronic all the way. What we do is the PI downloads the documents, so there’s an electronic archive, and it trains the rest of the team on the information from that SUSAR in the weekly meeting that they have.

Adam Wood: Picking up Erin’s point about real estate transactions. So much is online now. I liken it to the fact that 20 years ago, banking was not online. And at the same time, I was involved in clinical research and advocating for electronic data capture. And people were like, “Ah, paper, you’ve got to stick with paper.” That’s what studies were like. And sure enough, all that banking is now online, you can barely operate in a Western economy without an online bank account. So finance could do it and those signatures that you refer to in the buying transaction, why can’t we do that in clinical research?

Erin Silverman: If you have a study that’s going to run over the course of years, you’re going to have investigators come and go. You’re going to have study coordinators come and go. Nurses come and go. Rather than that laborious process of re-doing the delegation log, which everybody hates, have an electronic one that can be electronically signed by multiple parties, just like a mortgage application and go from there. Easily updated. People’s roles can be easily terminated or initiated right there. So many issues seem to go around the delegation log and it just seems like it would be an easy fix.

Adam Wood: Next question is a point from Mary. “So I worked for a sponsor and I’ve been pushing to have several study coordinators review draft protocols to determine if the schedule of assessments makes operational sense from their point of view. How do you feel about that sort of contact with sponsors? Is that something you’d like, or would just prefer to deal with the CRO?”

Helena Rocha: I’m fine with either. I like the contact with the sponsor. I think they usually have a better understanding of the objectives that they have with the study. So I’m fine with contacting the sponsor directly.

Erin Silverman: I think it’s a great idea. A lot of sponsors will have advisory committees now that they’re inviting some study coordinators, study nurses, to participate in. And I think a lot of the object of those meetings is to do exactly this. Get a site level perspective on, “Is there a need for this? Could this be done? What’s a better way to do this?” And, they’re hopefully reaping some benefits from that. I’ve seen that more and more in the last two years.

Adam Wood: A question now from Wendy, with regards to patient recruitment. “What’s the best way for the sponsor and CRO to help with recruitment materials and/or outreach campaigns?”

Erin Silverman: We get a lot of that and some sponsors really go crazy with things like the straws and pins and koozies and things like that. And truthfully for our site, all of our recruitment goes through our clinics. We really don’t advertise or need to do any of that. So that might be an example where those monies and that effort could be better spent on other sites that do that kind of advertising, and listening to a site. And when I say we will do a hundred percent of our recruiting through our clinics, then we can kind of dispense with all of the tote bags and stuff like that that really won’t be used except by my kids when I take them home.

Adam Wood: Helena, do you have any experience at your site with patient recruitment campaigns?

Helena Rocha: In our case, all our recruitment goes through the clinics so the same in Erin’s case. We have the studies that we have with open recruitment on the hospital’s website. And we sometimes have referrals from other hospitals, from doctors that know about the study through the internet, through the website, and they think they have a patient that study would be the best option for and they refer the patient to us. The only publicity material that we ever used was the referral letters sent to the hospitals in the North of Portugal. But we have a very big sample of patients. We have, just in breast cancer, about 1200 new cases a year in our hospital. So we have a lot of patients to choose from for the study.

Erin Silverman: I do think the handouts that you can give in clinics are useful. So things that if someone’s being introduced to a study you can kind of give them to quickly take home. The other thing I’ve provided was useful were approved email templates, because a lot of times they’ll say, “Oh, this patient is interested. Can you follow up with them by email?” And just to have something that I could easily cut and paste and kind of personalize versus having to delve into the protocol, break it down, describe it, and simply to provide the information that they would want over email. So something like that could be very useful too.

Adam Wood: That’s a good point. What are your thoughts about virtual investigator meetings versus face-to-face? Currently we’re forced into virtual. Should we stick with virtual? Or return to face-to-face?

Helena Rocha: So, in our current situation it is necessary, but I think from the point we made earlier that the investigator meeting is important to us, at least the study coordinators, of interacting with other sites and sharing experiences. That’s possible in physical investigator meetings. So I personally prefer that tool to the online ones. Currently it’s not possible.

Erin Silverman: I think there are certain things that can’t be replaced by in-person meetings. A lot of times at the in-person meetings, you’ll get hands-on experience with a piece of equipment or a study device or something like that. The sidebar conversations that you have usually end up being pretty memorable and influential to the study. I think it’s just nice to have the social aspect of it too, and get to know your monitor. Get to know the people you’re going to be contacting during the study. Those relationships are really important. I had a study I just finished and thanks to a relationship I developed with the medical monitor we were able to get compassionate use of the drug for my patient after the study ended. And that wasn’t something that was ever going to go through official channels. So I think they should be resumed when we’re able to do it safely, but like we said earlier, just sort of prioritizing what really needs to be done. Certain things you can do quickly and dirty, “Here’s the slideshow, sign off on it, the GCP;” that kind of stuff. But other things  you need more time with, I think those are good. And I also think repeating an investigator meeting at the beginning, but then have one a year in which we can talk about things we’ve learned, but then also some of the sites that came on later can have those same benefits that the early sites had. So I think those are good ideas.

Adam Wood: We had other questions but we can’t get to them. Thanks to the audience. Great to have you on board and I hope you found it very useful listening to Erin and Helena.

Watch the full webinar at Site Perspective – What Sites Really Think of Your Study Processes

By Adam Wood, VP, Business Development at myClin

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