ClinOps Perspective: So, Oversight When You Can’t Visit Sites, eh?

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?

In the ClinOps Perspective: So, Oversight When You Can’t Visit Sites, eh? session from the Take a New Perspective on Compliance series, our attendees learned how to still fulfill common GCP obligations during a global pandemic.  We listened as Colleen Pellegrini, Consultant, Clinical Operations; and Jennifer Grove, Clinical Operations Consultant, County Manager for UK Cardiology Study shared tips from the field on how to bring GCP obligations under control and why generating evidence of Oversight shouldn’t break you. Below is a recap from the Q&A portion of the webinar with Colleen and Jennifer. It was a privilege to hear from these women and we hope their insight helps you better monitor your study with an inspection in mind.


Clinical Operations Consultant

County Manager for UK Cardiology Study


Senior Clinical Operation Consultant

Clinical Leader for Rare Genetic Disease Study

Adam Wood: Did any operational adaptations COVID require new IRB review and informed consent changes?

Jennifer Grove: Some of them did so but the MHRA allowed some changes to be made without amendments, but some did require amendment and we did have to do consent remotely.

Colleen Pellegrini: We actually pivoted first to remote visits for patients right away, prior to the amendment being finalized. And this is was in concert with the FDA guidance on clinical trials during the pandemic. Because we’re removing an immediate hazard to patients by not making them travel to a site. So we switched right away to a telemedicine platform in order to conduct study visits. And then, the amendments followed, which included an ICF addendum which was provided to the patients. Patients did not have to sign it though, because it was considered additional information about this study.

Adam Wood: You touched on a good point about your telehealth solution. It was a Zoom solution, but it wasn’t Zoom that we’re all used to. It was a dedicated platform, could you reflect on that for a few moments?

Colleen Pellegrini: So one of the options that Zoom offers is something called Zoom Telehealth. There’s a ton of information on their website about how they are HIPAA compliant. They meet all of the privacy requirements necessary for doctors and patients to speak virtually with a video conference. Doctors pivoted very quickly to using telehealth platforms. And I know that Zoom Telehealth is one that clinicians use in addition to researchers.

Adam Wood: Do you see that authorities may roll back any initiatives around remote monitoring that came in during the pandemic? Or is this really a new way for the future? I guess the way I’ll broaden that question is will sponsors revert to type? Will CRO’s?

Jennifer Grove: Risk-based monitoring is allowed within our regulations. It’s just that the sponsors and study sites have decided not to go that route. And surely we’ve now shown that this is the way to go now. And in regards to remote monitoring we do have the ability to do that. We have the systems that could allow us to do that. We had ethics approval. So the committees who are reviewing our studies are willing to allow us to do that. And I think now that we’re doing COVID-19 studies, I’m hoping that the hospitals that also go to consider allowing remote monitoring; I hope we push forward.

Adam Wood: In my experience, with multiple customers and multiple conference discussions about this, including presentations from regulators, they absolutely prefer studies to be run with risk-based monitoring. And therefore they’re supportive of remote monitoring within appropriate processes. I recognize there’s a distinction between remote SDV and risk-based monitoring, but the regulators absolutely are favorable towards risk-based monitoring. I’ve never heard anyone speak against it because it’s scientifically more robust, basically, a hundred percent SDV is a bit of a comfort blanket.

Jennifer Grove: You’re concentrating your efforts and your work into the area of your data that matters most. I spent time on sites asking research nurses to do pointless activities that I know will have no impact on my database whatsoever, but because I’ve been told 100% SDV, that is what I shall do. But I would rather be asking them about something more meaningful that will actually have an impact. And then everyone’s more engaged in the work as well, because they know what you’re asking them to do is actually going to have an impact on that data set.

Adam Wood: There is a quick question I can answer about the uploading of source documents and that sort of thing. And it was specifically, is it myClin handling this? In the cases that Jen and Coleen are referring to, no, it wasn’t. But myClin is also being used by other customers to do exactly that for various reasons. Now, what would be your suggestions now to colleagues are starting this autumn with the pandemic still raging, almost as bad as ever. I mean, certainly globally worse than ever, but in many of our countries, still highly challenging, if not quite worrying. So your recommendations for studies starting now?

Jennifer Grove: What we’ve been discussing is to try and find those vendors that can help you create a study team. So instead of 12 different companies, you’re working as one, in one place. myClin would help with that. But there are vendors that will do electronic consents that have the eCRF and as we’ve said have the ability to upload to the source. Telehealth. We were looking at companies that were going to do remote visits to the patients and send out nurses to the patients. And actually the study teams could do that. If your contract allows for that and you pay for it. It’s just, as you said, being flexible, thinking outside the box, if you want to do it a certain way, identify the vendor that helps you do that. Or talk to the vendors that you do have and they may have other links to other companies that they’ve worked with before we could help you.

Colleen Pellegrini: I agree with Jen. In addition, we’re starting the extension study very shortly. Prior to the pandemic our leadership made the decision that it would be a virtual/remote trial, meaning eConsent,  eSource or direct data entry, if you will. I’m sure there’ll be some paper source. But minimal, right. We live in a physical world, so there’ll be paper documents. But the majority of the trial will be conducted through virtual visits. Quarterly with sites, for example. And we are relying heavily on technology in order to make it happen. But like I said earlier, we rely on technology to make everything happen in the 21st century. Right? This is the one area where it’s, “Oh, are we really going to use an electronic system for this?” And myClin will definitely be a big partner for us moving forward.

Adam Wood: Brilliant. Thank you very much to Colleen and Jen, it’s been a fantastic conversation.

Watch the full webinar at ClinOps Perspective: So, Oversight When You Can’t Visit Sites, eh?

By Adam Wood, VP, Business Development at myClin

About myClin: Are you really ready for an inspection? Start using the myClin platform to take control of intricate and error-prone study documentation. Keep essential information at your fingertips to stay audit-ready at all times. Get started with more free resources and a demo at

About Clinical Works: Are you ready to move faster and smarter with a high impact, curated ClinOps team? We help new bio-pharm ventures and start-ups bridge the gap from investment to clinical development. Find out more at