Finding study leads, sharing them among sites and avoiding the enrollment of duplicate patients

Finding study leads, sharing them among sites and avoiding the enrollment of duplicate patients

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  Finding Study Leads, SharingThem Among Sites and Avoiding the Enrollment of Duplicate Patients
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  Introduction Finding new studyleads is always a good thing, especially for new clinical research sites. In many cases, there can be multiple research sites in one area. When this occurs, a couple of problems might arise. First, sometimes sites share the contact information of project managers to other sites, and second, some patients can get enrolled in more than one site for the same study. Next, we’ll tell you if sharing study leads is something that can be done without consequences, and we’ll also elaborate on the topic of avoiding duplicate patients. Even though it sounds complicated, there are simple solutions that can help you deal with these two types of situations. 2
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  Where to FindStudy Leads? www.trialjoin.com 3 There are many different ways in which sites can find new study leads and potential sponsors. Increasing the study pipeline is one of the most important goals of every research site, especially new ones. Usually, the two most commonly used routes for finding new studies are: - Public Databases; - Pharma Websites; No matter where you’ve found your study lead, it’s important to choose wisely and carefully, and only bid for studies that are a good fit for your site. Like this, you’ll be able to perform at your best and conduct the study well.
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  Where to FindStudy Leads? www.trialjoin.com 4 Pharma Websites Public Databases ClinicalTrials.gov and CenterWatch.com. Sites like ClinicalTrials.gov are primarily used by patients who are trying to find recruiting studies but can also serve as great tools for research sites to find new studies. The second best way to find studies to conduct is from pharmaceutical websites. Many of these pharma sites will have a list of all of their current studies together with their phase and progress.
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  Are You Allowedto Share Study Leads With Other Sites? www.trialjoin.com 5 When multiple sites reside in the same area, or when a group of sites stays in good contact, sometimes it can happen that they share study leads with each other. A study lead is basically going to be the contact information of the project manager of that study. This can happen if, for example, one site has found a lead but they’re too busy or unable to bid for that study, so they will share this lead with another site. Now, many people wonder - Are there any regulatory problems with sharing study leads and contact information? The answer to this question is a bit more complex, so below we’ll explain why.
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  Are You Allowedto Share Study Leads With Other Sites? www.trialjoin.com 6 Regardless of the situation, if you didn’t do anything wrong that might upset the project manager, sharing his contact information as a study lead won’t put you in trouble. You don’t have to be afraid of not getting any future studies from that project manager. Aside from that, it’s extremely rare that one project manager is managing multiple studies that are conducted at the same time. Even though sharing study leads might not be such a big issue, there are other things that absolutely mustn’t be shared. Next, you’ll see which. Sharing a study lead with another site and giving them the contact information of the project manager of that study is not something that’s specifically forbidden. Furthermore, it’s actually expected to share this information in any business, as a part of the normal networking among colleagues in the same industry. If you think that a project manager might not want you to share their contact information, it’s enough to just send them an email and ask them if they’re okay with you doing this. In most cases, they will tell you that they don’t mind. However, if they explicitly ask you not to share their information with other sites, then don’t.
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  What Are YouNOT ALLOWED to Share? www.trialjoin.com 7 Even though sharing study leads and project managers’ information with other sites might not be so bad, there are some things that you should definitely not share without permission. A perfect example for this would be if you had shared a CDA (Confidential Disclosure Agreement) or a Feasibility Questionnaire, or even worse - a protocol synopsis! All of these things that a project manager sends you are meant to be specifically for your site and with strict confidence. So it goes without saying that you should definitely not share such documents with any other sites. Making the mistake of sharing some of these documents can even put you in a position to get sued! 04 Confidential Disclosure Agreement (CDA) 03 02 01 Feasibility Questionnaire Protocol Synopsis Protocol
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  What Are YouNOT ALLOWED to Share? www.trialjoin.com 8 CAN BE SHARED - Study Leads - Contact Information (unless explicitly requested otherwise) CANNOT BE SHARED - CDAs - Feasibility Questionnaires - Protocol Synopsis - Protocols
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  How to AvoidDuplicate Patients? www.trialjoin.com 9 Enrolling duplicate patients in a study can pose significant issues for data integrity, quality, and analysis. Even the smallest number of duplicate patients can be the reason for a trial failure. Because of this, sites have to figure out how to prevent this occurrence. If the study that you’re currently working on at your site is also being conducted at other sites, especially if these sites are in the same area, you face the risk of enrolling duplicate patients. As we all know, this can often happen with studies that compensate patients for participating, so many of them will try to enroll at multiple sites just for the money. Regardless of the reason, in such cases, you will need to check for duplicate patients. While there are many different ways to do this, including fingerprint systems which can be really expensive, the best way is always the simplest! In order to avoid enrolling duplicate patients, get the suspicious participants’ initials and date of birth. Next, call the sponsor, CRO, or the project manager, and ask them to check the initials and the date of birth in their system. Like this, they’ll quickly be able to see if the patient has already been enrolled in a trial elsewhere. This is by far the best, easiest, and cheapest way to check for duplicate patients. So, feel free to do this each time a patient looks suspicious.
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  www.trialjoin.com CONCLUSION Hopefully, we’ve managedto help you understand the best ways you can find study leads for your site. Next, we’ve given you an answer on one really common question that bothers many people involved in research - Whether or not it’s ok to share study leads among sites? And finally, we hape that we’ve managed to give you an idea on how to avoid the enrollment of duplicate patients in your study! 10