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Finding Study Leads,
Sharing Them Among Sites and Avoiding
the Enrollment of Duplicate Patients
Introduction
Finding new study leads 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
Where to Find Study 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.
Where to Find Study 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.
Are You Allowed to 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.
Are You Allowed to 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.
What Are You NOT 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
What Are You NOT 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
How to Avoid Duplicate 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.
www.trialjoin.com
CONCLUSION
Hopefully, we’ve managed to 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

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

  • 1. Finding Study Leads, Sharing Them Among Sites and Avoiding the Enrollment of Duplicate Patients
  • 2. Introduction Finding new study leads 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
  • 3. Where to Find Study 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.
  • 4. Where to Find Study 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.
  • 5. Are You Allowed to 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.
  • 6. Are You Allowed to 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.
  • 7. What Are You NOT 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
  • 8. What Are You NOT 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
  • 9. How to Avoid Duplicate 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.
  • 10. www.trialjoin.com CONCLUSION Hopefully, we’ve managed to 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