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Most Common Clinical Research Site
Worries and Complaints
Introduction
All clinical research sites, especially new ones who’ve just entered the business,
have a couple of common worries and complaints. The clinical research field is
complicated and there are tons of formalities, papers, vendors, rules, regulations,
etc. Taking into consideration the sensitivity of this business, the fact that human
participants are involved, as well as the large amount of money that sponsors
spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection
visit, negotiations, then routine monitoring visits, subject enrollment and
randomization, etc. All of these steps are equally important in order to conduct a
successful trial. However, the complexity of the clinical research process usually
worries and confuses new research sites. We’ve done a research on some of the
most common site worries and complaints throughout the duration of a trial.
Below, we’ll give you answers to all your questions.
2
3
Complaint #1: Budget Negotiations
This one is the most common complaint among sites, especially new ones – how to
estimate if the offered budget is fair and enough for the trial? In this case, the best
thing you can do is calculate every test, procedure, overhead, salaries, and all other
fees.
In order to do this better, you can check the Schedule of Assessments in the protocol
and see if every visit and procedure is covered. In most cases, the sponsor will start the
negotiation process by offering a low budget which usually won’t be enough to cover all
fees. For this reason, you’ll have to learn how to negotiate. Next, we’ll give you some
negotiation tips that will help you achieve a win-win situation.
PAGE 4
© 2016 Planner-Template All rights reserved
Complaint #1: Budget Negotiations
Carefully go through all
aspects of the agreement
Be armed with
documentation
Many negotiators make the mistake to focus
only on what they think is most important –
the budget – and they forget to pay attention
to other, equally important parts of the clinical
trial agreement. Knowing all the details of the
agreement can give you more leverage and
power to negotiate further. For example, if
you see that there are some complicated
procedures that your site will need to perform,
you can use this fact as a leverage for the
sponsor increasing your budget.
This is another tip that we mentioned before
and it's one that is really important in clinical
trial agreements. Negotiation can be a long
process and more than just 2 people are
always involved. In order to avoid any
conflicts in the future, it's really important to
document and have records of the whole
negotiation process. This means absolutely
everything – phone calls, e-mails, offers and
counter-offers, any type of correspondence,
who spoke with whom, etc.
PAGE 5
© 2016 Planner-Template All rights reserved
Complaint #1: Budget Negotiations
Make a higher first
offer
Always have a
backup plan
Making a higher than expected
first offer will give more space for
negotiating and will ensure that
even if the sponsor goes down
with the counter-offer – it's still
going to be acceptable for your
needs and you won't work at a
loss.
Anticipating what the client will do is
important in order to have a backup
plan. Having a counter-offer means
finding alternatives in order to satisfy
both parties until an agreement is
reached. If you see that the sponsor
cannot give what you're asking for in
one area, then trade this for
something else you might need.
'Manipulate' with the offer until both
you and the sponsor are satisfied.
Rights to negotiate
in the final offer
When you and your sponsor finally
reach an agreement, be sure that
you include your right to renegotiate
in case if something changes.
Sometimes when a site is
conducting a trial, some
unpredictable things arise. You need
to have this right to renegotiate
included in the final offer and
agreement in order to protect your
site during the trial period.
6
Complaint #2: Acquiring Certifications
and Credentials
Conducting a clinical trial entails dealing with various different systems such as the EDC
system, IVRF or IWRF. These programs usually require trainings that can be long and
difficult.
Another problem in this area is that you’ll have to choose who needs to be certified and
who needs to have credentials to sign official emails, documents, etc. All of these things
can be confusing for the new site. However, they need to be done in order to work
according to all standards and regulations.
But, not to worry!
PAGE 7
© 2016 Planner-Template All rights reserved
Complaint #2: Acquiring Certifications and Credentials
Even though programs such as IVRF,
IWRF, or EDC might seem ridiculous at the
beginning, such programs and systems
will automate many tasks and eventually
make your job much easier throughout
the whole study!
Your site PI will usually need to
have an EDC certification
because he/she is responsible
for signing off on EDC files.
Next, few people of your
choosing will need to have IVRF
or IWRF access to be able to
randomize study participants.
And finally, different people will
need to have different
passwords and login details of
different things.
8
Complaint #3: Recruitment of
Subjects
It’s no wonder that recruitment is the biggest and most common problem in clinical trials.
It’s estimated that approximately 11% of sites fail to enroll a single participant! And the rest
of the sites are usually under-enrolling.
The big question is WHY?
There are many recruitment strategies out there, and here we’ll try to give you some of the
best ones in order to help you find patients more easily:
PAGE 9
© 2016 Planner-Template All rights reserved
Complaint #3: Recruitment of Subjects
Measure Everything
Optimize your Website
Approach Local GroupsUtilize the Database
Use your searchable patient
database from your CTMS to
locate ideal patients based on
specific criteria, and narrow
down the patients that you can
contact through email or a call.
Approaching local associations
and communities can be great
recruitment tools.
Keep measurements on which
marketing campaigns are
working and find out if a
certain specific campaign
helped you to actually
randomize patients or only
added new names.
Create an area on your website
that allows patients to see
which clinical trials are ongoing
at the moment. Add a blog and
news page to your website.
PAGE 10
© 2016 Planner-Template All rights reserved
Complaint #3: Recruitment of Subjects
Support CharitiesFollow-Up
Offer Screenings
Educate
Patients often are unfamiliar
with clinical research and
medical jargon. Helping them
by explaining diagnoses,
medical procedures and clinical
trials in a simplified and friendly
way will help them feel more
active and autonomous in their
decision.
When you know the needs of
your patients, you can start
offering services that will help
them. The most common
things are screenings for blood
pressure, memory, hearing,
diabetes, etc.
Giving to local charities and events will help
you become active in supporting medical
causes and it’ll help increase the chances to
interact with potential patients.
Even after initial contact, follow up and
follow through. Send them study
information, and during every call
make a reason to follow-up.
Quick Responses
Respond quickly to inquiries
because they are at the highest
level of interest at this point.
The more quickly you respond,
the more likely you are to
connect when with them.
11
Complaint #4: Routine Monitoring Visits
While Routine (or Interim) Monitoring Visits are usually not a problem themselves, keeping up
with them and solving all the action items from the previous visit can sometimes be a problem.
During a routine visit, the monitor or the CRA will check various things at your site and then
give you a list of action items to be changed or resolved until the next visit. This is where many
sites fail to follow through.
These visits usually occur anywhere from 6 to 8 weeks, depending on how busy the site is, and
the best way to keep up and not fall behind is to do all your tasks regularly and on time. Like
this, you won’t have a bunch of tasks all gathered to be finished in 2 days.
12
Complaint #5:
Blinded vs Unblinded Trials
Depending on the type of study you’re conducting, some people will be allowed to know/do
some things, and others won’t. Additionally, a study protocol usually requires more than ten
different vendors to be conducted! Furthermore, some people at the site will have certifications
and credentials for some programs and systems, while others will have the same for other
programs.
All of the above things show us how complicated a trial can be. Not everyone from the staff is
supposed to know everything. All of this will be explained to you in the protocol. Once you’re
aware of the situation, choose which people are allowed to have permission and details for
which things, and keep the rest to a need-to-know basis. Like this, you’ll make sure that you
aren’t breaking any rules and that you’re conducting an ethical and unbiased study.
www.trialjoin.com
CONCLUSION
As a final note, make sure to always be proactive and curious about everything that’s going on at the site. If you’re a new site just
entering the clinical research business, follow our tips and get familiar with how things are done.
As we’ve said, some of the most common worries you’ll encounter belong in the areas of patient recruitment, budget negotiations,
certifications and credentials training and permission, and monitoring visits.
All of these issues can be solved by proactive and regular working, completing tasks on time, proper documentation, and enough
training.
13

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Most Common Clinical Research Site Worries and Complaints

  • 1. Most Common Clinical Research Site Worries and Complaints
  • 2. Introduction All clinical research sites, especially new ones who’ve just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible. There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. We’ve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, we’ll give you answers to all your questions. 2
  • 3. 3 Complaint #1: Budget Negotiations This one is the most common complaint among sites, especially new ones – how to estimate if the offered budget is fair and enough for the trial? In this case, the best thing you can do is calculate every test, procedure, overhead, salaries, and all other fees. In order to do this better, you can check the Schedule of Assessments in the protocol and see if every visit and procedure is covered. In most cases, the sponsor will start the negotiation process by offering a low budget which usually won’t be enough to cover all fees. For this reason, you’ll have to learn how to negotiate. Next, we’ll give you some negotiation tips that will help you achieve a win-win situation.
  • 4. PAGE 4 © 2016 Planner-Template All rights reserved Complaint #1: Budget Negotiations Carefully go through all aspects of the agreement Be armed with documentation Many negotiators make the mistake to focus only on what they think is most important – the budget – and they forget to pay attention to other, equally important parts of the clinical trial agreement. Knowing all the details of the agreement can give you more leverage and power to negotiate further. For example, if you see that there are some complicated procedures that your site will need to perform, you can use this fact as a leverage for the sponsor increasing your budget. This is another tip that we mentioned before and it's one that is really important in clinical trial agreements. Negotiation can be a long process and more than just 2 people are always involved. In order to avoid any conflicts in the future, it's really important to document and have records of the whole negotiation process. This means absolutely everything – phone calls, e-mails, offers and counter-offers, any type of correspondence, who spoke with whom, etc.
  • 5. PAGE 5 © 2016 Planner-Template All rights reserved Complaint #1: Budget Negotiations Make a higher first offer Always have a backup plan Making a higher than expected first offer will give more space for negotiating and will ensure that even if the sponsor goes down with the counter-offer – it's still going to be acceptable for your needs and you won't work at a loss. Anticipating what the client will do is important in order to have a backup plan. Having a counter-offer means finding alternatives in order to satisfy both parties until an agreement is reached. If you see that the sponsor cannot give what you're asking for in one area, then trade this for something else you might need. 'Manipulate' with the offer until both you and the sponsor are satisfied. Rights to negotiate in the final offer When you and your sponsor finally reach an agreement, be sure that you include your right to renegotiate in case if something changes. Sometimes when a site is conducting a trial, some unpredictable things arise. You need to have this right to renegotiate included in the final offer and agreement in order to protect your site during the trial period.
  • 6. 6 Complaint #2: Acquiring Certifications and Credentials Conducting a clinical trial entails dealing with various different systems such as the EDC system, IVRF or IWRF. These programs usually require trainings that can be long and difficult. Another problem in this area is that you’ll have to choose who needs to be certified and who needs to have credentials to sign official emails, documents, etc. All of these things can be confusing for the new site. However, they need to be done in order to work according to all standards and regulations. But, not to worry!
  • 7. PAGE 7 © 2016 Planner-Template All rights reserved Complaint #2: Acquiring Certifications and Credentials Even though programs such as IVRF, IWRF, or EDC might seem ridiculous at the beginning, such programs and systems will automate many tasks and eventually make your job much easier throughout the whole study! Your site PI will usually need to have an EDC certification because he/she is responsible for signing off on EDC files. Next, few people of your choosing will need to have IVRF or IWRF access to be able to randomize study participants. And finally, different people will need to have different passwords and login details of different things.
  • 8. 8 Complaint #3: Recruitment of Subjects It’s no wonder that recruitment is the biggest and most common problem in clinical trials. It’s estimated that approximately 11% of sites fail to enroll a single participant! And the rest of the sites are usually under-enrolling. The big question is WHY? There are many recruitment strategies out there, and here we’ll try to give you some of the best ones in order to help you find patients more easily:
  • 9. PAGE 9 © 2016 Planner-Template All rights reserved Complaint #3: Recruitment of Subjects Measure Everything Optimize your Website Approach Local GroupsUtilize the Database Use your searchable patient database from your CTMS to locate ideal patients based on specific criteria, and narrow down the patients that you can contact through email or a call. Approaching local associations and communities can be great recruitment tools. Keep measurements on which marketing campaigns are working and find out if a certain specific campaign helped you to actually randomize patients or only added new names. Create an area on your website that allows patients to see which clinical trials are ongoing at the moment. Add a blog and news page to your website.
  • 10. PAGE 10 © 2016 Planner-Template All rights reserved Complaint #3: Recruitment of Subjects Support CharitiesFollow-Up Offer Screenings Educate Patients often are unfamiliar with clinical research and medical jargon. Helping them by explaining diagnoses, medical procedures and clinical trials in a simplified and friendly way will help them feel more active and autonomous in their decision. When you know the needs of your patients, you can start offering services that will help them. The most common things are screenings for blood pressure, memory, hearing, diabetes, etc. Giving to local charities and events will help you become active in supporting medical causes and it’ll help increase the chances to interact with potential patients. Even after initial contact, follow up and follow through. Send them study information, and during every call make a reason to follow-up. Quick Responses Respond quickly to inquiries because they are at the highest level of interest at this point. The more quickly you respond, the more likely you are to connect when with them.
  • 11. 11 Complaint #4: Routine Monitoring Visits While Routine (or Interim) Monitoring Visits are usually not a problem themselves, keeping up with them and solving all the action items from the previous visit can sometimes be a problem. During a routine visit, the monitor or the CRA will check various things at your site and then give you a list of action items to be changed or resolved until the next visit. This is where many sites fail to follow through. These visits usually occur anywhere from 6 to 8 weeks, depending on how busy the site is, and the best way to keep up and not fall behind is to do all your tasks regularly and on time. Like this, you won’t have a bunch of tasks all gathered to be finished in 2 days.
  • 12. 12 Complaint #5: Blinded vs Unblinded Trials Depending on the type of study you’re conducting, some people will be allowed to know/do some things, and others won’t. Additionally, a study protocol usually requires more than ten different vendors to be conducted! Furthermore, some people at the site will have certifications and credentials for some programs and systems, while others will have the same for other programs. All of the above things show us how complicated a trial can be. Not everyone from the staff is supposed to know everything. All of this will be explained to you in the protocol. Once you’re aware of the situation, choose which people are allowed to have permission and details for which things, and keep the rest to a need-to-know basis. Like this, you’ll make sure that you aren’t breaking any rules and that you’re conducting an ethical and unbiased study.
  • 13. www.trialjoin.com CONCLUSION As a final note, make sure to always be proactive and curious about everything that’s going on at the site. If you’re a new site just entering the clinical research business, follow our tips and get familiar with how things are done. As we’ve said, some of the most common worries you’ll encounter belong in the areas of patient recruitment, budget negotiations, certifications and credentials training and permission, and monitoring visits. All of these issues can be solved by proactive and regular working, completing tasks on time, proper documentation, and enough training. 13