LOUISE: Welcome everyone to NLM Office Hours.
My name is Louise To.
I am a Technical Information Specialist from the Office of
Engagement and Training at the National Library of Medicine,
and I'm going to be your moderator for today's Office
Hour.
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Feel free to visit NNLM.gov to learn more.
So today for NLM Office Hours, we have Stacey Arnold from the
ClinicalTrials.gov PRS team, also known as the Protocol
Registration and Results System.
Stacey will give an overview of the modernization of the PRS,
the system used to submit clinical trial information that
is posted on clinicaltrials.gov. She will provide something like
a mini-tutorial on how to register a trial using the
modernized interface,
the PRS Beta. Assisting me in managing today's session is
Michael Tahmasian and Kate Majewski, also from the Office
of Engagement and Training
at NLM. You will have three ways to communicate with us during
today's session.
You can use the chat feature and we'll be watching for your
questions in the chat.
You may also raise your hand if you'd like to unmute and ask
questions verbally.
I will be looking for those hands. And you may also use the
feedback icons to give reactions throughout the session and
that's located on the bottom of your menu options in Zoom.
Also of note that we have a closed captioner with us today.
You can find the closed captioning button in your menu
options.
And now without further ado, let me pass this on to Stacey to
tell us about ClinicalTrials.gov PRS. STACEY: Thanks Louise.
I'm going to start sharing my screen now and hopefully it will
go seamlessly.
OK, hopefully everyone can see my screen, and let me actually
go back a sec.
OK. So thanks everyone.
As Louise mentioned, my name is Stacey Arnold.
I am a Protocol Registration and Results Database Subject Matter
expert with expertise and results and general system
functions.
I'll be describing our efforts to modernize the PRS and I'll
also demonstrate the current features of PRS Beta.
So to begin with, I'll give a brief overview of the progress
of the modernization effort so that we can spend the majority
of our time looking at the beta site.
Over the past few years, we've been working to modernize both
the ClinicalTrials.gov public site and the PRS database, as
Louise said, which is the database that is used to submit
records for publication to the public site.
In Year 1 of this process, we engaged stockholders to
determine needs and plan our approach to modernization of
both sites.
We enhanced our internal processes and developed road
maps.
And then in Year 2, we launched the first release of the
ClinicalTrials.gov Beta.
In Year 3, we launched the first release of PRS Beta and we've
been conducting usability research and making iterative
improvements since those first releases. As we continue
modernization
in Years 4 and 5, we made ClinicalTrials.gov the beta
primary and we'll continue to engage stockholders and make
refinements in response to feedback as we strive to make
the PRS Beta primary as well.
This is a view of the road map for PRS beta and the work that
remains to be completed.
You'll see that we've been working this year to complete
the protocol section and to allow for submission and QA/QC
review of registrations.
As we head into 2024, we'll be working on adding the results
and documents sections and the corresponding processes for
results submission and review.
Finally, we'll focus on supporting account management
from within PRS Beta.
In the next few slides, I'll describe how to access PRS Beta.
To access PRS Beta, users must first log into the classic site.
When they arrive at the record list, they will see a big, green
button that says New PRS Beta Homepage.
Clicking on this button will take users to the PRS Beta
record list and users can return to the classic site at any time
by clicking on the Back to Classic website link at the top
of the page.
You'll also see there's a Feedback button on this page and
you can use that from any page to provide us with feedback
about what you're experiencing as you play around with the beta
system.
When we talk about the classic PRS site, we are referring to
not only the live PRS which we have been calling the PRS
Production site, but also the PRS Test site.
Users can access PRS Beta from within either site, and for
those who haven't used the PRS test site, anyone can get an
account here.
Some of you may already have one if you had a PRS account before
2016 and it is a playground version of the PRS production
system where you can go to practice data entry before
submitting records in the live system.
So if you happen to have a PRS account before 2016 and you
didn't know you had a PRS test account, you use the same login
information that you had been using in 2016 or before.
So we've been utilizing the test system to ready PRS Beta for
release to the live PRS Production system.
Updates to PS Beta are first released in the PRS Test system
because this allows us to test in a stable environment and
detect and fix bugs before we deploy PRS Beta to the
production system.
Any users with a PRS Test account can provide feedback,
and the system supports both administrator and normal user
accounts.
Once updates are released to the PRS Production system, we
continue to collect feedback to fix any additional bugs that
haven't been detected previously and records that are created in
PRS Beta and updates that are made to existing records in PRS
Beta can be accessed in the Classic environment in either
the PRS Production or PRS Test System.
In the remainder of the presentation, I'll give
overviews of the various sections of PRS Beta that we've
so far, and I'll begin with the record list.
So this is a view of the top menu of PRS Beta as accessed
from the record list page.
This top menu is available on any of the pages within Beta. So
if you click on the Records menu, you can return from an
individual record to the record list at any time, and you can
also create a new record. From the About menu
you can access the About PRS Beta document, which describes
how to navigate the record list and provide some troubleshooting
tips, and you can also access the release notes for every PRS
Beta released so far.
Finally, if you click on your account details to the far
right, you can access your profile information, the list of
administrators for your organization, and you can also
log out of the system this way.
So all columns that are available at your level of user
access are now conveniently provided in a single location.
You can click on the Customize Columns tab to pull up a model
that lists all available columns.
You can check or uncheck the boxes to the left of each header
to add or remove columns from the view.
You can drag and drop columns to change their order or move them
with the up or down arrows.
And you can hover over information icons to learn more
about the type of data that each column provides.
Note that if there is a column of particular interest, we've
been getting questions about the problems column,
this model can be used to move that column to the top of the
list so that it is always present in the viewable frame.
So you can actually filter for information in the column that
way.
And I think that we are looking to also maybe create a button
that allows people to see their problem records in a more easy
way.
So you can see on this view that Feedback button as well.
So the reorganized column view can be named and saved by
clicking on the Saved Views column button, and this button
can also be used by administrators to select
standard selections of columns that include the Planning view
or the Public Site view.
The Export button can be used to export the current view or all
of the available columns, and each column can be sorted and
filtered, and links to the left of each listed record can be
used to open the record in either the classic system or in
the Beta system.
In addition, there are links within each row that can be used
to e-mail staff, and some rows also contain more information
about select columns, such as the FDAAA status or columns that
indicate when updates are expected.
So in summary, from the PRS Beta record list, users can now
reorder columns, access all available columns from a single
location, save views, filter data in all columns and not just
a select few, and send emails directly to staff members who
are responsible for each record.
So now we'll move on to the Protocol section.
If a user clicks on Create New Record in the Records menu, they
will see the following page with tips for creating a record that
are presented and easier to understand language.
Next to each data element name, users will see an information
icon.
Clicking on the icon will pull up drawer content that includes
a brief description of the data element and tabs that, when
expanded, provide additional information and the data element
definition.
Users can directly access the relevant data element definition
now for the data element of interest without having to
scroll through definitions for the entire module. And here
we're highlighting the secondary ID data element to show some
important improvements in data entry.
On-screen content has been added to emphasize the importance of
including information for relevant NIH funded grants
in this section. More than one type of secondary ID can be
selected for inclusion at one time, and more than one of each
type of secondary ID can be added on the same page. For
comparison,
in the classic system, the secondary ID button pulls up a
menu from which only one option can be selected at a time, and
the user must continue to click and select from this popup to
add as many secondary IDs as are needed.
Once a record is created, the user is directed to the protocol
summary and can use a side navigation panel to access the
remaining modules for inclusion of additional registration
information in any order.
At the top of the page is a notice that provides important
information about potential differences between PRS Beta and
the classic system, as well as the brief title, NCT number, and
unique protocol ID for the record currently being edited
for ease of reference.
Once all of the protocol information has been included,
the user can navigate to the Record Summary tab to proceed
with reviewing the record and submitting it for PRS QA/QC
review.
So in summary, enhancements to the Protocol section include
more immediate access to information about each data
element.
Essential information is provided on screen and
additional information is provided in a pull-out drawer
where individual components can be expanded or collapsed for
ease of reading and the relevant data element definition is
readily available.
The information that is provided is now easier to understand.
There's also improved navigation and information for each model
can be added in any order.
There are also fewer clicks required to provide relevant
details.
The site also has a modernized look and feel.
In the final slides, we'll take a look at the Record Summary
page.
At the top of each page within a record are a couple of menus
that allow users to contact staff and perform additional
record actions.
If you click on the People menu, you can find out information
about the record owner and the last updater, as well as update
the list of staff with access to the record.
If you click on the Record Access option, you will see that
you can now search for users and e-mail users directly from the
list.
If you click on the Actions menu, you can change upload
options and download, delete, or copy the record.
If you click on the Download Record option, you'll see that
multiple download options can be selected at once and that
content has been added to explain the purpose of each of
the download options.
The record summary page also includes dates and other
information that have been reorganized for ease of review.
The record status bar is still available on the page and
indicates the current state of the record, and information
icons are used here as well to link to drawer content that
describes the kind of information that might be
displayed for the field that is interactive for certain fields.
So, for example, the data elements that contribute to the
determination of the FDAAA status are listed for each
record.
Farther down on the record summary page, validation
messages are listed and summarized in an easy-to-read
panel.
You can click on an individual module in the list to the right
to fix the messages associated with that module.
Once you've navigated to the module, you'll see that the
messages are listed on the top of the page and you can click on
each accordion to expand.
You can also scroll down to the relevant data element to see the
relevant messages listed in line with the entries that need
attention.
When all validations have been addressed and you return to the
record summary page, you'll see a message in yellow that
explains that you'll need to return to the classic system for
the present time to submit the record for review.
This message also clarifies that some additional revisions might
be required as we're finalizing the implementation of the
validation messaging in PRS Beta.
In the short term, users will click on the blue complete next
steps in the Classic PRS button to submit the record in the
classic system.
So in summary, enhancements to the record summary page include
more accessible content with added functionality, improved
messaging and navigation to fix errors and address warnings, and
reorganized content to facilitate user review.
So as we continue modernizing the PRS, we'll be adding the
QA/QC process for protocol registration, the results
section, and the QA/QC process for results submission.
We'll also continue to rely on user feedback to find out what
is and isn't working for everyone and we'll continue to
make improvements based on this feedback.
So with that, I'll say thank you for your attention.
And now we can move on to answering questions with the
help from our expert panel, which includes our Product Owner
Nachiket Dharker, our Subject Matter Expert with former user
expertise Maureen Strange, and our Technical Lead Ben Babics.
Thank you.
LOUISE: Thanks so much, Stacey.
So we do have a hand raised.
I think so.
From msmolloy and I guess, well, I recognize your name from last
week's Office Hour and we did pass along your questions to the
ClinicalTrials.gov team.
But I want to give you the opportunity now to unmute
yourself and prompt your questions.
And and I'll ask, since you have several questions, if you can do
them one by one, different subject matter experts are able
to answer your various questions.
So please go ahead.
msmolloy: Yes, I guess I'll start off with the last question
I posted. Will the modernized site have an audit trail?
At our institution, we often experience PIs going and
changing their primary completion date or study
completion date to 2-3 months in the past.
And so it makes it really hard to track when they make these
changes because it doesn't always notify us or they just do
it at the last minute.
So if we can see an audit trail that would be really helpful.
Just so we can track to see who's doing what and how many
are out of compliance with time points for ct.gov. NACHIKET: I
can take that one.
I think that's a great question.
So you know, I don't think we at least at this point we are
planning for to do anything different than what the classic
system is doing.
That means are all the versions that are released, you can audit
them.
So you know between every release you can in our track
what has changed but within a version that is in progress
let's say you know if you-- I think what you are trying to ask
is before a record version is released and people are making
updates, is there a way to track them? And that is very difficult
from the systems perspective right now for us to do
especially because we know that we anyways have to you know
track and provide links to the versions that have been released
and reviewed and you know that have comments.
So we are planning to continue supporting that but within a
release at this time we are not planning on doing any-- or
within progress versions
you know if there are multiple updates made on let's say
several days within several days there is no way for us to track
it at this point.
msmolloy: Thank you.
I guess my next question would be the PRS Test site doesn't
allow you to fully even input a record in the beta version.
Will that become available prior to the classic site being
inactivated?
And with that, will we receive a Training the Trainer prior to
classic site being deactivated?
STACEY: So I can answer that one, if it's okay, Nachiket.
So yeah, I mean we're not going to launch PRS as primary until
it's fully functional.
And so the classic system will not go away until we know that
the PRS beta, once it becomes primary is functioning as
expected.
So it, you know, it's really important as we continue to
release that we get feedback and we know when things are kind of
happening that are unexpected because we do try to control for
everything
but you know, there are things that kind of surprise us at
times.
And so we're hearing from folks and it's been great.
And then I think, sorry, can you repeat the second part of your
question.
msmolloy: So there's usually a Training the Trainer training
that comes out right. STACEY: Okay.
Yeah.
So actually we're in the process of planning another Train the
Trainer.
But as you know, we have sort of limited availability at any time
for the Train the Trainer.
We, I think, typically have about 30 people in attendance.
And so we typically also have maybe one person from each
representing institution or represented institution, but we
are
planning another Train the Trainer.
I don't know right now what the plan is for incorporating any
information about the beta for that Train the Trainer.
But as we're moving forward, you may be familiar that we have a
training resource called the PRS Guided Tutorials that are
associated with the classic system.
And we do plan to make updates so that those are updated to
direct people through data entry for the PRS Beta.
So we'll have that resource.
We'll be updating other resources that are linked to
entry of information into the PRS and hopefully you know in
future we do plan to continue these Train the Trainer
workshops.
So that'll definitely be something that we'll be doing
continuing into the future.
msmolloy: Okay, Thank you.
My final question is the classic site has a Problem Record tab,
which is really useful when I log in the morning.
That's the first thing I do, is check the problem records, make
sure what has changed, what hasn't changed, so I can send
out emails or verify information.
The beta site, when I go to use the Problem Record column and I
put it as my number two spot, doesn't accurately reflect the
same amount of problem records that are in classic versus beta.
And so we have a separate tab when the beta becomes the full
site for that
so we can separate out problem records or what's the plan?
STACEY: So I think what you're describing may just be there
could be some still discrepancies between how the
beta system is processing that information versus the way that
the classic system is.
But it could also have to do if you have more than 1000 records,
you might be limited by that threshold as to which records
you're seeing.
And so I think that's another issue that we're figuring out
how to display all of the records for your organization so
that you're not limited to a subset of your records and you
can see every record that has problems.
I'm going to let Nachiket address the question of the
button because he did address and you're aware of how you can
reposition the column and filter that way.
But I'll let Nachiket address the second part. NACHIKET: And
the second part was about like reintroducing the button.
Stacey, is that-- STACEY: Yes. NACHIKET: OK.
Yeah, I mean what we were hoping, I mean when we kind of
took that button away, our hope was that we are you know
introducing the problem column as like a column in the record
list.
So using the customized column options and repositioning that
column, people will be able to you know have the same kind of
experience as they were having with the problems record button.
But if if our users think that no that is not replicating or
that functionality is not going to be you know totally
completely replicating that problem records button then you
know it would be great if you can provide that feedback so
that we can take it back.
If we hear that from more users, then we'll obviously-- we want
to support the users as much as possible
so we'll reintroduce that button.
Again, as I said, our hope was that people won't need that
button if we enhance or update our record list in the way that
we have done.
But that's something that we definitely can change
If that's not helping. msmolly: Thank you so much.
I appreciate it.
NACHIKET: Sure.
We do recognize that it is a very important feature that our
users have been using.
LOUISE: OK, thank you for the questions.
We have another question from Michael.
Will the PRS test system be updated so we can practice using
the new system without doing so in the live PRS production
system?
And it looks like maybe Stacey might be able to answer this
one.
STACEY: Sure.
So I reviewed, you know that PRS Beta is available in PRS Test as
well in the as in the Production system.
And in fact any updates that we're making, we're testing out
in the Test system first.
So those who are familiar with Test realize that it's not a
system where you work on your record and then put that record
into the Production system.
They're separate systems with separate data, but it is an
environment where you can test it out and make sure that it's
working the way that you would expect it to before you try to
submit records using it from within the Production system.
So hopefully that answers the question.
LOUISE: Thank you, Stacey.
Our next question is from Low.
When customizing the column display, does that customization
carry over to the other PRS administrators using the
account? And back at you, Stacey.
STACEY: I think it's locally saved when you save your column
preferences so it wouldn't be transmitted to other admins
within your organization.
It's unique to your login.
But you know you could always share the information of which
columns you selected for with you know your colleagues if you
think it's useful for them to do the same kind of sorting.
NACHIKET: And I'll just jump in that I think and add to what
Stacey said.
I think when we planned this, the idea is behind this, you
know, is that the preference of how to customize the columns is
user based rather than organization based or, you know,
that can be transferred between administrator, administrators
and other users
because every user can have their own preference.
So that's the thought behind that.
LOUISE: Okay. Thank you.
Another question we have lined up is from Sharon Reynolds, is
there an expected date that the classic site will be
deactivated? And Nachiket you might be able to answer this
one.
NACHIKET: So the short answer is no, we don't have a date based
on what Stacey demonstrated, we have a long way to go for you
know still with PRS Beta modernization.
So you know, we have to still implement the result screens,
QA/QC, and other modules or other parts of the PRS.
And we can only even think of retiring classic PRS
once we have all the functionalities that the classic
PRS currently provides, we are able to support all those
functionalities in the Beta system.
And then you know, as Stacey also mentioned, you know, we
want to give people enough time to adapt to the new system and
then we will think about retiring the classic system.
So currently we don't have-- I cannot give you a certain date
on that.
It's still a while.
LOUISE: OK.
Thank you, Nachiket.
A question from Zuli.
We have a study that currently has a record status of public.
When the NCT number is searched in the public site, the study
does not appear.
Would you be able to provide some insight on why this may be
happening or how this can be resolved?
And I'm going to pass it over to Maureen to answer this question.
MAUREEN: Thanks Louise.
Zuli, it's a matter of timing potentially on that.
They are not automatically put on ClinicalTrials.gov the same
day you may see it as public in
PRS. I would recommend that you send an e-mail to
register.clinicaltrials.gov and they should be able to help you
with that.
And Stacey or Nachiket,
if you have anything to add, please feel free.
STACEY: Nope, that would be my guess as well that it's a timing
issue.
LOUISE: Okay.
Let's see, we have a comment from Carla.
The problem button is needed.
Please add it back.
Thank you Carla for the feedback.
I think the team has duly noted that the button is very crucial.
NACHIKET: Yep, thanks again.
Yeah, I agree.
Thanks Carla for the feedback.
Although I do just want to emphasize, I hope you have tried
the problems column and how that works and then you are making,
you know, providing this feedback.
So first please, I would really appreciate if you try out what
we have provided and if your comment stays, I'm definitely--
we are hearing this from more and more users, so we will
definitely support this request if we keep hearing about this
okay.
LOUISE: And actually, I'm sorry I've missed a question from
Jessica earlier.
Jessica asks if you send an e-mail from PRS, does it log
that in the record somewhere?
For example, will I be able to tell my colleague already
emailed Doctor X about the PRS comments in their record? And it
sounds like this is something that the ClinicalTrials.gov PRS
team has to sort of consider. Nachiket, I don't know if you
want to make a comment about this.
NACHIKET: Yeah, I mean in the beta PRS we have still not, you
know, reached a stage where we rethink the e-mail and
notification system.
I mean we do have some you know early initial thoughts and plans
based on again the feedback that we have received.
But again as you know me and Stacey have said we currently
are really focusing on the data entry screens, the protocol
screens, the QA/QC, the results data entry screen in the classic
system.
Though I think there is a limit.
I mean to answer your question-- again Stacey or Marine, feel
free to jump in.
You know there are a few you know ways where when you-- and
if you use those features then that information is saved.
For example, there is a feature available I think only to the
administrators, it's called E-mail to Owner.
And if you use that feature then that you know can be you know
that message can be saved or if there is a record log, you know,
feature at the bottom of the record.
And if any communication that is, you know that our data
submitters do using that record log that gets saved in the
record.
But besides that, I mean if you just e-mail, you know using the
e-mail icons that you know that is not currently being saved in
the classic system anywhere in the record.
Again Stacey, Maureen, feel free to chime in.
MAUREEN: Nachiket, the only thing I can offer is also to CC
your colleague on the e-mail.
You are able to add people to the e-mail itself.
LOUISE: OK, thanks Nachiket
and Maureen.
Another question from msmolloy, Will the PRS test system ever
have a point where we can receive comments from mock
protocol submission to ensure we are not making mistakes when
conducting self-training?
STACEY: That isn't really something we can support.
I know that our registration team is really busy just with
records that are submitted through the live system.
We don't have anything other than validated system generated
validation messages that the system supports to kind of warn
you about things that should be fixed that the system can
detect.
Otherwise it would require you know human intervention And and
I think it's just difficult with as many records as we have
coming through to support something like that in the test
system.
But we would direct you to the review criteria for registration
and for results.
These are available on the ClinicalTrials.gov public
website and I think also from within the PRS Beta-- or sorry,
from within the PRS.
So those would be ways to get a heads up.
You can also find some descriptions of common errors in
the PRS Guided Tutorials to try to head off some problems that
you may face when you're trying to register or submit results
for your record.
LOUISE: Thanks Stacey.
And a followup question to an earlier question asking about
when the classic site will be deactivated.
This one was asking if there is no classic site deactivation
date at the moment, is the 2024 year timeline still accurate and
I'll pass that to you, Nachiket.
NACHIKET: Yeah, I can take that.
So good question.
So the timeline for 2024, that's the timeline that we are aiming
to make PRS Beta our primary site.
So that means when you log into you know the classic system you
will be or you log into PRS, you will see the the beta screens
rather than you know seeing the classic screens as you are
seeing now.
However, that doesn't mean we are going to retire the classic
PRS. As it is happening currently with the public site,
the public site is now the modernized public site as the
primary site,
although there is a button that users can use to still you know
use continue using the classic side.
The same thing will happen with the when we you know make Beta
primary, PRS Beta primary, that we are aiming for in like in
sometime in 2024. The option to go back and continue using the
classic system will still be there.
That link will be provided because again even when we make
Beta primary that would be only the time when we think that at
least the basic important features or functions that our
users need to be able to submit protocol and results are
available.
But there'll be many more you know or several more features
that we will still need to accommodate or you know you know
implement in the Beta in the new system.
So again those are the two you know dates and I think that was
the reason for this question or confusion.
So there is 2024 is for Beta becoming primary and then as I
said, we don't have a date for retiring the classic.
LOUISE: Thanks Nachiket.
A question from Low or another question from Low, will there be
a way to view a highlighted track changes version of an
updated ClinicalTrials.gov record without clicking the
Approve and Release buttons first?
Stacey, I wonder if this is question for you.
STACEY: I think we're currently working on generating those
highlighted differences and I do think that it's still coming
after the release stage.
Of course you could always unrelease the record if you
found that you know something didn't get updated that needed
to be updated or was updated inappropriately.
So I would suggest you know reviewing before you hit the
approve and the release and then you know maybe after just to
make sure, but there is a period of time where you can grab that
record back if you need to.
LOUISE: Thanks Stacey.
And our next question-- and actually I want to acknowledge
that Carla, we saw your second comment that in reference to the
record button, I think that you've tried it and your
comments stay.
So we definitely hear you on that.
But for your follow up question or your next question, is there
any way to make the columns narrower to add more to a page
view so you don't have to keep scrolling to the right?
Can a row be highlighted as it is easy to get off track with
all the scrolling to the right?
I find the modernized PRS system very cumbersome to use and it
makes me spend at least twice as much time to conduct the same
task as in the classic system.
Maybe that's a Stacey question.
STACEY: You know, I think I might let Nachiket answer that.
NACHIKET: I mean they are different again, I think they
are different.
First of all, thanks for that feedback towards-- we do
definitely take it and
We will make it back to our team.
We already have you know some plans to you know-- we did
realize certainly you know based on the feedback that we have
been seeing that we could you know make better use of the real
estate for example and other things.
But any/all this feedback is really helping us you know
continuously improving the system.
The first part was I think or the question was I think to do
with adjusting the column width, and I think that's possible,
right?
So I mean you can change the column width by dragging or
adjusting the columns so that you can have a better view,
if that answers the question. And I think when you select a
row it does change.
Again, Stacey, Maureen feel free to jump in.
It does change or shade.
So I mean I don't know exactly what kind of highlighting would
help or are you looking for, but it does, you know point or give
that appearance to the user that that's the row that you are
using.
But yeah, I get the point about scrolling.
STACEY: I'm not sure about the row.
I know that the column will be highlighted that is currently
the focus.
But yeah, I I don't know about the row individual row.
NACHIKET: We can also look into that.
So we will note that feedback and we can again take that to
our team too.
LOUISE: Yes.
And we are seeing several other questions about scrolling from
Myra and Carrie and I'm just going to note that the team is
seeing them.
So they duly take your comments and suggestions into
consideration.
So thank you Myra, Carrie, Carla for for the comments on that.
OK, so oh good.
NACHIKET: I'll just jump in because I know Carrie has
provided that feedback earlier.
So Carrie, yes we did take that feedback back, you know, to our
team and our design team has some solutions in mind.
We are you know right now focusing of course on the QA/QC
and other parts but we definitely are going to think
about ways how we can avoid that scroll, like scroll bar within
the scroll bar.
Back to you Louise.
LOUISE: Thank you.
Yes.
I think we're seeing a lot of hand clapping and thumbs up.
So I think people are liking what they're hearing about their
comments getting considered for scrolling.
OK next question is from Diane.
Was the recent kerfuffle with very old records showing an
error regarding eligibility criteria when they had entered
it appropriately a decade or more ago when the record was
created a function of the modernization?
Can anything be done to back this concern out or be sure to
avoid future such issues?
It seems like programming that acknowledges records complete
completed years ago or before 2017 could avoid a new change,
reopening concerns with "ancient records."
STACEY: I can try to tackle that one. So it isn't a product of
Beta.
It was a validation messaging problem with the classic system
where appropriate information had not been included for age
limits and so the system not having the proper validation and
then having that validation added has created some issues
with older records.
And so I understand it's frustrating.
You see something that you think is complete and then you find
out that it didn't have complete information.
The system validations are there to make sure they're kind of a
safeguard to make sure that you've entered what you're
required to enter.
But this information was noted as required previously and just
wasn't.
I think people were relying upon system validation to make sure
that that information had been included.
So what we would ask is if you happen to notice this in a
record, if you can go in, if you have a way to fix it, you know,
please do fix it.
We understand that there are circumstances that would prevent
the being able to fix it.
And I would say write in to us for some advice.
We may have some suggestions for how to work around those
validation messages for you to update that information.
LOUISE: Thanks Stacey and I'm acknowledging-- Oh go ahead
Nachiket. NACHIKET: I would just add to Stacey's, you know,
explanation she gave.
I would just, about PRS Beta,
I would really you know request all our users to you know when
they are playing around with Beta.
You know and they notice that you know there is the data that
they are-- or you know they have reason to believe that there is
an inconsistency between what they are seeing between Classic
versus Beta.
We really want to you know know about that, because again as
Stacey's mentioned in the early in our presentation, we can you
know try so much and we do vigorous testing on multiple
rounds of testing to ensure that you know there are no issues but
that you know when it goes to the real world, you are the
users and you know we really also rely on you to let us know
about these issues and we will you know if once notified we'll
definitely act on them and try to resolve them ASAP.
But yeah, that possibility is always there and we can just try
our best to, you know, make it at least disruptive for you.
LOUISE: Yeah.
Thanks Nachiket.
And yeah, I'm just acknowledging that Yang also had the same
issues as Diane.
So I think that they're happy to hear that you were looking into
it.
So next question is from Susan.
Can we run Planning Report on the new Beta site? STACEY: So I
can answer this one too.
I did demonstrate it on a slide that one of the options in the
Saved View menu is the Planning Report set of columns.
So you can filter for those columns.
You can also filter for the public site view columns.
So that would be the way to try to obtain those columns for a
report.
LOUISE: Okay.
Thanks Stacey.
From another question from msmolloy, will the modern site
allow us to delete records that have been made public?
We have a situation where the current records should be
registered under a different institution and at this time we
cannot delete the record as it has already been made public.
And maybe Maureen, you might be able to answer this one.
MAUREEN: Yeah.
I think your best course of action is to contact
register.clinicaltrials.gov Records can be transitioned or
transferred from one sponsor to another sponsor within the
system, Stacy or Nachiket,
if you have anything to add, please do.
STACEY: No, I think you got it, Maureen.
Thanks.
LOUISE: Thanks, Maureen.
And we are coming up close to the end.
So I'm going to try to squeeze in one more question from Lorna.
We've gone in a circle with updating the record on a study
and we keep receiving error messages/clarification requests.
Yet we're not sure how to answer.
Is there live help or guides that our site can use?
STACEY: So I think the best course of action in this case if
you're running into a situation where you really aren't sure how
to address validations that you're seeing is to write into
the register@clinicaltrials.gov e-mail address and hopefully we
can help you that way.
We don't have any sort of, you know 1-800 number where you can
get immediate assistance.
But our information specialist team is really great about
getting back to people very quickly.
LOUISE: Thank you, Stacey and that does help me transition to
the close of our office hours.
So we did receive a few other questions, but I'm going to
encourage msmolloy and Jessica to please send in those
questions to the e-mail that Stacey had just mentioned.