PHS Human Subjects and Clinical Trials Information Form Walk-through


A walkthrough of the PHS human subjects and clinical trials information form NIH currently collects human subjects and
clinical trials information across a number of application forms we are
changing our data collection strategy for grant applications submitted to due
dates on or after January 25 2018 we will continue to use the research and
related other project information form to determine whether your application
involves human subjects research and to collect information like exemption codes
and human subject assurance numbers we will consolidate the remaining human
subjects in clinical trials information currently collected on multiple forms
into a new PHS human subjects in clinical trials information form this
new form will allow us to collect detailed study level information for the
protocols included in your application before you begin filling out the new
form make sure you’ve completed the RNR other product information form the
answers you provide on that form will try the data collection requirements for
our new form as we explore this new form keep in mind that the look and feel of
the form will be different based on whether you were using assist a system
to system solution or workspace to prepare and submit your application for
example buttons may have different labels or may be found in a different
part of the screen but all the data fields and requirements remain the same
regardless of these slight user interface differences now let’s check
out the new form if you answer no to the human subjects involved question on the
other project information form then that answer is reflected at the top of our
new form just below the pre-populated information is a section with the
heading if no to human subjects you’ll need to answer the question does the
proposed research involve human specimens and/or data if you answer yes
provide a justification for why you believe the application does not involve
human subjects research and unless your funding opportunity announcement
provides additional guidance for the form you’re done with it simple if you
answer yes to the human subjects involved question on the other project
information form your answer is again reflected at the top of the form this
time you’ll go to the section of the form with the heading if yes to human
subjects and you’ll need to provide at least one
study record that study record maybe a full detailed study record or a delayed
onset study record if you anticipate human subjects research will be done but
definite plans for this involvement cannot be described until other aspects
of your research are completed then you may meet our definition of delayed onset
entering a delayed onset study is pretty easy simply provide a study title
indicate whether one or more clinical trials are anticipated and attach a
justification your justification must describe why detailed study information
cannot be provided at the time of application and assurances that you will
comply with all applicable policies such as the use of a single IRB board for
domestic multi-site studies that will use the same protocol and a plan for the
dissemination of NIH funded clinical trial information note delayed onset is
not the same as delayed start where the information is known upfront but the
work is not done in the initial budget period unlike delayed onset we expect a
full study record for delayed start studies now let’s look at a full study
record study records are broken down into five sections the specific field
you’ll need to complete will vary based on the specifics of your application
I’ve marked the fields required for human subject studies with an HS icon
and the additional fields you must complete if doing a clinical trial with
a CT icon to help visualize requirements as we walk through the study record
section 1 includes basic information and must be completed for all studies both
those with and without clinical trials it includes a study title up to 600
characters which must be unique within the application exemption code
information where the exemption code information provided on the other
project information form was for the application as a whole this field asked
about exemption code information at the study level a clinical trial
questionnaire if you answer yes to all four questions the study will be
considered a clinical trial requiring you to provide trial specific
information and finally a clinical trials.gov identifier often referred to
as an NCT number this is an optional field since you
aren’t required to register in clinical trials.gov until 21 days after your
first participant has enrolled as we look at other sections of the study
record you may notice our form in clinical trials.gov have mini fields in
common having a place on the form to collect the identifier positions us for
future data exchange with clinical trials gov to reduce data entry and
provide more consistent information between systems the additional sections
in the study record are designed to lead you through our data collection
requirements in a structured way providing specific fields for key
information ensures each item has been given appropriate consideration it also
ensures we have the data necessary and a consistent format for review and
oversight of the study section 2 is study population characteristics you
must complete the section for all studies unless exemption 4 applies
you’ll recognize the inclusion of women minorities and children attachment from
our old forms and many of the other items in the section or structured
fields for information previously collected within the protection of human
subjects attachment the last item in this section is for inclusion reporting
all studies must include at least one inclusion enrollment report we will no
longer use the standalone PHS inclusion enrollment report form instead data
collection for up to 20 inclusion enrollment reports has been folded into
each study record for each inclusion enrollment report you’ll need to
indicate whether an existing data center resource will be used and whether the
enrollment location type is domestic or foreign there are also a few optional
fields in the report header including a text entry comment section and there are
separate tables for planned and cumulative enrollment data section 3 is
the protection and monitoring plans section it includes the protection of
human subjects attachment previously found on the research plan form you’ll
want to read through our application guide instructions for this attachment
since some of the information previously collected here is now collected on other
named fields in the form all studies must provide a protection of human
subjects attachment and answer the question regarding multi-site studies if
you propose a multi-site study that will use the same protocol to conduct
non-exempt human subjects research at more than one domestic site you’ll need
to attach your plan describing how you would comply with the NIH policy on the
use of single IRB for multi-site research the remaining fields in this
section the data safety monitoring plan attachment question about the use of a
data safety monitoring board and the overall structure of the study team
attachment are only required for studies involving clinical trials though other
studies can include them if needed section 4 is the protocol synopsis
you’re only required to complete this section for study records involving
independent clinical trials in fact you’ll receive a system error if you try
to submit information in this section for non clinical trial studies the
protocol synopsis includes a brief summary of the objectives of the study
including primary and secondary endpoints a series of fields related to
study design including a description that type name and description from 220
interventions drop-down selections for primary purpose study phase intervention
model and allocation and check boxes for masking information and the ability to
provide the name type timeframe and description for at least one but up to
50 outcome measures we’ve also included a new dissemination plan attachment used
to describe your plan for the dissemination of NIH funded clinical
trial information you’ll use this attachment to describe how you plan to
meet the expectations of NIH as new policies including the requirement to
register and report your results in clinical trials gov the final sections
section 5 is for other clinical trial related attachments which not
surprisingly is only used in clinical trial study records and only when an
attachment is specifically requested in the funding opportunity announcement to
which you are applying we’ve seen how our new PHS human subjects in clinical
trials information form consolidates human subjects information currently
scattered across multiple agency forms expands clinical trial data collection
to provide the appropriate level of information to improve oversight uses
structured data fields to lead you through key requirements provides a
consistent format for reviewers and staff to quickly find key information
and aligns with clinical trials.gov to position us for future data exchange
between systems you’ll find our updated
application forms including our new human subjects in clinical trials form
in the form Z application packages will be posting at the end of October form Z
application packages must be used for applications submitted to due dates on
or after January 25 2018 for more information about NIH s clinical trial
changes visit our web site at Grant’s dot NIH gov slash policy slash clinical
trials HTM

2 Comments

  1. Candice Klinge

    November 29, 2017 at 7:17 pm

    is there a fill-able version of the form? I can find the form but one that i can send to investigators to complete for the application since this form is embedded within the package. Our PI's don't actually complete the application package.

  2. Daniel Paulson

    January 2, 2018 at 3:07 pm

    I like the video.  This is useful.

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