Adding HSCT Studies

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You can add two types of studies to your Human Studies & Clinical Trails (HSCT) form.

Full Study

To add a full study, you can select Add New Full Study in the Add Studies section of the form to directly enter your data.

You also have the option of completing all or part of a PDF version of the full study, and then importing the PDF data into your Grant Runner application. Use the Download Blank Study Form link to get a copy of the PDF form. Once you’re done filling in the form, select Import New Study to import your PDF. You can then edit the imported data, if needed.

Note: You must include a Study Title (item 1.1) and answer all of the questions 1.4.a-1.4.d before you can import your PDF. If your opportunity does not allow clinical trials, or you have not answered “Yes” to all of the questions 1.4.a-1.4.d, then any data in your PDF for sections 4 and 5 will not be imported. For assistance in answering questions 1.4.a-1.4.d, review the NIH’s Definition of a Clinical Trial.

Navigating Full Studies

The full study part of the form is long, so we’ve given each section its own editable page. As you work your way through completing the form, you can navigate back to any higher-level page by using the breadcrumb at the top of the page. At the bottom of each page is a button to return to the next higher-level page. Sections two and four also have subsections with the same navigation choices.

The sections and subsections for the Full Study are:

  1. Basic Information
  2. Study Population Characteristics
    • Inclusion Enrollment Report subsection
  3. Protection and Monitoring Plan
  4. Protocol Synopsis
    • Interventions subsection
    • Outcomes and Measures subsection
  5. Other Clinical Trial Related Attachments

When you select Add New Full Study, the first page you will see is called “Full Study Details” as shown in the image below.

full study summary page showing five sections

This page has several items to note:

  • The breadcrumb, which on this summary page is “FORM SUMMARY > FULL STUDY DETAILS”. Use it to navigate through the parts of the study form.
  • The study title, which is initially “Untitled Study” until you add your own title in Section One.
  • The heading “Full Study Details” (with help icon)
  • The list of the five sections that make up the Full Study. Each section has a box that will change color as you move your mouse across it. Each section box contains
    • Its label, such as “Section One: Basic Information” with a “caret” to the left of the section label. Clicking on the caret expands the section in a read-only mode.
    • An EDIT SECTION link to the right of the label; use it to open the section to add or edit data.
    • An icon at the far right: a red exclamation point indicates required data is missing; a green check mark indicates that no required data is missing.
  • Below the sections list is a button to “Return to Form Summary”. Selecting this re-displays the Form Summary page.

To enter data into a form section, select Edit Section to open the page for that section. Use the breadcrumb or the button at the bottom of each section page to navigate back to the Study Details page.

Section One: Basic Information

This section contains the following fields. Please refer to your funding opportunity announcement and agency-specific instructions for additional guidance.

Field Description
1.1. Study Title You must enter a unique title that describes the study. Your title will display at the top of the each page of the study.
1.2. Is this Study Exempt from Federal Regulations?

1.3. Exemption Numbers

You must answer Yes or No to this question.

If you answer Yes, you must indicate at least one Exemption Number.

1.4. Clinical Trial Questionnaire There are four required questions. Answer each Yes or No as appropriate.  If the answers to all four questions are yes, then your study meets the definition of a Clinical Trial. For assistance in answering, review the NIH’s Definition of a Clinical Trial.

The questions are:

  • 1.4.a Does the study involve human participants?
  • 1.4.b Are the participants prospectively assigned to an intervention?
  • 1.4.c Is the study designed to evaluate the effect of the intervention on the participants?
  • 1.4.d Is the effect that will be evaluated a health-related, biomedical, or behavioral outcome?
1.5. Provide the ClinicalTrails.gov Identifier (e.g., NCT87654321) for this trial, if applicable Enter your identifier. It starts with NCT and contains 8 digits. When you select the Import from ClinicalTrials.gov button, Grant Runner will check if the identifier is valid, and if so, will populate the HSCT Full Study with the following ClinicalTrials.gov fields:

  • Study Title
  • Conditions or Focus
  • Eligibility Criteria
  • Age Limits (minimum, maximum age)
  • Recruitment Status
  • Brief Summary
  • Narrative Study Description
  • Primary Purpose
  • Interventions (type, name, description)
  • Study Phase
  • Intervention Model
  • Masking
  • Allocation
  • Outcomes and Measures (name, type, timeframe, description)

The imported data will replace any previously entered data on the HSCT Full Study. After import, you can edit any of the information as necessary.  

Section Two: Study Population Characteristics

This section contains the following fields. Please refer to your funding opportunity announcement and agency-specific instructions for additional guidance.

Field Description
2.1. Condition or Focus of Study Select the Add New Condition link to enter the name(s) of the condition(s) you are studying or the focus of the study. See funding opportunity announcement and agency-specific instructions for additional guidance.
2.2. Eligibility Criteria List the study’s inclusion and exclusion criteria.
2.3. Age Limits Use these pairs of fields to enter the Minimum and Maximum Ages. Pick the relevant time unit from the drop-down menu. If data is entered for one of these field, it must be entered for both unless you select N/A (no limit) from the drop-down.
2.4. Inclusion of Women, Minorities, and Children Add an attachment, if appropriate.
2.5. Recruitment and Retention Plan Add an attachment, if appropriate.
2.6. Recruitment Status Select a value from the drop-down menu, if appropriate. Choices are:

  • Not yet recruiting
  • Recruiting
  • Enrolling by invitation
  • Active, not recruiting
  • Completed
  • Suspended
  • Terminated (Halted Prematurely)
  • Withdrawn (No Participants Enrolled)
2.7. Study Timeline Add an attachment, if appropriate.
2.8. Enrollment of First Subject Enter an Enrollment Date, and select either Anticipated or Actual from the accompanying drop-down menu. If data is entered for one of these field, it must be entered for both.
Inclusion Enrollment Report Select the Add New Inclusion Enrollment Report link to open the subsection page.

Section Three: Protection and Monitoring Plan

This section contains the following fields. Please refer to your funding opportunity announcement and agency-specific instructions for additional guidance.

Field Description
3.1. Protection of Human Subjects Add an attachment, if appropriate.
3.2. Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

If yes, describe the single IRB plan

Select Yes, No, or Not Applicable as appropriate.

If you answer Yes, you must add an attachment, describing the single IRB plan.

3.3. Data and Safety Monitoring Plan Add an attachment, if appropriate.
3.4. Will a Data and Safety Monitoring Board be appointed for this study? Select Yes or No, as appropriate.
3.5. Overall Structure of the Study Team Add an attachment, if appropriate.

Section Four: Protocol Synopsis

This section contains the following fields. Please refer to your funding opportunity announcement and agency-specific instructions for additional guidance.

Note: If your opportunity does not allow clinical trials, then this section will not be editable. If your opportunity does allow clinical trials, this section will become editable once you have answered “Yes” to all of the questions 1.4 a-d.

Field Description
4.1. Brief Summary Enter a brief description of objectives of the protocol, including the primary and secondary endpoints.
4.2. Study Design This item consists of sub items a through g, described in the following table rows.
4.2.a Narrative Study Description Enter the description of the protocol.
4.2.b Primary Purpose Select a value from the drop-down menu. Choices are:

  • Treatment
  • Prevention
  • Diagnostics
  • Supportive Care
  • Screening
  • Health Services Research
  • Basic Science
  • Device Feasibility
  • Other – if you select Other, you must also enter a description for “Other Primary Purpose”
4.2.c Interventions Use the Add Intervention link to open a subsection. All three fields are required for each intervention you add. The fields are Intervention Type (choices listed below), Name, and Description. Use the breadcrumb or Return button to re-display Section Four.

Intervention Types are:

  • Drug (including placebo)
  • Device (including sham)
  • Biological/Vaccine
  • Procedure/Surgery
  • Radiation
  • Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
  • Genetic (including gene transfer, stem cell and recombinant DNA)
  • Dietary Supplement (e.g., vitamins, minerals)
  • Combination Product
  • Diagnostic Test
  • Other
4.2.d Study Phase Select a value from the drop-down menu. Choices are:

  • Early Phase 1 (or Phase 0)
  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Other – if you select Other, you must also enter a description for “Other Study Phase”

Also answer yes or no to the question “Is this an NIH-defined Phase III clinical trial?”

4.2.e Intervention Model Select a value from the drop-down menu. Choices are:

  • Single Group
  • Parallel
  • Cross-Over
  • Factorial
  • Sequential
  • Other – if you select Other, you must also enter a description for “Other Intervention Model”
4.2.f Masking Type Select Yes or No.  If yes, you must also answer Yes or No to four masking types:

  • Participant
  • Care Provider
  • Investigator
  • Outcomes Assessor
 4.2.g Allocation Select a value from the drop-down menu. Choices are:

  • N/A
  • Randomized
  • Non-randomized
4.3. Outcomes and Measures Use the Add New Outcome or Measure link to open a subsection page. All four fields are required for each outcome or measure you add. The fields are:

  • Name: Enter the name of the individual outcome or measure
  • Type: Select one of the following
    • Primary
    • Secondary
    • Other
  • Time Frame: Indicate when a measure will be collected for analysis
  • Brief Description: Enter a brief description of the outcome or measure.

Use the breadcrumb or Return button to re-display Section Four.

4.4. Statistical Design and Power Attach a PDF formatted file.
4.5. Subject Participation Duration Enter the time it will take for each individual participant to complete all study visits. See agency-specific instructions for additional guidance.
4.6. Will the study use an FDA-regulated intervention? Answer Yes or No. If yes, attach a file that describes the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status.
4.7. Dissemination Plan Attach a PDF file.

Section Five: Other Clinical Trial Related Attachments

This section has just one item: 5.1. Other Clinical Trial-related Attachments.  Use the Add Attachment link to attach one or more files.

Note: If your opportunity does not allow clinical trials, then this section will not be editable. If your opportunity does allow clinical trials, this section will become editable once you have answered “Yes” to all of the questions 1.4 a-d.

Delayed Onset Study

To include a delayed onset study, select Add New Delayed Onset Study in the Add Studies section of the summary page. Delayed onset studies are those for which there is no well-defined plan for human subject involvement at the time of submission, per agency policies on Delayed Onset Studies.

delayed onset study page

You must provide a Study Title, answer Yes or No to the Anticipated Clinical Trial question, and add a Delayed Onset Study Justification attachment for the omission of human subjects study information.

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