Just In Time Request

This form is dynamic, which means that requests for additional information may occur as you complete the form. Please proceed from top to bottom carefully and ensure that all fields are completed before submission.

PI Name: Test Test
Degrees: Test
Institution: Test
Department: Test
Rank/Position: Professor

Study Title

CCTS Pilot Project Team

Awardees are required to meet with their "CCTS pilot project team" on approximately a quarterly basis. Meetings are coordinated by the CCTS. While team members may include individuals selected by the CCTS, our program heavily relies on your suggestions of team members that may provide support for your project in variety of ways - mentorship, coinvestigation or cross-disciplinary perspective. Please list 3-6 individuals and email addresses that you would like the CCTS to reach out to, on your behalf, regarding involvement on your project team.

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Is this study exempt from Federal Regulations?

Yes

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Exemption catagory

Exempt Category 1: Research conducted in established or commonly accepted educational settings involving normal educational practices
Exempt Category 2: Research involving educational tests, survey procedures, interview procedures, or observation of public behavior
Exempt Category 3: Research involving benign behavioral interventions
Exempt Category 4: Secondary research uses of identifiable private information or identifiable biospecimens
Exempt Category 5: Research and demonstration projects that are conducted, supported by, or otherwise subject to the approval of a Federal department or agency on public benefit or service programs
Exempt Category 6: Taste and food quality evaluation and consumer acceptance studies

Clinical Trial Questionnaire
If the answers to all four questions below are yes, this study meets the NIH's definition of a Clinical Trial, will need to be registered and reported on in ClinicalTrials.gov, and substantially more "Just in Time" information is required.

Does this study involve human participants?

Yes

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Are the participants prospectively assigned to an intervention?

Yes

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Is the study designed to evaluate the effect of the intervention on the participants?

Yes

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Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

Yes

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ClinicalTrails.gov Identifier (e.g. NCT87654321)

Conditions or Focus of Study

For instance: cardiovascular disease, health disparities. Please list 1-20 conditions or focus of study. Plain text only.

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Eligibility Criteria

List inclusion/exclsion criteria. Do not include justifications in this field.

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Minimum Age (Years)

Maximum Age (Years)

Inclusion of Individuals Across the Lifespan

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Inclusion of Women and Minorities

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Recruitment and Retention Plan

Please upload a word document. You may use this template with instructions.

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Recruitment Status

Study Timeline

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Inclusion Enrollment Report Title:

This title should match your study title.

Are you using an existing dataset or resource?

Yes

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Please indicate enrollment location type:

Domestic

Foreign

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Please indicate the countr(ies) in which participants will be enrolled:

Enrollment Country 1
Enrollment Country 2
Enrollment Country 3

Please indicate the state(s) in which participants will be enrolled:

Enrollment State 1
Enrollment State 2
Enrollment State 3
Enrollment State 4

Please indicate enrollment location(s):

Examples: Hospital, University, Research Center. Please do not enter the name of the facility or organization.

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Enrollment Comments (OPTIONAL)

You may address information about specific subpopulations if relevant to the scientific hypothesis(es) or if inclusion monitoring is occurring as part of another study or NIH grant.

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Planned Enrollment Table

Please upload an excel document of your planned enrollment. You may use this template with instructions. This template enables submission of up to three planned enrollment tables - one table per sheet. Separate planned enrollment tables are required for domestic and foreign enrollment (where multiple foreign enrollment countries may be combined).

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Protection of Human Subjects

Please upload a word document. You may use this template with instructions.

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Is this a multi-site study that will use the same protocol to conduct nonexempt human subjects research at more than one domestic site?

Only select N/A if the study is exempt.

Yes

N/A

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Single IRB plan is no longer required for NIH applicants. However, if your study utilizes a sIRB, please state the IRB of record.

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Data and Safety Monitoring Plan

Please upload a word document. You may use this template with instructions.

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Will a Data and Safety Monitoring Board (DSMB) be appointed for this study?

Yes

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Overall Structure of the Study Team

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Detailed Description:

Please upload a word document. You may use this template with instructions.

Note: This field matches a ClinicalTrials.gov field "Detailed Description"

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Primary Purpose

Note: This field matches a ClinicalTrials.gov field "Primary Purpose". Definition: The main objective of the intervention(s) being evaluated by the clinical trial. Select one.

Other Purpose

Interventions

Note: This field matches a ClinicalTrials.gov field. Definition: Specify the intervention(s) associated with each arm or group; at least one intervention must be specified for interventional studies. For observational studies, specify the intervention(s)/exposure(s) of interest, if any. If the same intervention is associated with more than one arm or group, provide the intervention information once, then, in clinicaltrials.gov, use the Arm or Group/Intervention Cross-Reference to associate the intervention with more than one arm or group.

Intervention Type 1
Name
Description

Intervention Type 2
Name
Description

Intervention Type 3
Name
Description

Intervention Type 4
Name
Description

Intervention Type 5
Name
Description

Study Phase

Definitions may be found by searching "study phase" on clinicaltrials.gov's Data Element Definitions webpage.

Is this an NIH-defined Phase III clinical trial?

Yes

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Intervention Model

Note: This field matches a ClinicalTrials.gov field (Interventional Study Model). Definition: The strategy for assigning interventions to participants.

Masking?

Note: This field matches a ClinicalTrials.gov field (Masking). Definition: The party or parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants.

Yes

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Masked:

Select all that apply.

Participant

Care Provider

Investigator

Outcomes Assessor

Allocation

Note: This field matches a ClinicalTrials.gov field (Allocation). Definition: The method by which participants are assigned to arms in a clinical trial.

Please enter study outcome measures.

Note: This field matches a ClinicalTrials.gov fields.

Primary Outcome: "Primary outcome measure" means the outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation. Most clinical studies have one primary outcome measure, but a clinical study may have more than one. A description of each primary outcome measure (or for observational studies, specific key measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment).

Secondary Outcome: "Secondary outcome measure" means an outcome measure that is of lesser importance than a primary outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention or interventions under investigation in a clinical study and is not specified as an exploratory or other measure. A clinical study may have more than one secondary outcome measure. A description of each secondary outcome measure (or for observational studies, specific secondary measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment).

Additional definitions for Name, Timeframe and Brief Description can be found at: https://prsinfo.clinicaltrials.gov/definitions.html.

Type	Name	Timeframe	Brief Description

Statistical Design and Power

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Subject Participation Duration

Enter time it will take for each participant to complete all study visits. If unknown, indicate "unknown" or "not applicable".

Is this an applicable clinical trial under FDAAA?

To learn more, see the "Identifying an 'Applicable Clinical Trial' under FDAAA" flowchart provided by the NIH.

Yes

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Please upload a word document describing the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status.

You may use this template with instructions.

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Dissemination Plan

Please upload a word document. You may use this template with instructions.

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Study Primary Completion Date

Note: This field matches to a ClinicalTrials.gov field (Primary Completion Date). Definition: The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.

Y-M-D

Study Primary Completion Date

Anticipated

Actual

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Study Final Completion Date

Note: This field matches to a ClinicalTrials.gov field (Study Completion Date). Definition: The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant's last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.

Y-M-D

Study Final Completion Date

Anticipated

Actual

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Enrollment of the first subject (Study Start Date)

Note: This field matches to a ClinicalTrials.gov field (Study Start Date). Definition: The estimated date on which the clinical study will be open for recruitment of participants, or the actual date on which the first participant was enrolled.

Y-M-D

Enrollment of the first subject (Study Start Date)

Anticipated

Actual

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25% of planned enrollment recruited by

Y-M-D

25% of planned enrollment recruited by

Anticipated

Actual

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50% of planned enrollment recruited by

Y-M-D

50% of planned enrollment recruited by

Anticipated

Actual

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75% of planned enrollment recruited by

Y-M-D

75% of planned enrollment recruited by

Anticipated

Actual

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100% of planned enrollment recruited by

Y-M-D

100% of planned enrollment recruited by

Anticipated

Actual

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Completion of primary endpoint data analyses

Note: Completion of Primary endpoint data analyses date cannot be later than 12 months from Study Primary Completion Date (i.e. Primary Completion Date).

Y-M-D

Completion of primary endpoint data analyses

Anticipated

Actual

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Reporting of results in ClinicalTrials.gov

Note: Reporting of results in Clinicaltrials.gov date cannot be later than 12 months from Study Primary Completion Date (i.e. Primary Completion Date).

Y-M-D

Reporting of results in ClinicalTrials.gov

Anticipated

Actual

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Is this an applicable clinical trial under FDAAA?

Yes

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Does your exempt study involve existing data with identifiers?

Yes

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Does the study include a foreign component?

If yes, contact the CCTS program manager immediately as it may change the catagorization of the project and therefore the information required.

Yes

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List names of Key Personnel involved in the proposed study that contains a foreign component.

Is the proposed study ancillary to another study?

Yes

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Please enter the Title and PI of Parent Study

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Provide a summary of the parent protocol with an explanation of how the proposed study connects to it.

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Is this study collecting genomic data?

See: NIH Genomic Data Sharing

Yes

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Indicate the translational stage(s) of research:

Definitions

Preclinical

Clinical

Clinical Implementation

Public Health

Budget

The attached budget reflects your project costs. Total costs are broken down by NCATS vs cosponsorship. Projects involving multiple sites also break down costs by location. If the budget is acceptable, please answer "Yes" below. If a modified budget is required, please upload that budget here (and answer "No" below).

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Is the budget correct?

Yes

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Please upload a brief (< 500) word summary of the specific aspects of the proposed study that will be supported by NCATS funds.

A template for this summary may be:
1. X is a huge problem.
2. Our long-term goal is to solve this problem by developing Y.
3. This study will inform Y by examining if Z.
4. Specifically, NCATS funds will support our examination of Z by funding activities 1, 2, and 3 (e.g. time, supplies, services).
5. Examination of Z will inform the development of Y.

Do not include activities covered by cosponsorship.

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Please upload your IRB approval (e.g. letter or email equivalent).

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Is your study an NIH-defined clinical trial or "Greater than Minimal Risk"?

Yes

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Upload NIH formatted biosketch(es) for PIs and Key Personnel

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Upload letters attesting to the completion of Human Subjects Training for PI and Key Personnel

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Upload your approved IRB protocol

This should also include any informed consent, verbal consent, transcript(s), assent, parental permission documents and/or documentation of IRB waiver, as applicable.

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Upon completion of this form, program administrator(s) will review the information you've submitted to ensure compliance with NIH's "Just in TIme" requirements for this program. You will be contacted if questions arise. Otherwise, your "Just in Time" package will be forwarded to the NIH. You will be informed when information has been submitted and approved (i.e. when expenditures may begin posting).

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