SBIR/STTR

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SBIR-STTR JIT
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Definition

FDA’s information source for regulated domestic and international Small Pharmaceutical Business and Industry. CDER's Small Business and Industry Assistance (SBIA) Program’s mission of promoting productive interaction with regulated domestic and international small pharmaceutical business and industry by providing timely and accurate information relating to development and regulation of human drug products.

A service of the U.S. National Institutes of Health, ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies. Sponsors or investigators of ‘applicable’ clinical trials are required by U.S. PUBLIC LAW 110–85 Food and Drug Administration Amendments Act (FDAAA) page 82: Section 801 Expanded clinical trial registry data bank, to ‘Register’ their trials and ‘Submit Summary Results’ to ClinicalTrials.gov. Clinical studies are registered via a Web-based data entry system called the Protocol Registration and Results System (PRS).

FDA Information Sheets represent FDA’s current thinking on protection of human subjects in research.

A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information. Regulations governing the use of human subjects in research extend to use of human organs, tissues, and body fluids from identifiable individuals as human subjects and to graphic, written, or recorded information derived from such individuals.

A document filed by an institution conducting research on human subjects with the Office for Human Research Protections--HHS which formalizes its commitment to protect the human subjects prior to receiving any HHS grant funding.

ICH Efficacy Guideline 6 [E6]: GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. (see principles of ICH GCP). These ethical and scientific quality standards for trials that involve participation of human subjects ensures that the RIGHTS, SAFETY and WELLBEING of the trial subjects are protected and ensures the CREDIBILITY of clinical trial data reported.

(also see FDA’s website on ICH Guidance documents, FDA’s current thinking on GCP and Clinical Trials and Human Subject Protection)

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. An Investigational device is a device, including a transitional device, that is the object of an investigation

An Application is submitted to FDA if a drug (or biological product) not previously authorized for marketing in the US is intended to be used for the purposes of clinical investigation or, in certain cases, for the purposes of clinical treatment when no approved therapies are available.

Investigators submitting Investigational New Drug (IND) applications to FDA

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

The trial master file (TMF) is a hard copy of all the documentation relating to a clinical trial and specifically, of the documentation held by the sponsor of the clinical trial. In other words, it is the filing system containing the essential documents. See Section 8 of ICH-GCP guidelines “ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL and Selected FDA GCP/Clinical Trial Guidance Documents

Welcome to NIH’s SBIR/STTR JIT Tutorial.

To begin, please type your name and click the continue button. Please note that the lesson will not move forward unless you type your name

Congratulations! The NIH is reviewing your application for funding and has deemed it favorable based on a number of considerations. These include, as applicable, alignment with NIH's funding principles, review of the project budget, assessment of your management systems, determination of your eligibility, and your compliance with public policy requirements.

You have just received a request for JIT information. This additional information will ensure that you have sufficient levels of effort committed to the project and there is no scientific, budgetary, or commitment overlap.

This request is not a Notice of Award and does not guarantee that an award will be made. Following review of all applicable information, a determination will be made as to whether or not an award will be made. If an award will be made, special conditions, and the appropriate level of funding will be determined.

We are here to assist you with this process. If you have questions or require additional assistance, please contact your Grants Management Specialist and/or your SBIR/STTR Representative.

These acronyms are commonly used in JIT information. Click for descriptions and hyperlinks to resources.

The Help Module consists of many tools and resources to help you complete your JIT request.

• First, please note the Menu, Glossary, and Notes. You can click on them at any time.

• Second, there is a checklist that accompanies this training. Please download it now and save a copy to your computer.

• Third, we will go through a timeline, in the order best recommended to meet your deadline, gather all required documentation, and then upload it as a single file into eRA Commons.

After you have downloaded the checklist and saved a copy to your computer, click “next” to proceed to step #2.

Your checklist will look like this. Enter your due date (ex: 12/20/2016) and press <Enter> to set your countdown. You will use this checklist to track progress as you gather documentation. Once it is complete, you are ready to submit.

Step 2: Gather information based on your research subjects. Choose one of these four options.

This timeline is tailored to the research subjects option that you just chose. Click each requirement for a full description. To change your selected option, click the “previous” button at the bottom of the screen to go back and choose again.

Please begin by clicking on the first item on the timeline. At the bottom of the screen, you will see “What it means” and “What you need to do”. As you click on each requirement, be sure to check off (on your downloaded checklist) completed documents and those that are not applicable. Once all are complete, click “Submit” at the end of the timeline for further instructions.

Note the button at the bottom of the screen, “JIT Acronyms”. We’ve compiled a list of the most commonly used JIT acronyms.

Note the button at the bottom of the screen, “JIT Acronyms”. We’ve compiled a list of the most commonly used JIT acronyms..

Note the button at the bottom of the screen, “JIT Acronyms”. We’ve compiled a list of the most commonly used JIT acronyms.

Ready to submit? Have we covered all the items on your list? If so, you are ready!

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