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clinical trial phase, definitions, NIH forms E 2018

What are the phases of clinical trials?

source: https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics

Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions.

  • Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
  • Phase II trials: The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety.
  • Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
  • Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use.
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NIH Forms E 2018 Format Guidelines

https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm

Of note:

Tables: the guidance on tables seems a little more liberal than in the past:

Font size:  Must be 11 points or larger. Smaller text in figures, graphs, diagrams and charts is acceptable, as long as it is legible when the page is viewed at 100%.

Text color: You can now use any color font:

Text color: No restriction. Though not required, black or other high-contrast text colors are recommended since they print well and are legible to the largest audience.

NIH assist user roles access maintainer vs status maintainer

access maintainer can assign access to others in assist: Select the checkbox for Access Maintainer if the user is being granted authority to provide and control access to other users.

status maintainer can update the status of an entire application (eg: status “complete” or “final” or “WIP”)- Only an SO or AO from the Applicant Lead Organization can grant or revoke the Status Maintainer access level.

ORCID ID

ORCID ID (Open Researcher and Contributor ID) IS a personal digital identifier that distinguishes every researcher AND is used by NIH and Grants.gov to relate publications to grants.

a new link to access ORCID.org was added to the Personal Profile section of eRA Commons.

This will allow principal investigators to create an ORCID ID to link to their Commons account, so that their publications can be linked to their grants.

ORCID ID seems to have been established in order to help facilitate pairing of publications with awards in ERA Commons.

see attached (below) for a screen shot

Creat ORCID researcher ID

To Share with PI’s: A Summary of Changes to NIH Forms Version E-

I have generally reviewed the new forms (so called “Version E”) guidance. In general, this is not as big a change as the changes that were implemented a few years ago. But there are 4 significant changes that I see in terms of what the PI needs to know.

Forms_E_Significant_Changes_Summary

1- There 2 small change to NIH Biosketches: The first is that coded header/ expiration date that appears at the top of NIH Bisoketch forms which should now read as noted below. This is a cosmetic change. The other change in NIH Biosketch is that section D can now describe “Scholastic Performance” in addition to research. This is mostly a for doctoral students and post-docs however and will likely not apply to our researchers.

2- The NIH has a very strict new policy for appendices. Be very careful in using appendices. The guidelines are here: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-129.html

3- The NIH has replaced the traditional written sections of Human Sections with several pages of rather complex forms to be filled in. There is no way a grant manager would be able to fill these in on their own, so we will need PI input for these. I have attached an annotated version of the new forms. Once again the traditional 4 sections about human subjects are now replaced by a new set of forms. These forms will likely require us to have a better grasp on the human subjects situation before we submit the proposal.

Forms_E_Human_Subjects

4. In relation to human subjects: This change was made to the research strategy section “Clarified that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form

Federal Uniform Guidelines for Small Purchases, 3,000-150,000

updated for 2017

This is under Federal Uniform Guidance Section 200.320, see text below

link

Purchases under the simplified acquisition threshold are purchases for goods or services meeting the small purchase threshold (currently at $150,000). Therefore, all purchases between $3,000 and $150,000 can use the “small purchase procedures” stated in section 200.320 (b) which describes the procedures as “relatively simple and informal.” It states that “price or rate quotations must be obtained from an adequate number of qualified sources.” It leaves the discretion of the non-Federal entity written policy to determine the “adequate” number of qualified sources (i.e., any number greater than one) and the methods of methods of obtaining the price or rate quotations (e.g., it can be in writing, orally, vendor price list on website, or generated via online search engine). Section 200.323 also excludes the small purchases from any requirements for cost or price analysis.

For example, a purchase order for chlorine supplies in the amount $10,000 can treated a small purchase order. This purchase order requires a rate quote from at least two sources, which can be obtained in writing from two suppliers or research done on a public websites. A cost or price analysis is not required. In addition, if the chlorine is of special quality that is offered by only one company or only one company can deliver in the time frame required for the purchase order can be made under the sole source purchase provision in section 200.320 (f).