Category: Uncategorized

How Do You Define a “Study” for the Purposes of Providing Information on the PHS Human Subject and Clinical Trial Form?

July 25, 2018
By

We recognize that it may be difficult to determine whether two or more closely related protocols should be considered a single study. Generally, if you have research activities that use the same human subjects population, follow the same core research protocol and procedures, and intend to combine the data for analysis in aggregate, this would … Continue reading “How Do You Define a “Study” for the Purposes of Providing Information on the PHS Human Subject and Clinical Trial Form?”

0 Comments

What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?

July 5, 2018
By

If you are proposing a study that will include both an existing dataset and recruitment of new participants, you should provide separate inclusion forms for the existing dataset and the participants to be prospectively recruited.  The existing dataset sample can be provided on the Cumulative Inclusion Enrollment Report. You should provide the sex/gender, race, and … Continue reading “What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?”

0 Comments

New Podcast on NIH Advisory Councils: Understanding What Happens During the Second Round of Peer Review

July 5, 2018
By

Have you ever wondered why your grant application must undergo a separate round of peer review—even after a panel of experts initially weighed in on its scientific merit and provided a score to consider when making funding decisions? A new All About Grants podcast delves more into the second round of peer review at NIH … Continue reading “New Podcast on NIH Advisory Councils: Understanding What Happens During the Second Round of Peer Review”

8 Comments

The NCATS Trial Innovation Network – A Resource Supporting High Quality and Cost Effective Clinical Trials Available to You

July 3, 2018
By

Well-conducted randomized trials are considered the best method of providing evidence about the safety and efficacy of treatments to improve health. Each year, NIH Institutes and Centers spend an estimated $3-4 billion supporting clinical trial activities. These activities require high-level understanding of human biology, of manufacturing and pre-clinical research, and of regulatory requirements. The process of translating a new therapeutic from discovery to practice can be robust, but … at the same time is long and expensive – and despite the challenges inherent in complex, multi-disciplinary research sometimes too long and too expensive.

,

1 Comments

If You Run Into SAM Registration Processing Delays, We’ve Got Your Back

June 8, 2018
By

GSA now requires entities who are updating or renewing their SAM registration  to provide an original, signed and notarized letter stating that the organizational official registering the organization is the authorized administrator. The new process is slowing processing time for registrations and GSA is unable to provide estimated  processing time frames. NIH encourages applicants and recipients … Continue reading “If You Run Into SAM Registration Processing Delays, We’ve Got Your Back”

2 Comments

Now Available: Delegate Tasks When Working on Interim or Final RPPRs

May 21, 2018
By

The interim Research Performance Progress Report (I-RPPR) and final RPPR (F-RPPR) are submitted online through eRA Commons in the same format as the annual RPPR.  We’ve often been asked if working on I-RPPR and/or F-RPPR be delegated to an Assistant (ASST) role. We are happy to announce that, yes, it is now possible to delegate … Continue reading “Now Available: Delegate Tasks When Working on Interim or Final RPPRs”

2 Comments