Uploading Studies to ClinicalTrials.gov Just Got Easier

When conducting clinical trials, NIH funding recipients are required to register their study at ClinicalTrials.gov. To make registration easier, a new feature in the eRA Human Subjects System (HSS) allows applicants and recipients to export study record entries as an XML file, and upload fields that are captured in both systems directly into ClinicalTrials.gov’s Protocol Registration and Results System (PRS). Continue reading

Roundup of R15 Academic Research Enhancement Award (AREA) and Research Enhancement Award Program (REAP) Resources

As announced in this guide notice, NIH now administers two programs using the R15 activity code. The Academic Research Enhancement Award (AREA) targeting undergraduate-focused institutions and the Research Enhancement Award Program (REAP) targeting graduate schools of arts and sciences and health professional schools that grant baccalaureate or advanced degrees. Continue reading

Is My Ancillary Study Considered a Clinical Trial?

It depends. Yes; if the ancillary study adds an additional prospectively assigned intervention to patients or a sub-population of patients within the larger clinical trial and all elements of the NIH clinical trial definition are met. No; if the ancillary study is only adding additional measures to an existing clinical trial. Continue reading

New Resources Available for Basic Experimental Studies with Humans (BESH) Funding Opportunities

In November, NIH announced the publication of new funding opportunities specifically for Basic Experimental Studies Involving Humans (BESH). Need help determining if your research fits within the scope of a BESH funding opportunity announcement (FOA)? Check out these new resources. Continue reading