Human Subject Research Core

Director: Lewis, James., MD, MSCE

Summary:

The Human Subject Research Core will assist with protocol development for PenNSAM studies. It will manage regulatory compliance and implement inpatient and outpatient PenNSAM protocols including recruitment and screening of participants, implementation of study visits and procedures, as well as the collection and management of study data.

Services offered
IRB protocol and FDA IND applications
Stool Collection Methods/Materials
Dietary history instruments
Study participant payment
Case report forms
Staffing
Budgeting
Assistance with grant preparation: The core can provide assistance with grant preparation through consultation on study design, statistical analysis design, power calculations, and assisting in drafting text for analyses and translational study designs related to human diet and nutrition studies.

Affiliations:

• Penn Center for Nutritional Science and Medicine

People:

• Director: Lewis, James., MD, MSCE
  

Web Links:

• https://www.med.upenn.edu/pennsam/human-subject-research-core.html