Research Support
Our Clinical Research Support Program provides a pool of trained, certified research nurses and coordinators to assist you with study implementation. Whether you are in the UAB Hospital, The Kirklin Clinic, the Birmingham VA Medical Center, or Children’s of Alabama, we provide services when and where needed.
Services
- Interpretation and adherence to regulatory requirements
- Organizational and budget management
- Communication with sponsors
- Internal quality measures
- Data management
Fees
Access a list of Clinical Research Support Program (CRSP) fees here (BlazerID & login required).
Investigational New Drug and Investigational Device Exemption Assistance
Assistance is available to any investigator on campus who is interested in submitting an Investigational New Drug (IND) or Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA). Services include consultation, hands-on support during IND preparation, and IND management.
Our mission is to make an IND/IDE application doable for any investigator on campus.
Resources
Regulatory Issues: How to Apply for an IND
Presentation by Penny Jester and Maaike Everts
FDA Applications
Investigational New Drug (IND) Application
Investigational Device Exemption (IDE) Application
Abbreviated New Drug Application (ANDA)
