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

indslide

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

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Drug Applications for Over-the-Counter Drugs (OTC)

Biologic License Application (BLA)