IRB-HSR Home Institutional Review Board for Health Sciences Research
For: 
Researchers IRB Members Research Subjects IRB STaff


 

 

 

 

 

 

+ Calendars & Deadlines
+ Office Information
+ Directions & Hours
+ Staff Directory
+ Frequently Asked Questions
+ IRB-HSR Membership Lists
+ FWA Information
+ Organizational Charts
+ Research Concerns
+ Standard Operating Procedures
 
+ Getting Started
+ Protocol Review Process
+ Managing Protocol After Initial Approval
+ Special Issues
   
+ Protocol Builder and IRB On-Line: On Grounds or UVa VPN access only
+ Forms
+ CITI Training
+ Education
+ Regulations/Guidelines
+ Ethical Principles
+ Search IRB-HSR Protocols
+ Glossary/Acronyms
+ Useful Websites
   
+ Go to full list >>

 

IRB-HSR > Special Issues > Drugs and Biologics > Drugs Study Record Requirements

 

 

 

 

 

 

Drugs Study Record Requirements

IRB-HSR Procedures

  1. Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under Sec. 312.5947.
  2. Case histories. An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses` notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.
  3. Record retention. An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.

*Taken from UVa IRB-HSR Research Guidance