Are there special laws or regulations about conducting research that study investigators need to be aware of?
Yes, clinical research is highly regulated. Potential study investigators can begin to find more information on the website for the FDA’s Center for Drug Evaluation and Research. Quintiles suggests starting with Federal Regulations for Clinical Investigators and the Good Clinical Practice Consolidated Guideline.
Related Questions
- I am interested in conducting a research study using a commercially available drug for the approved purpose. Does the UTHSC IRB need to review this research before my study is initiated?
- Are there special laws or regulations about conducting research that clinical trial investigators need to be aware of?
- What should investigators do if they want to revise an IRB-approved research study?
