1. 21 Code of Federal Regulations (CFR) Part 312
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice Consolidated Guideline (1997) Federal Register
3. Data capture from the sponsors’ and investigators’ perspectives: balancing quality, speed, and cost;Lampe;Drug Inf. J.,1998
4. Kush, R.D. et al. (2003) EClinical Trials, Planning and Implementation, Thomson/CenterWatch
5. The elegant machine: applying technology to optimize clinical trials;Kubick;Drug Inf. J.,1998