| ●Editorial | Kurihara M | 4-5 |
| ●A handbook for IRB members | ||
| A handbook for IRB members for GCP-regulated clinical trials | Kurihara C，Nudeshima J， Kageyama S，et al． | 7-60 |
| ●Articles | ||
| Microdosing clinical study vs. Phase 1 clinical study ─time and cost-saving benefits |
Yano T，Ikeda T， Sugiyama Y | 61-8 |
| Research on the performance and cost of Japanese clinical trial | Tsujide K，Takei T， Takahashi M，et al． | 69-84 |
| Hypocrisy of medical journals：Death merchants selling leading journals ─Second report |
Saio T，Kurihara C， Fukushima M，et al． | 85-90 |
| ●Material 1 | ||
| Guidance for Industry Computerized Systems Used in Clinical Investigations
U.S. Department of Health and Human Services，Food and Drug Administration（FDA），Office of the Commissioner（OC） |
（trans. by Nishikawa A， Yamamoto K，Fukushima M） | 91-103 |
| Guidance for Industry Computerized Systems Used in Clinical Investigation | Yamamoto K，Fukushima M | 104-6 |
| Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer
Drugs and Biologics U.S. Department of Health and Human Services，Food and Drug Administration，Center for Drug Evaluation and Research（CDER）， Center for Biologics Evaluation and Research（CBER） |
（trans. by Nishikawa A， Murayama T，Kojima S，et al．） | 107-27 |
| Selection of optimal endpoints for cancer clinical trials | Teramukai S，Fukushima M | 128-9 |
| ●Material 2 | ||
| Guideline on strategies to identify and mitigate risks for first-in-human clinical
trials with investigational medicinal products European Medicines Agency（EMEA）， Committee for Medicinal Products for Human Use（CHMP） |
（trans. by Pharmacovigilance Working Group，Kobayashi K, et al．） | 131-43 |
| On the EMEA Guideline on strategies to identify and mitigate risks for
first-in-human clinical trials with investigational medicinal products ─The impact of TGN1214 issue |
Matsumoto K, Unno T， Kobayashi K，et al． | 145-54 |
| ●Forum | ||
| In the beginning was the Word/2 | Yokota Y | 155-8 |
| Talk without a stiff back | Itoh K | 159-61 |
| Disposable needles for self-injection： Necessity of shorter needle for taking home-administered injectable medications |
Kamada I | 162-5 |
| ●Instructions for authors [English] | 167-72 | |
| ●Editor's note | Yamazaki T | 173 |