| ●Editorial | Tsubaki H | 1-3 |
| ●External quality assurance in clinical trials | ||
| ISO9000, quality management system−Discussion with Mr. T. Yano− | 5-31 | |
| Basic concept of ISO9000 QMS | Kato Y | 33-50 |
| The opening of the new era of clinical trial administration on ISO9000 | Fujita T | 51-72 |
| ＜Material＞ | ||
| Dr. O'Neill response quality assurance for clinical data management and its application | Editorial Board of “Rinsho Hyoka (Clinical Evaluation) ” | 73-6 |
| Historical remarks on development of quality management | Tsubaki H | 77-96 |
| ●Original | ||
| Long-term safety and efficacy of acetylcholinesterase inhibitor E2020 in patients with Alzheimer-type dementia−52-week open label study− | Tohgi H, Homma A, Imai Y, et al. | 97-126 |
| ●Interview | ||
| Interview with Ms. Amanda Frost about Public Citizen's activities on drug information disclosure | 127-44 | |
| ●Report | ||
| New GCP training for institution staff in Japan −A pilot course at Asahikawa Medical College− | Ishikawa M, Kuerner T, Tsutani K, et al. | 145-52 |
| ●Material | ||
| Guidance for industry : providing clinical evidence of effectivenes for human drug and biological products | FDA/CDER & FDA/CBER (Tsubaki k, Usuki H, trans) | 153-68 |
| ●News | ||
| Rinsho Hyoka included in the list of CONSORT journals | 169 | |
| ●Instructions for authors [English] | 171-6 | |
| ●Editor's note | Mitsuishi T | 177 |