| ●Editorial | Kageyama S | 4-5 |
| ●The changing situation of clinical trials and support systems: actual problems and how to solve them | ||
| ・Perspective for a new framework for the SMO, the CRO, and the IRB | ||
| Round table discussion： Actual status and future possibilities of the reorganization of the SMO trade | Oshiba I，Kobayashi S， Kageyama S | 7-31 |
| Round table discussion： Reliability and validity of Central IRBs and perspectives in research governance | Rinsho Hyoka Editorial Committee | 33-52 |
| Visit to the IRB of St. Marianna University School of Medicine Hospital | Editorial Staff | 53-7 |
| The Committee Report on standard principle of the utilization of SMO | Ministry of Health, Labour and Welfare | 59-67 |
| Relation between CRO and SMO−Proper attitude of CRO and SMO− | Japanese CRO Association | 69-73 |
| Ethical guidelines for clinical research | Ministry of Health, Labour and Welfare | 75-82 |
| ・The newly developing situation of support systems for clinical trials | ||
| Competitive advantage of clinical trials in Japan and a new model for drug development with the Pharmaceutical Value Creator (PVC) | Nakamura K | 83-7 |
| Current status of SMO in the US and solutions for problems in Japan | Ninomiya K | 89-95 |
| Academic Research Organization in the U.S | Yoshida H | 97-102 |
| ・Education and improvement of for CRC/investigators: Efforts being made to these ends | ||
| Education and Certification of CRCs by the Japanese Society of Clinical Pharmacology and Therapeutics | Nakano S | 103-8 |
| Training and Certification Programs for CRCs in Japan, the US and the Europe | Niimi M | 109-14 |
| The education of CRCs in non- governmental organizations and future prospects | Nojima Y | 115-21 |
| Education for professionals associating clinical studies | Urashima M | 123-8 |
| ●Topics | ||
| Discussion on Paragraph 30 of the Declaration of Helsinki and the issue of compensation in the NDA (new drug application) trials in Japan | Kuroyanagi T，Mitsuishi T | 129-39 |
| ●Material | ||
| The participant 's continuing consent and the roles of doctors, sponsors, IRBs, and supporting organizations | Okamoto T，Kurihara C | 141-4 |
| Consent for continuing research participation. What is it and when should it be obtained ? | Wendler D，Rackoff J （trans. by Okamoto T） | 145-51 |
| Explanation of the translation of the article "Standardized reporting of Clinical PracticeGuidelines" | Saio T，Mitsuishi T | 153-5 |
| Standardized reporting of clinical practice guidelines： A proposal from the Conference on Guideline Standardization | Shiffman RN，Shekelle P， et al． （trans. by Saio T，Mitsuishi T） | 157-68 |
| Report on a study of the present status of unapproved drug use in Japan, including thalidomide | Shimizu N | 169-229 |
| ●Forum | ||
| Lack of rationality in the new market price of larger-size Growth Hormone | Kamada I | 231-2 |
| Memoir of Prof. Lasagna | Shimizu N | 233-4 |
| Drug research and the ethical/legal framework of clinical trials | Satoh T | 234-5 |
| ●Instructions for authors [English] | 237-42 | |
| ●Editor's note | Ueda K | 243 |