Vol.28, No.2, Jan. 2001 Support systems for clinical trials under the new GCP
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| contents |
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| ●Editorial | Kageyama S | 179-82 |
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| ●Support systems for clinical trials under the new GCP | | |
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| 1，SMO (Site Management Organization) | | 183-227 |
| SMO in Japan, present and future | Ninomiya K | 184-8 |
| Development of SMO in Japan−Self-restraint proposal by JACIC− | Kikuchi Y | 189-97 |
| Development of SMO in Japan−Japan SMO Network− | Tazawa H & Ohishi H | 198-201 |
| Roles of SMO in Japan−Regional clinical trial network− | Yuzurihara K & Konishi M | 202-8 |
| Development of SMO in Japan−SMO for specific diseases, osteoporosis− | Saito T | 209-12 |
| Roles of SMO viewed from regulatory authority | Takimura K | 213-5 |
| Expected roles of SMO by pharmaceutical industry | Imamura K | 216-20 |
| SMO in US, history and future | Ninomiya K | 221-7 |
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| 2，CRO (Contract Research Organization) | | 229-54 |
| CRO in Japan, present and future | Nakamura K | 230-5 |
| Roles of CRO | Sato T | 236-42 |
| Expected roles of SMO by pharmaceutical industry | Yuge T | 243-8 |
| Bridging study, the roles of CRO and cooperation among Japan, US, and Europe | Bareilles ME, Madono G & Asami T | 249-54 |
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| 3，CRC (Clinical Research Coordinator) | | 255-96 |
| CRC in a university hospital | Uchida E | 256-61 |
| CRC viewed from CRO | Sato T | 262-5 |
| CRC training course−Japanese Nursing Association− | Tokunaga Y | 266-72 |
| CRC training course−Ministry of Education− | Shimai T | 273-9 |
| CRC training course−Japan Pharmacists Education Center− | Yamamoto A | 280-4 |
| CRC training course−Japanese Society of Hospital Pharmacists− | Kamiya A | 285-7 |
| Training program for CRC−Quintiles− | Sato T | 288-90 |
| Qualification of CRC−Nurse's view− | Ibe T | 291-3 |
| Qualification of CRC−Pharmacist's view− | Kamiya A | 294-6 |
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| 4，IRB (Institutional Review Board) | | 297-309 |
| Roles of Central IRB | Kageyama S | 298-300 |
| Roles of Central IRB−View of small-sized institution− | Abe J | 301-4 |
| Independent IRB in US | Ninomiya K | 305-9 |
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| 5，Public recruitment of subjects | | 311-36 |
| Public recruitment of subjects−Physician's view− | Ueda K | 312-6 |
| Information for recruitment of subjects | Kanazawa S | 317-9 |
| Subjects recruitment through mass media−Antidepressant− | Wada Y | 320-6 |
| Call center system for subject recruitment−Osteoporosis− | Watanabe T & Ohgaki Y | 327-32 |
| Public recruitment of subject−Consumer's view− | Yoshikawa S | 333-6 |
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| Material | | 337-9 |
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| ●Article | | |
| Patient registration in clinical trials−Its role and ways to improve it− | Yanagimoto T & Hamano T | 341-9 |
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| ●Topic | | |
| Practice and future view of education in biostatistics | Takeuchi M | 351-69 |
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| ●Instructions for authors [English] | | 371-6 |
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| ●Editor's note | Nakajima A | 377 |