CRC No Tame No Chiken Gyomu Manual (GCP)
Konishi Toshio Oyake Tadashi
| Points You Earn | 1% (30p) |
|---|---|
| Release Date | September 28, 2009 |
| Availability | Sold Out |
Product Details
| Catalog No. | NEOBK-601394 |
|---|---|
| JAN/ISBN | 9784840740272 |
| Product Type | BOOK |
| Pages | 271 |
|---|
Books are basically written in Japanese except for bilingual books or ones indicated as not written only in Japanese.
Translate Description
Description in Japanese
CRCのための治験業務マニュアル (GCP) / 小西敏郎 小宅正
Related Offer & Feature
Tracklisting
| 1 |
総論 CRCに求められるもの
|
| 2 |
実務 治験全体の流れとCRC業務(治験説明会出席
|
| 3 |
治験責任医師とCRC業務に関する事前協議
|
| 4 |
院内各部署の情報聴取
|
| 5 |
CRC資料作成
|
| 6 |
治験資材の搬入・管理。治験薬搬入時の立会い
|
| 7 |
スタートアップ・ミーティング
|
| 8 |
治験開始著久瀬の最終確認
|
| 9 |
同意説明・同意取得の補助
|
| 10 |
治験適格者確認作業
|
| 11 |
被験者選択補助業務(募集広告患者の場合)
|
| 12 |
被験者の治験登録補助作業
|
| 13 |
治験開始、終了時の手続き
|
| 14 |
被験者対応例
|
| 15 |
治験担当医師対応
|
| 16 |
症例報告所作成補助作業
|
| 17 |
直接閲覧を伴うモニタリング・監査対応
|
| 18 |
有害事象発生時の対応
|
| 19 |
治験薬の休薬、治験中止ならびに脱落時の対応
|
| 20 |
逸脱時の対応
|
| 21 |
CRC業務終了に伴う対応)
|
| 22 |
付録 CRCとして地に足がついた治験支援業務を実施しよう(治験実施計画書からの逸脱事例の紹介
|
| 23 |
SDV効率化に向けたCRCの行動とは
|
| 24 |
治験薬概要書を治験支援業務に役立てよう)
|
| 25 |
資料(医薬品等の副作用の重篤度分類基準
|
| 26 |
「医薬品の臨床試験の実施の基準に関連する省令」の運用について(抜粋)
|
| 27 |
CRC業務に関連する法令・通知・資料)
|
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