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245 _a Selected regulations & guidance for drug studies : CFR Title 21 Food & Drugs : ICH guidelines
_cCompiled by: Clinical Research Resources
250 _aRevised ed.
_bAs of 1st April, 2004
260 _aPhiladelphia, PA
_bClinical Research Resources,
_c2004
300 _avolumes (various pagings) ;
_c19 cm
504 _aincludes index
505 _a Arzneimittelprüfung Clinical Trials standards Clinical trials Standards Drug Approval Drug Evaluation standards Drug approval Drug, Investigational standards Drugs, Investigational standards Études cliniques Normes Guideline Human Experimentation standards Legislation Lois et codes Médicaments Autorisation de mise sur le marché Session laws Statutes and codes Zulassung law codes statutes
650 _2CFR Title 21, Food & Drugs: Index to Part 11, 50, 54, 56, 312, 314: 11. Electronic records; electronic signatures 50. Protection of human subjects 54. Financial disclosure by clinical investigators 56. Institutional review boards 312. Investigational new drug application 314. Applications for FDA approval to market a new drug Proposed Amendments: 312.32. IND safety report 312.64. Invesigator reports ICH guidelines (Step 5, US: E6. Good clinical practice: consolidated guidance E2A. Clinical safety data management: definitions and standards for expedited reporting E8. General considerations for clinical trials European directive on GCP 2001/20/EC Additional guidance: Guideline for monitoring of clinical investigations Selected drug development Wen sites PhRMA principles on conduct of clinical trials Compliance manual for FDA staff (#7348.810)
690 _2 Arzneimittelprüfung Clinical Trials standards Clinical trials Standards Drug Approval Drug Evaluation standards Drug approval Drug, Investigational standards Drugs, Investigational standards Études cliniques Normes Guideline Human Experimentation standards Legislation Lois et codes Médicaments Autorisation de mise sur le marché Session laws Statutes and codes Zulassung law codes statutes
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