MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02312nam a22002057a 4500 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
UDS |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20230202010940.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
230202b ||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
LC |
| Language of cataloging |
ENG |
| Transcribing agency |
UDS |
| Description conventions |
RDA |
| 050 ## - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
QV20.5 |
| Item number |
C51 |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Selected regulations & guidance for drug studies : CFR Title 21 Food & Drugs : ICH guidelines |
| Statement of responsibility, etc. |
Compiled by: Clinical Research Resources |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
Revised ed. |
| Remainder of edition statement |
As of 1st April, 2004 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
Philadelphia, PA |
| Name of publisher, distributor, etc. |
Clinical Research Resources, |
| Date of publication, distribution, etc. |
2004 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
volumes (various pagings) ; |
| Dimensions |
19 cm |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc. note |
includes index |
| 505 ## - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
<br/>Arzneimittelprüfung<br/>Clinical Trials standards<br/>Clinical trials Standards<br/>Drug Approval<br/>Drug Evaluation standards<br/>Drug approval<br/>Drug, Investigational standards<br/>Drugs, Investigational standards<br/>Études cliniques Normes<br/>Guideline<br/>Human Experimentation standards<br/>Legislation<br/>Lois et codes<br/>Médicaments Autorisation de mise sur le marché<br/>Session laws<br/>Statutes and codes<br/>Zulassung<br/>law codes<br/>statutes<br/> |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Source of heading or term |
CFR 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 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) |
|---|
| Source of heading or term |
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 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Library of Congress Classification |
| Koha item type |
Books |