Good clinical practice : standard operating procedures for clinical researchers /
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| Imprint: | Chichester ; New York : J. Wiley & Sons, c1998. |
|---|---|
| Description: | xi, 177 p. : ill. ; 25 cm. |
| Language: | English |
| Subject: | Clinical trials -- Standards. Clinical Trials -- standards. Research Design -- standards. Clinical trials -- Standards. |
| Format: | Print Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/3781290 |
| LEADER | 03247pam a2200433 a 4500 | ||
|---|---|---|---|
| 001 | 3781290 | ||
| 003 | ICU | ||
| 005 | 20030527195500.0 | ||
| 008 | 970922s1998 enka b 001 0 eng c | ||
| 010 | |a 97041919 | ||
| 020 | |a 0471969362 (paper : alk. paper) | ||
| 035 | |a 97041919 | ||
| 035 | |a (OCoLC)37696634 | ||
| 040 | |a DNLM/DLC |c DLC |d DLC |d NhCcYBP |d OrLoB-B |d OCoLC | ||
| 050 | 0 | 0 | |a R853.C55 |b G66 1998 |
| 060 | 1 | 0 | |a QV 771 G6465 1998 |
| 082 | 0 | 0 | |a 610/.72 |2 21 |
| 245 | 0 | 0 | |a Good clinical practice : |b standard operating procedures for clinical researchers / |c edited by Josef Kolman, Paul Meng and Graeme Scott. |
| 260 | |a Chichester ; |a New York : |b J. Wiley & Sons, |c c1998. | ||
| 300 | |a xi, 177 p. : |b ill. ; |c 25 cm. | ||
| 336 | |a text |b txt |2 rdacontent |0 http://id.loc.gov/vocabulary/contentTypes/txt | ||
| 337 | |a unmediated |b n |2 rdamedia |0 http://id.loc.gov/vocabulary/mediaTypes/n | ||
| 338 | |a volume |b nc |2 rdacarrier |0 http://id.loc.gov/vocabulary/carriers/nc | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | 0 | |t Foreword / |r Tom Gallacher -- |t Clinical Research -- |t Phases of a Clinical Trial -- |t Clinical Trial Design -- |t History and Development of GCP -- |t Good Clinical Practice - What is it? -- |t Responsibilities of the Investigator -- |t Standard Operating Procedures -- |t Organisation of Clinical Trials -- |t Preparation, Approval and Review of SOPs -- |t Study Organisation and Planning -- |t Study Team: Definition of Responsibilities -- |t Study Files and Filing -- |t Local Management Requirements -- |t Review and Validation of the Protocol -- |t Review of Protocol Amendments -- |t Case Report Form (CRF) Review -- |t Investigator's Brochure -- |t Estimation of Patient Numbers -- |t Ethics Committee -- |t Indemnity, Compensation and Insurance -- |t Laboratory -- |t Pre-Study Monitoring Visits -- |t Patient Recruitment and Intention to Enrol -- |t Obtaining Personal Written Informed Consent -- |t Obtaining Informed Consent for Patients Unable to Give Personal Consent -- |t Randomisation and Stratification -- |t Blinding: Codes and Code Breaking -- |t Case Report Form (CRF) Completion -- |t Study Drugs -- |t Monitoring Visits -- |t Adverse Event and Serious Adverse Event Reporting -- |t Nursing Procedures -- |t Clinical Procedures -- |t Trial Report -- |t Archiving -- |t Audits and Inspections -- |t FDA Regulations Concerning Clinical Trials. |
| 650 | 0 | |a Clinical trials |x Standards. | |
| 650 | 1 | 2 | |a Clinical Trials |x standards. |
| 650 | 2 | 2 | |a Research Design |x standards. |
| 650 | 7 | |a Clinical trials |x Standards. |2 fast |0 http://id.worldcat.org/fast/fst00864439 | |
| 700 | 1 | |a Kolman, Josef. |0 http://id.loc.gov/authorities/names/n97803097 |1 http://viaf.org/viaf/7919854 | |
| 700 | 1 | |a Meng, Paul. |0 http://id.loc.gov/authorities/names/n97803098 |1 http://viaf.org/viaf/74685452 | |
| 700 | 1 | |a Scott, Graeme. |0 http://id.loc.gov/authorities/names/n97803100 |1 http://viaf.org/viaf/271025622 | |
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| 903 | |a HeVa | ||
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| 928 | |t Library of Congress classification |a R853.C55 G66 1998 |l JCL |c JCL-Sci |i 3898619 | ||
| 927 | |t Library of Congress classification |a R853.C55 G66 1998 |l JCL |c JCL-Sci |e CRERAR |b 51996031 |i 6217422 | ||
