Selected regulations and guidance for drug studies as of April 1, 2004:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
Philadelphia, PA
Clinical Research Resources
c2004
|
| Series: | Code of federal regulations: ICH guidelines
|
| Subjects: | |
| Item Description: | 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) |
| Physical Description: | Getr. Zählung 19 cm |
Staff View
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Record in the Search Index
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| genre | Guideline Legislation |
| genre_facet | Guideline Legislation |
| id | DE-604.BV035038806 |
| illustrated | Not Illustrated |
| index_date | 2024-07-02T21:52:29Z |
| indexdate | 2024-07-09T21:20:47Z |
| institution | BVB |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-016707662 |
| oclc_num | 56044588 |
| open_access_boolean | |
| owner | DE-29 |
| owner_facet | DE-29 |
| physical | Getr. Zählung 19 cm |
| publishDate | 2004 |
| publishDateSearch | 2004 |
| publishDateSort | 2004 |
| publisher | Clinical Research Resources |
| record_format | marc |
| series2 | Code of federal regulations: ICH guidelines |
| spelling | Selected regulations and guidance for drug studies as of April 1, 2004 compiled, updated and formatted by Clinical Research Resources Code of federal regulations: ICH guidelines CFR Title 21 food & drugs revised as of April 1, 2004 ICH guidelines (Step 5, US) European directive on GCP 2001/20/EC Philadelphia, PA Clinical Research Resources c2004 Getr. Zählung 19 cm txt rdacontent n rdamedia nc rdacarrier 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) Clinical Trials / standards Drug Approval Drug, Investigational / standards Drug Evaluation / standards Human Experimentation / standards Clinical Trials standards Drug Evaluation standards Drug, Investigational standards Human Experimentation standards Arzneimittelprüfung (DE-588)4128030-1 gnd rswk-swf Zulassung (DE-588)4127410-6 gnd rswk-swf Guideline Legislation Arzneimittelprüfung (DE-588)4128030-1 s Zulassung (DE-588)4127410-6 s DE-604 |
| spellingShingle | Selected regulations and guidance for drug studies as of April 1, 2004 Clinical Trials / standards Drug Approval Drug, Investigational / standards Drug Evaluation / standards Human Experimentation / standards Clinical Trials standards Drug Evaluation standards Drug, Investigational standards Human Experimentation standards Arzneimittelprüfung (DE-588)4128030-1 gnd Zulassung (DE-588)4127410-6 gnd |
| subject_GND | (DE-588)4128030-1 (DE-588)4127410-6 |
| title | Selected regulations and guidance for drug studies as of April 1, 2004 |
| title_alt | Code of federal regulations: ICH guidelines CFR Title 21 food & drugs revised as of April 1, 2004 ICH guidelines (Step 5, US) European directive on GCP 2001/20/EC |
| title_auth | Selected regulations and guidance for drug studies as of April 1, 2004 |
| title_exact_search | Selected regulations and guidance for drug studies as of April 1, 2004 |
| title_exact_search_txtP | Selected regulations and guidance for drug studies as of April 1, 2004 |
| title_full | Selected regulations and guidance for drug studies as of April 1, 2004 compiled, updated and formatted by Clinical Research Resources |
| title_fullStr | Selected regulations and guidance for drug studies as of April 1, 2004 compiled, updated and formatted by Clinical Research Resources |
| title_full_unstemmed | Selected regulations and guidance for drug studies as of April 1, 2004 compiled, updated and formatted by Clinical Research Resources |
| title_short | Selected regulations and guidance for drug studies as of April 1, 2004 |
| title_sort | selected regulations and guidance for drug studies as of april 1 2004 |
| topic | Clinical Trials / standards Drug Approval Drug, Investigational / standards Drug Evaluation / standards Human Experimentation / standards Clinical Trials standards Drug Evaluation standards Drug, Investigational standards Human Experimentation standards Arzneimittelprüfung (DE-588)4128030-1 gnd Zulassung (DE-588)4127410-6 gnd |
| topic_facet | Clinical Trials / standards Drug Approval Drug, Investigational / standards Drug Evaluation / standards Human Experimentation / standards Clinical Trials standards Drug Evaluation standards Drug, Investigational standards Human Experimentation standards Arzneimittelprüfung Zulassung Guideline Legislation |