SCOPUS 정보 검색 플랫폼

Drug Information Journal

Volumn 35, Issue 3, 2001, Pages 721-730

Electronic record challenges for clinical systems

(1) Olson, L a

a SEC Associates Inc ^* (United States)

Author keywords

21 CFR 11; Clinical applications; Clinical database; Computer systems; Computer validation

Indexed keywords

ARTICLE; CLINICAL RESEARCH; COMPUTER PROGRAM; COMPUTER SYSTEM; DATA BASE; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; INFORMATION PROCESSING; PRIORITY JOURNAL; VALIDATION PROCESS;

EID: 0034845194 PISSN: 00928615 EISSN: None Source Type: Journal
DOI: 10.1177/009286150103500310 Document Type: Article

Times cited : (3)

References (10)

1
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- Federal Register. Vol. 62, No. 54, March 20, 1997. Preamble to 21 C.F.R.11, comments 82 and 83

2
- 0004066218
- Rockville, MD: Food and Drug Administration; April
- (1999) Guidance for Industry: Computerized Systems Used in Clinical Trials

3
- 0003814999
- Code of Federal Regulations. Title 21, Parts 54.6 and 312.57. Food and Drug Administration

4
- 0003868615
- Code of Federal Regulations. Title 21, Part 314.80(i). Food and Drug Administration

5
- 0004320391
- Chicago, IL: Cohasset Associates, Inc.
- (1999) Authentic Electronic Records: Strategies for Long-Term Access
- Dollar, C.M.¹

6
- 0004584408
- Software purchase and GCP compliance
- September
- (1996) Appl Clin Trials , pp. 71-75
- Stokes, T.¹

7
- 84993782283
- Installing GCP systems at investigator sites
- January
- (1997) Appl Clin Trials , pp. 46-50
- Stokes, T.¹

8
- 0003883768
- Leveraging a supplier's verification
- January
- (1999) Appl Clin Trials , pp. 32-36
- Stokes, T.¹

9
- 0003815004
- Interactive voice response technology as a management tool for clinical trials
- February
- (1998) Appl Clin Trials , pp. 30-34
- O'Shea, K.¹

10
- 0003802921
- Warning Letter issued to Medical Industrial Equipment Ltd., item 10. Rockville, MD: Food and Drug Administration, Center for Devices and Radiological Health; June 8
- (2000)

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.