Validation of database management system applications for clinical trials

Jay Herson

doi:10.1177/009286158702100415

Validation of database management system applications for clinical trials

Research output: Contribution to journal › Article › peer-review

Abstract

This article deals with the organization, methodology, and documentation for user-written mainframe database management system (DBMS) application programs for clinical trials. Validation is defined as a quality-building process, not an error-finding process. Both functional and structural approaches to unit testing are covered. Important differences between DBMS application programs and computational programs and their impact on validation are presented. Validation methodology is presented for data dictionary, data entry, data retrieval, and Statistical Analysis System (SAS) interface, report writing, and security applications. Computer simulation methods, batch versions of interactive programs-independent SAS listings, and shortcuts facilitated by features of certain DBMSs are presented. Recommendations are made to DBMS vendors for needed validation tools.

Original language	English (US)
Pages (from-to)	475-480
Number of pages	6
Journal	Therapeutic innovation & regulatory science
Volume	21
Issue number	4
DOIs	https://doi.org/10.1177/009286158702100415
State	Published - Oct 1987
Externally published	Yes

Keywords

Clinical trials
Database management systems
Software validation

ASJC Scopus subject areas

Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Public Health, Environmental and Occupational Health
Pharmacology (medical)

Access to Document

10.1177/009286158702100415

Fingerprint Dive into the research topics of 'Validation of database management system applications for clinical trials'. Together they form a unique fingerprint.

Cite this

@article{417c270ee97d488eb11aac5e5f4ef4d2,

title = "Validation of database management system applications for clinical trials",

abstract = "This article deals with the organization, methodology, and documentation for user-written mainframe database management system (DBMS) application programs for clinical trials. Validation is defined as a quality-building process, not an error-finding process. Both functional and structural approaches to unit testing are covered. Important differences between DBMS application programs and computational programs and their impact on validation are presented. Validation methodology is presented for data dictionary, data entry, data retrieval, and Statistical Analysis System (SAS) interface, report writing, and security applications. Computer simulation methods, batch versions of interactive programs-independent SAS listings, and shortcuts facilitated by features of certain DBMSs are presented. Recommendations are made to DBMS vendors for needed validation tools.",

keywords = "Clinical trials, Database management systems, Software validation",

author = "Jay Herson",

year = "1987",

month = oct,

doi = "10.1177/009286158702100415",

language = "English (US)",

volume = "21",

pages = "475--480",

journal = "Therapeutic Innovation and Regulatory Science",

issn = "2168-4790",

publisher = "SAGE Publications Inc.",

number = "4",

}

TY - JOUR

T1 - Validation of database management system applications for clinical trials

AU - Herson, Jay

PY - 1987/10

Y1 - 1987/10

N2 - This article deals with the organization, methodology, and documentation for user-written mainframe database management system (DBMS) application programs for clinical trials. Validation is defined as a quality-building process, not an error-finding process. Both functional and structural approaches to unit testing are covered. Important differences between DBMS application programs and computational programs and their impact on validation are presented. Validation methodology is presented for data dictionary, data entry, data retrieval, and Statistical Analysis System (SAS) interface, report writing, and security applications. Computer simulation methods, batch versions of interactive programs-independent SAS listings, and shortcuts facilitated by features of certain DBMSs are presented. Recommendations are made to DBMS vendors for needed validation tools.

AB - This article deals with the organization, methodology, and documentation for user-written mainframe database management system (DBMS) application programs for clinical trials. Validation is defined as a quality-building process, not an error-finding process. Both functional and structural approaches to unit testing are covered. Important differences between DBMS application programs and computational programs and their impact on validation are presented. Validation methodology is presented for data dictionary, data entry, data retrieval, and Statistical Analysis System (SAS) interface, report writing, and security applications. Computer simulation methods, batch versions of interactive programs-independent SAS listings, and shortcuts facilitated by features of certain DBMSs are presented. Recommendations are made to DBMS vendors for needed validation tools.

KW - Clinical trials

KW - Database management systems

KW - Software validation

UR - http://www.scopus.com/inward/record.url?scp=84973721219&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84973721219&partnerID=8YFLogxK

U2 - 10.1177/009286158702100415

DO - 10.1177/009286158702100415

M3 - Article

AN - SCOPUS:84973721219

VL - 21

SP - 475

EP - 480

JO - Therapeutic Innovation and Regulatory Science

JF - Therapeutic Innovation and Regulatory Science

SN - 2168-4790

IS - 4

ER -

Validation of database management system applications for clinical trials

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Cite this