A standard computable clinical trial protocol: The role of the BRIDG model

Drug Information Journal

Volumn 41, Issue 3, 2007, Pages 383-392

  Willoughby, Cara ^a   Fridsma, Doug ^b   Chatterjee, Lisa ^c   Speakman, John ^d   Evans, Julie ^e   Kush, Rebecca ^e  

^a ELI LILLY AND COMPANY   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^c Digital Infuzion   (United States)

^d NATIONAL CANCER INSTITUTE   (United States)

^e Clinical Data Interchange Standards Consortium   (United States)

Author keywords

BRIDG; Clinical research; Model; Protocol; Standard

Indexed keywords

ARTICLE; BIOINFORMATICS; BIOMEDICAL RESEARCH INTEGRATED DOMAIN GROUP MODEL; CLINICAL PROTOCOL; CLINICAL TRIAL; DATA BASE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HEALTH LEVEL 7; INFORMATION PROCESSING; MEDICAL DOCUMENTATION; MEDICAL RESEARCH; PRIORITY JOURNAL; STANDARDIZATION;

EID: 34248382004     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150704100312     Document Type: Article

References (15)

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6; 1996.
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Structure and Content of Clinical Reports E3; 1995.
3. European Clinical Trials Database - EudraCT. Available at: http://eudract.emea.eu.int/. Accessed March 15, 2007.
4. CDISC Study Data Tabulation Model. Available at: http://www.cdisc.org/ models/sdtm/v1.1/index.html. Accessed March 15, 2007.
5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Structure and Content of Clinical Reports E9; 1998.
6. Kush, R. Can clinical trial protocols be standardized? Next Generation Pharm. 2005;92-95.
7. Protocol standard - protocol representation spreadsheet. Available at: http://www.cdisc.org/standards/PRElements_FullList2-0-0.pdf. Accessed March 15, 2007.
8. CDISC Glossary Group. Clinical research glossary, version 4.0. Appl Clin Trials. 2005;14(special resource issue):24-51.
9. FDA Final Guidance (Specifications - SDTM). Available at: http://www.fda.gov/cder/regulatory/ersr/Studydata-v1.3.pdf. Accessed March 15, 2007.
10. caBIG. Available at: https://cabig.nci.nih.gov/. Accessed March 15, 2007.
11. BRIDG. Available at: http://www.bridgproject.org. Accessed March 15, 2007.
12. FDA announces standard format that drug sponsors can use to submit human drug clinical trial data. FDA News. July 21, 2004:4-73.
13. CDISC Business Case. Available at: http://www.cdisc.org/publications/ index.html. Accessed March 15, 2007.
14. ClinicalTrials.gov. Available at: http://www.clinicaltrials.gov/ct/info/ resources. Accessed March 15, 2007.
15. WHO registration dataset. Available at: http://www.who.int/ictrp/ data_set/en/index.html. Accessed March 15, 2007.