Data quality of the clinical trial process - Costly regulatory compliance at the expense of scientific proficiency

Quality Assurance Journal

Volumn 8, Issue 3, 2004, Pages 177-182

  Lörstad, Mats ^a  

^a LINKÖPING INSTITUTE OF TECHNOLOGY   (Sweden)

Author keywords

Good clinical practice; Good manufacturing practice; Process analytical technology; Quality assurance; Quality declaration; Quality management

Indexed keywords

CLINICAL RESEARCH; COMPLIANCE (PHYSICAL); COST BENEFIT ANALYSIS; DOCUMENTATION; GOOD CLINICAL PRACTICE; GOOD MANUFACTURING PRACTICE; MANAGEMENT; MEDICAL INFORMATICS; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; STANDARDIZATION;

EID: 4344680486     PISSN: 10878378     EISSN: None     Source Type: Journal    
DOI: 10.1002/qaj.288     Document Type: Review

References (8)

1. ICH Harmonised Tripartite Guideline for Good Clinical Practice.
2. Knatterud GL, Rockhold FW, George SL, et al., Guidelines for quality assurance in multicenter trials: a position paper. Control Clin trials. 1998; 19:477-493.
3. Lörstad, MH: From 'Too Much, Too Late' to 'Right First Time'; Quality Guru Deming's Advice for Clinical Trials. Drug Inf J 2000; 34:1319-1328.
4. Radford GS: The Control of Quality in Manufacturing. Ronald Press: New York, 1922.
5. Shewhart WA: Economic Control of Quality of Manufactured Product. D van Nostrand Company: New York, 1931.
6. Lörstad MH: Variation in Clinical Research - Who Wants to Know? Conference Proceedings, First International Symposium on Industrial Statistics. Linköping: Sweden, 1999.
7. Statistics Canada: Statistics Canada's Quality Assurance Framework, 2002.
8. FDA, Draft Guidance for Industry - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, August 2002.