PhRMA BioResearch Monitoring Committee perspective on acceptable approaches for clinical trial monitoring

Drug Information Journal

Volumn 44, Issue 4, 2010, Pages 477-483

  Usher, Roland W ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

BIMO modernization; Clinical research; Clinical trial monitoring; Critical path; Data integrity; Quality

Indexed keywords

CLINICAL RESEARCH; DECISION MAKING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; REVIEW; RISK FACTOR; TOTAL QUALITY MANAGEMENT;

EID: 77954918023     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286151004400412     Document Type: Review

References (5)

1. Eisenstein E, Collins R, Cracknell B, et al. Sensible approaches to reducing clinical trial costs. Clin Trials. 2008;5:75-84. (Pubitemid 351412376)
2. International Standards Organization. ISO 9001:2000. International standard: quality management systems - requirements. December 15, 2000.
3. Baigent C, Harrell F, Buyse M, Emberson J, Altman G. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clin Trials. 2008;5:49-55. (Pubitemid 351412372)
4. Buyse M, George S, Evans S, et al. for the ISCB Subcommittee on Fraud. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med. 1999;18:3435-3451.
5. Medical Research Council, Department of Health. MRC/DH joint project to codify good practice in publicly-funded UK clinical trials with medicines. Workstream 4: trial management and monitoring. http://www.ct-toolkit.ac.uk\-db\- documents\trial-MP.pdf (accessed June 10, 2008).