The potential for central monitoring techniques to replace on-site monitoring: findings from an international multi-centre clinical trial

PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial

2010 • 332 citations

Specific barriers to the conduct of randomized trials

2008 • 163 citations

Ensuring trial validity by data quality assurance and diversification of monitoring methods

2008 • 151 citations

The Good Clinical Practice guideline: a bronze standard for clinical research

2005 • 151 citations

Data quality assurance, monitoring, and reporting

1995 • 94 citations

Clinical trials bureaucracy: unintended consequences of well-intentioned policy

2006 • 87 citations

Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials

2009 • 85 citations

Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention

2009 • 71 citations

Toward protecting the safety of participants in clinical trials

2003 • 61 citations

Sensible guidelines for the conduct of large randomized trials

2008 • 56 citations

Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer

2006 • 46 citations

Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies — The Pre-Optimon study

2010 • 38 citations

The other side of clinical trial monitoring; assuring data quality and procedural adherence

2006 • 38 citations

Developing systems for cost-effective auditing of clinical trials

1997 • 35 citations

Quality assurance in the EORTC phase III randomised ‘boost vs. no boost’ trial for breast conserving therapy: Comparison of the results of two individual case reviews performed early and late during the accrual period

2005 • 25 citations

Promoting good clinical practices in the conduct of clinical trials: experiences in the department of veterans affairs cooperative studies program

2003 • 19 citations

Quality management of a large randomized double-blind multi-centre trial: The ACTION experience

2007 • 11 citations

Site visits in a multicenter ophthalmic clinical trial

1984 • 8 citations