>> Project Summary


Study ConductEffective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials

Project Status: Closed


U.S. regulations1 require that sponsors be held responsible for oversight of clinical investigations to ensure protection of human subjects and the quality and integrity of resulting data. Although general guidelines for Good Clinical Practice (GCP) are described in the International Conference on Harmonization (ICH)  Guideline E6, there is latitude given regarding the extent and nature of monitoring.

Unfortunately, little empirical evidence exists to determine which practices best achieve the goals of trial monitoring stated in ICH E6 across a range of clinical trial settings. This lack of information is concerning, especially given the contention by some in the clinical research field that cumbersome monitoring practices contribute to more work and higher costs for clinical studies. One study suggests that on-site monitoring, commonly used by industry sponsors, can represent approximately 25 to 30% of trial costs.2

Because of growing concern about the effectiveness and efficiency of monitoring practices, the CTTI made monitoring the focus of its first project. 

121 CFR 312 Subpart D; 21 CFR 812 Subpart C.

2 Eisenstein EL, Lemons PW 2nd, Tardiff BE, Schulman KA, Jolly MK, Califf RM.  Reducing the costs of phase III cardiovascular clinical trials.  Am Heart J.  2005;149;482-8.


What are the goals of this project?

Identify best practices and provide sensible criteria to help sponsors select the most appropriate monitoring methods for a clinical trial, thereby ensuring reliable and informative trial results and human subjects' protection. 


What are the objectives of this project?

  • Workstream 1: Current Practices - Describe the range of current monitoring practices and examine factors that drive their adoption
  • Workstream 2: Key Quality Objectives - Define key quality objectives for monitoring clinical trials
  • Workstream 3: Building Quality into Trials - Examine ways to build quality into trials to enable more focused and efficient monitoring


What has the project accomplished?

Refer to the Products Tab for a complete list of materials and recommendations resulting from this project.


Highlighted Results

  • There is a wide variety of monitoring practices in use.
  • Choice of monitoring approach correlates with type of organizational sponsor.
  • Rationale for using any specific monitoring approach does not appear to be evidence-based.
  • Despite availability of central data, 33% or less use centralized data monitoring to guide, target, or replace site visits.


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