Monitoring Protocol Adherence – ARCHIVED

CHAPTER SECTIONS

ARCHIVE Data and safety monitoring


Section 3

Monitoring Protocol Adherence – ARCHIVED

Contributors

It is sometimes argued that PCTs, as opposed to traditional trials, should do very little to address adherence within the trial, because adherence to an intervention can be considered a representation of how well the intervention would be implemented in the clinical setting. However, without information about adherence, it will be impossible to interpret trial results and determine whether a change (or lack of change) in outcomes was in fact due to the trial intervention.

Due to potential changes in clinical care that occur in healthcare delivery settings, monitoring for use of non-protocol interventions and the difference in adherence rates between the control and intervention arms can be an important part of the monitoring plan for ePCTs. The table below describes an example from the NIH Collaboratory Trials.

Example of Adherence Monitoring in PCTs
Trial Adherence monitoring
ICD-Pieces The trial monitors adherence to the intervention by reporting use of some key components of the intervention, including use of angiotensin converting enzyme inhibitors/angiotensin receptor blockers, use of statins, and checking hemoglobin A1c.

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SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction – Data and Safety Monitoring ARCHIVED
  2. Which PCTs Should Have a DMC? – ARCHIVED
  3. Monitoring Protocol Adherence – ARCHIVED
  4. Data Issues With Monitoring PCTs – ARCHIVED
  5. Monitoring for Serious Adverse Events – ARCHIVED
  6. Futility Assessment V. 2 – ARCHIVED
  7. Futility Assessment – ARCHIVED
  8. Case Study: Planning for Monitoring PCTs – ARCHIVED
  9. Including Stakeholder Perspectives – ARCHIVED
  10. Special Training and Resources for DMCs of Pragmatic Trials – ARCHIVED
  11. Additional Resources – ARCHIVED


Version History

July 3, 2020: Minor corrections to layout and formatting (changes made by D. Seils).

December 13, 2018: Updated text as part of annual content update (changes made by L. Wing).

Published August 25, 2017

current section :

Monitoring Protocol Adherence – ARCHIVED

  1. Introduction – Data and Safety Monitoring ARCHIVED
  2. Which PCTs Should Have a DMC? – ARCHIVED
  3. Monitoring Protocol Adherence – ARCHIVED
  4. Data Issues With Monitoring PCTs – ARCHIVED
  5. Monitoring for Serious Adverse Events – ARCHIVED
  6. Futility Assessment V. 2 – ARCHIVED
  7. Futility Assessment – ARCHIVED
  8. Case Study: Planning for Monitoring PCTs – ARCHIVED
  9. Including Stakeholder Perspectives – ARCHIVED
  10. Special Training and Resources for DMCs of Pragmatic Trials – ARCHIVED
  11. Additional Resources – ARCHIVED

Citation:

Ellenberg S, Sugarman J, Zatzick D. ARCHIVE Data and safety monitoring: Monitoring Protocol Adherence – ARCHIVED. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/ethics-and-regulatory/archive-data-and-safety-monitoring/monitoring-protocol-adherence/. Updated July 9, 2025. DOI: 10.28929/041.