Additional Resources – ARCHIVED

CHAPTER SECTIONS

ARCHIVE Data and safety monitoring


Section 11

Additional Resources – ARCHIVED

Contributors
Resource Description
Data and Safety Monitoring in Pragmatic Clinical Trials (Greg Simon, MD, MPH, and Susan Ellenberg, PhD) December 8, 2017, PCT Grand Rounds presentation, available as a webinar, slide set, and podcast.
Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in Clinical Trials: A Practical Perspective. (Second edition). Wiley; 2019 Provides a practical overview of data monitoring in clinical trials, including the purpose, responsibilities, and operation of DMCs. Useful for those managing and conducting clinical trials and those serving on DMCs or regulatory and ethical committees.
Irving E, van den Bor R, Welsing P, et al.  Series: Pragmatic trials and real world evidence: Paper 7. Safety, quality and monitoring. J Clin Epidemiol. 2017 Describes practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice.
DeMets DL, Furberg CD, Friedman LM. Data Monitoring in Clinical Trials: A Case Studies Approach. Springer; 2006. A collection of cases are used to explore issues in data monitoring of clinical trials.
CTTI’s DMC recommendations While not specific to ePCTs, the recommendations address the role of the DMC, DMC composition, communication among DMC members and other stakeholders, the DMC charter, and issues related to DMC training.
Ethical and Regulatory Issues in Pragmatic Clinical Trials: Special Issue of Clinical Trials This page provides background and links to a series of 12 articles on the ethics and regulatory challenges in pragmatic clinical trials. Each article in the special issue of Clinical Trials describes an issue in detail (e.g., privacy, informed consent) and, where possible, attempts to provide guidance for future pragmatic clinical trials.

Previous Section

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 8, 2020: Added link to journal article to Resource table (change made by L. Wing).

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

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

Published August 25, 2017

current section :

Additional Resources – 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: Additional Resources – 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/additional-resources/. Updated July 9, 2025. DOI: 10.28929/048.