Network Clinical Trials Quality Assurance

As a sponsor and funding agency for cancer clinical trials, DCTD is required by FDA regulations to maintain a Quality Assurance program which includes auditing and monitoring. CTEP's Clinical Trials Monitoring Branch (CTMB) oversees monitoring and auditing of all CTEP-sponsored clinical trials, as well as select studies sponsored by the Division of Cancer Prevention (DCP). The below resources provide more information on the auditing and monitoring process.

If you have questions or to report concerns about research misconduct, please contact CTMB at one of the following email addresses:

GeneralQuestionsforCTMB@nih.gov - with general questions for CTMB.
QuestionsRelatedtoCTMBGuidelines@nih.gov - for questions about the auditing and monitoring Guidelines documents.
ReportingResearchMisconductConcerns@nih.gov to report concerns about research misconduct.

Auditing and Monitoring Guidelines

NCTN and NCORP Auditing Guidelines

NCTN Auditing Guidelines (PDF) (also applies to NCORP and NCORP Research Bases)

Appendix 1 - Research Misconduct Guidance (PDF)
Appendix 2 - Regulatory Documentation Review Worksheet (Word)
Appendix 3 - Pharmacy Review Worksheet (PDF)
Appendix 4 - Participant Case Review Worksheet (Word)

ETCTN and Early Phase CTMS-Monitored Studies

ETCTN Monitoring Guidelines (PDF) (also applies to other early-phase CTMS-monitored studies)

Appendix 1 - Research Misconduct Guidance (PDF)
Appendix 2 - Regulatory Documentation Review Worksheet (Word)
Appendix 3 - Pharmacy Review Worksheet (PDF)
Appendix 4 - Participant Case Review Worksheet (Word)

CSRN Guidelines

CSRN Auditing and Monitoring Guidelines (PDF)

Good Clinical Practice (GCP) Guidelines

International Council for Harmonisation (ICH) Efficacy Guideline for GCP

E6(R2) - Effective March 2018
E6(R3) - Effective July 2025
See the ICH GCP Guidelines page for more information.