E-Newsletter - February 2017

new addendum to ctmb audit guidelines

Effective February 9, 2017, the NCI Clinical Trials Monitoring Branch (CTMB) Audit Guidelines have been amended with the following under section 5.2:

Failure to have a CIRB approved amendment locally implemented within 30 days of notification posted on the CTSU website will result in a lesser deficiency.

What does this mean for Alliance Clinical Research Professionals? If your Institutional Review Board (IRB) of record is the Central Institutional Review Board (CIRB), at the time of audit, auditors will now need to see documentation of protocol implementation within 30 days of each CIRB approved protocol update posting dated February 9, 2017 or later. Examples of acceptable documentation are Excel spreadsheets, e-mail announcements to site staff, stamped protocol cover pages, etc.

Use the following links to access the information:
CTMB Audit Guidelines (Feb 2014): https://ctep.cancer.gov/branches/ctmb/clinicaltrials/docs/ctmb_audit_guidelines.pdf
Addendum to CTMB Audit Guidelines (Feb 2017): https://ctep.cancer.gov/content/docs/Addendum_to_CTMB_Audit_Guidelines.pdf

For additional information, contact Barbara K. Barrett, MS, CCRP, Director, Alliance Audit Program, at bbarrett@uchicago.edu.


For other articles in the February issue of the Alliance E-News newsletter, see below.