NCI CTEP 30 Day Amendment Activation Requirement

March 06, 2017

Dear Study Teams, Clinical Trials Offices, OHRS and Activation Departments: 

This is notification of a major change to the NCI Cancer Therapy Evaluation (CTEP)Clinical Trials Monitoring Branch (CTMB) Audit Guidelines.   This notice applies to all studies that fall under CTMB audit guidelines (NCTN, ETCTN, COG, ABTC, BMT CTN, CITN, and PBTC studies). Please note this rule has been in place for COG studies since April 2016. 

The CTMB Audit Guidelines have been amended to require implementation of NCI CIRB reviewed protocol amendments within 30 days of posting on the CTSU Website.  The revision states:  

 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 you?

Starting with amendments posted by Cancer Trials Support Unit (CTSU) on February 9, 2017 or later: 

Study Teams:

  1. If the Institutional Review Board (IRB) of record for your study is the NCI Central Institutional Review Board (NCI CIRB), you will now need to provide documentation to Auditors of protocol implementation (aka Activation) within 30 days.

Regulatory Staff:

  1. Upon notice of a CIRB amendment (via the group broadcasts) the summary of changes and all applicable documents will be sent to department reviewers/activation agents (via email) so they can start their review (within 24 business hours of posting).
  2. The applicable Regulatory Staff will process the OHRS paperwork and make ICF updates (if applicable) and submit to OHRS (7-10 days from date of posting) the amendment using the “Amendment – NCI: Cancer Therapy Evaluation Program (CTEP)” OHRS submit document type.
  3. Regulatory Staff will work with OHRS to follow-up with outstanding Activation Agents on day 25 to help ensure amendment implementation by day 30.

Responsible Regulatory Staff:

NCTN Regulatory Staff: Andrea Kruse, Mallory Matuszek
ECTCN Regulatory Staff: Sharon Atkinson
COG Regulatory staff: Nora Hussey and Study Specific Regulatory staff as identified in OnCore
Study Specific Regulatory Staff: As identified in OnCore

Office for Human Research Studies (OHRS):

  1. OHRS will manage these submissions via the “Amendment – NCI: Cancer Therapy Evaluation Program (CTEP)” option in OHRS submit.
  2. Submissions received via the “Amendment – NCI: Cancer Therapy Evaluation Program (CTEP)” queue, where the NCI CIRB is the IRB of Record, will be routed for activation within 24 hours of OHRS submission receipt.
  3. The OHRS Activation Team will work with NCTN Office and Regulatory Staff to send P360 reminder notices to Activation Agents on day 25. 

Activation Departments:

  1. These submissions will be routed to Activation Agents via P360 as “High Priority” similar to how dose escalation amendments are routed.
  2. Please work with OHRS and Responsible Regulatory Staff to respond to follow up requests in a timely manner to ensure that the 30 day implementation requirement is met.

Additional solutions are being developed in order to better facilitate timely implementation of these amendments.  We will reach out with more information as they are created and implemented.