CIBMTR acknowledges a site may have difficulty achieving CPI requirements in a given trimester due to extenuating circumstances such as staff shortages / turnover or other unforeseen challenges. To assist sites in meeting CPI requirements in these difficult situations, the CIBMTR has established the CPI Exemption Request process.

  • If a site initiates this process and the request is approved by CIBMTR, the center’s status will be noted as “Good Standing – Exemption” indicating the center did not meet the required CPI requirements in the current trimester but was allowed to “pass” the trimester with an exemption to specific CPI criteria.
  • If center was granted an exemption (any exemption) in the previous trimester, the center must provide a Corrective Action Plan (CAP) and / or Process Improvement Plan (PIP) to include at least 3 milestones.

Example Timeline

US CPI Trimesters Week 2 Week 6 Week 8 Week 12 Week 16
US Tri#1 January – April January 15 February 15 February 28 March 31 April 30
US Tri#2 May – August May 15 June 15 June 30 July 30 August 31
US Tri#3 September – December September 15 October 15 October 31 November 30 December 31
Non-US CPI Trimesters Week 2 Week 6 Week 8 Week 12 Week 16
NonUS Tri#1 March – June March 15 April 15 April 30 May 31 June 30
NonUS Tri#2 July – October July 15 August 15 August 31 September 30 October 31
NonUS Tri#3 November – February November 15 December 15 December 31 January 30 February 29

Exemption Categories (centers must fall into one of these areas):

Custom Form Exemption

  • Must meet all CTA requirements
  • Must meet all IRB requirements
  • Center’s exemption request must be approved by CIBMTR following a meeting between CIBMTR, Center Medical Director, and Center Data Management. The meeting will establish:
    • Custom form completion targets
    • Corrective action plan or process improvement plan to include at least 3 milestones

Reduced Target Exemption

  • Meet all reduced form completion targets (see Reduced Target table below)
  • Must meet all CTA requirements
  • Must meet all IRB requirements
  • If center was granted an exemption (any exemption) in the previous trimester, the center must provide a corrective action plan or process improvement plan to include at least 3 milestones

Reduced Targets

(As the CPI requirements are updated over the next several trimesters, this table will be updated to include the most current targets.)

Requirement Sept – Dec 2021 Targets Reduced Target Exemption
Complete Critical Forms On-Time ≥ 25% Completed by Due Date ≥ 15% Completed by Due Date
Complete Critical Forms Due During the Previous Trimester ≥ 90% Complete by end of trimester ≥ 75% Complete by end of trimester
Complete Study Supplemental Forms Due During the Previous Trimester 100% Complete by end of trimester ≥ 90% Complete by end of trimester
Complete All Other Forms Due During the Previous Trimester ≥ 75% Complete by end of trimester ≥ 60% Complete by end of trimester
Resolve Queries Placed During the Previous Trimester ≥ 90% Complete by end of trimester ≥ 75% Complete by end of trimester

Near-Miss Exemption

• Automatic exemption granted if a CPI form completion target is missed by a single form or less than a 0.5% difference in one metric. Centers do not need to submit an exemption request for this exemption type. This exemption is granted after final review of trimester standings.
• This automatic exemption will not be granted however, if any exemption(s) were granted during the previous trimester.
• Only allowed once per calendar year
• Must meet all CTA requirements
• Must meet all IRB requirements

Process for Requesting CPI Exemption

Step 1. If center determines they will need to request an exemption for the current trimester, the center should access the exemption request via this link. This link is ONLY active until the 6th week of the trimester.
CIBMTR CPI Exemption Request

Step 2. Center should complete the form detailing:

  • Exemption requested (Reduced Target or Custom)
  • CPI requirements that cannot be met
  • Description of the issue preventing the center from meeting all CPI requirements
  • Plan to resolve the issues
  • Provide proposed milestones, if applicable

Step 3. CIBMTR Data Operations Leadership team will review the request and respond within three weeks

Corrective Action Plan and / or Process Improvement Plan (PIP) Expectations

If a center’s request for a CPI exemption is approved, and the center had requested an exemption for the previous trimester, a Corrective Action Plan (CAP) and / or Process Improvement Plan (PIP) will be required. The CAP and / or PIP must outline the center’s plan to address the circumstances which led to a CPI exemption. The plan must identify the issue requiring action, identify methods to address the issue and include a root cause analysis, if applicable.

In addition, the CAP and / or PIP must include a plan for milestone reporting and target dates for each milestone. A minimum of three milestone reports will need to be submitted to the CIBMTR prior to the end of the trimester. All milestone reports must be submitted by the due date to receive a standing of “Good Standing – Exemption”. If all milestone reports are not submitted, the site will drop to a “First Warning” standing.

Milestone Report Components

Address reasons for exemption (examples below):

  • Exemption Request Reason: Staff training or staff shortage
    • Milestone Report Expectation: Address the center’s interim work to improve staff training or hiring
  • Exemption Request Reason: Competing CIBMTR requests
    • Milestone Report Expectation: Address the center’s work regarding their competing CIBMTR requests and their plan to meet their CPI reduced target by the end of the trimester
  • Exemption Request Reason: Logistics / Infrastructure
    • Milestone Report Expectation: Address the center’s progress on the logistics / infrastructure issues and the plan to meet their CPI reduced target by the end of the trimester

Supporting documentation:

  • Provide source documentation to verify what was reported in the milestone report
  • Identify which milestones / actions have been completed and which source documentation is in support of this
Last modified: Sep 14, 2021