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, 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.
Click here for CPI Exemption Request Form
Exemption Categories
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
- Specific form completion milestones
Reduced Target Exemption
- Meet all reduced form completion targets (see Reduced Target Metrics 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’s request must be approved by CIBMTR following a meeting between CIBMTR, Center Medical Director, and Center Data Management.
Reduced Target Metrics
| Requirements | Standard Targets | Reduced Target Exemption |
|---|---|---|
| Complete Critical Forms On Time | ≥ 50% Completed by Due Date | ≥ 35% Completed by Due Date |
| Complete Critical Forms Due During the Previous Trimester | ≥ 98% Complete by end of trimester | ≥ 80% 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 | ≥ 95% Complete by end of trimester | ≥ 80% Complete by end of trimester |
| Resolve Queries Placed During the Previous Trimester | ≥ 95% Complete by end of trimester | ≥ 80% Complete by end of trimester |
Near-Miss Exemption
Automatic exemption is granted if a CPI form completion target is missed by a single form or less than a 0.5% difference in one metric and all other criteria are met. Centers do not need to submit an exemption request for this exemption type. This exemption is granted after final review of trimester standings by CIBMTR leadership. This automatic exemption may not be granted if any exemption(s) were granted during the previous trimester.
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 CIBMTR CPI Exemption Request Form
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.
Centers who meet all requirements of the exemption will receive a final status of Good Standing – Exemption. If a center requests an exemption, but is able to meet the standard targets, the final status will be Good Standing.
Milestone Requirements
If a center is requesting reduced targets for a subsequent trimester, or if the center is requesting lower targets than noted above, additional milestones will be required to obtain the status of Good Standing – Exemption. These targets will generally be specific forms to complete within the existing categories (i.e., complete all forms for patients enrolled on a particular study) but could also include training objectives or quality reviews. There is no near-miss criteria for milestone requirements.