CIBMTR has revised the CPI Standards to better align the requirements with the data needs of the transplant community as well as to simplify the metrics tracked to improve the quality and availability of research data. These updates will streamline the overall process as well as increase the quality and quantity of data available for research.
– CIBMTR will implement the updated requirements for US centers on September 1, 2021. The implementation will be a phased-in approach to ensure all centers are able to meet the new requirements with minimal disruption in their current processes. Details on the requirements for each trimester are listed on the CPI Requirement Rollout page.
– CIBMTR will begin to implement the updated requirements for non-US centers on July 1, 2022. As with US Centers, the implementation will be a phased-in approach. Communication regarding more specific dates will be provided in the coming months.
Data Transmission and IRB Documentation CPI Standard
No Change to Current DTA/MHA Requirements
- The NMDP (Contracts) must have an executed Data Transmission Agreement (DTA) or an updated Master Healthcare Data and Sample Submission Agreement (MHA)
Current IRB Continuing Approval of Consent Documents Requirements (US Centers only)
- The CIBMTR must have current IRB documents (renewal letters and consents) including the following:
- Current IRB documents
- Approval letters
- Approved consent forms
Minimal Enhancements to Current IRB Approval Requirement:
- Renewal approval documentation submitted to CIBMTR must be received by the end of trimester.
- No patients consented during an approval lapse.
Consecutive Transplants Audit (CTA) CPI Standard
Current CTA Requirements
No Change to Current CTA Requirements
- Submit a complete list of all HCTs performed in the previous calendar year
- Register all HCTs performed in the prior calendar year, including subsequent transplants
- Resolve discrepancies (i.e. mismatches) found between center-provided lists and FormsNet3
- Resolve queries placed on forms with mismatched data
TED / CRF Form Submission CPI Standard
(Most CPI changes have occurred with this standard. See below for details)
Enhancements to Current TED / CRF Form Completion Requirement:
NEW! Due Date in FormsNet
Form DUE DATES, as specified in FN3, will now be the date that determines whether a form has been submitted on time to meet the CPI requirement (in the past it was the earliest complete date). The DUE DATE will encompass a grace period to ensure appropriate amount of time to complete the form.
- Here is how CIBMTR defines these dates:
- Event Date – the date that all other dates are based on, usually the infusion date
- Earliest Complete Date – the first date CIBMTR would expect to receive data for that form.
- Due Date – the date by which CIBMTR expects to receive the data whenever possible. For Critical Forms, the form must be completed by this date in order to meet the On-Time critical forms requirement
- CPI Deadline – the end of the trimester after the due date, when center are held accountable for most metrics
NEW! Designation of Critical Forms
CIBMTR has identified a group of forms (see below) that will be termed as critical forms. These forms capture critical data such as infusion, donor type and disease classification. If these forms are completed as close as possible to the actual infusion date, the subsequent forms triggered by critical forms will come due in a timelier manner. Forms completed in a timely manner will ensure specific study data, severe adverse infusion events and product complaints, as well as data for participating registries, cord blood banks, and apheresis/collection centers are more readily available for use.
|Critical Forms||Due Date|
|Indication for CRID Assignment (2814) Form||Due 30 days from registration|
|Pre-TED (2400) Form||Due 30 days from infusion|
|Pre-TED Disease Classification (2402) Form||Due 30 days from infusion|
|Hematopoietic Stem Cell Transplant (HCT) Infusion (2006) Form||Due 45 days from infusion|
Critical Forms Submission Requirements:
- Previous Trimester – Completion rate of 98% required to achieve CPI standard. Includes all forms that were due in the previous trimester.
- Current Trimester – Completion rate of 95% required to achieve CPI standard. Must be completed by DUE DATE noted in FN3 during the current trimester
NEW! Study Supplemental Forms
Participation in prospective studies is voluntary and requires a commitment from the Transplant Center Medical Director. If a center elects to participate in a study that requires additional (supplemental) forms to collect specific study data, CPI requirements will apply to these supplemental forms.
Study Supplemental Form Submission Requirements:
- 100% completion of study supplemental forms with DUE DATE in previous trimester (allows for an extra trimester to complete all study forms)
NEW! Query Resolution
Query placement process verifies that data used for studies, product quality assurance, Center Volumes Report (CVDR), Transplant Center Specific Analysis (TCSA) or for Consecutive Transplant Audit (CTA) are submitted accurately. Queries may be placed on missing or inconsistent data, or when clarification and/or documentation is needed to confirm the reported data. Query resolution should occur within six weeks after placement of the query.
Query Resolution Requirement:
- 95% completion of queries placed in the previous trimester
UPDATE! Non-Critical Form Completion Requirements
For all other forms not classified as critical or a study supplemental forms, CIBMTR monitors completion rates for two trimesters after the form’s due date.
Form Submission Requirement:
- 95% completion of all other forms due in previous trimester