The auditors compare recipient data entered into FormsNet with data in the recipient medical record and other appropriate source documents (e.g., HSC processing records). If a discrepancy is found between the data reported to the CIBMTR and the source document, the auditors correct the originally reported data. The auditors categorize the discrepant data into one of three groups: audit errors, missing documentation errors, and non-audit changes.
Not all fields on the form will be audited. Two types of fields are selected for audit: critical fields and random fields.
- Critical fields are those data fields that have been identified as being essential to the accurate completion of outcomes analyses. These fields will be audited for each recipient, though may differ based on disease and transplant type.
- Random fields are additional data fields added to the audit to increase the validity of the audit. The random fields may differ between recipients.
- Audit errors are assigned when data in the medical record differs from what was reported or data found in the medical record was not reported. Auditors make all data corrections in the Research Database, and the transplant center is provided with a record of each change made to forms.
- Missing documentation errors are assigned when data cannot be verified by a source document at the time of audit. Attempts are made during and post-audit to acquire the missing documentation. For more information, see Missing Documentation Follow-up section below.
- Non-audit changes do not count towards audit error rates. Fields not selected for audit may be reviewed and updated as necessary. Changes made to these types of fields will be classified as “non-audit changes.” Non-audit changes may also be made in critical or random fields for situations where it is not appropriate to assign audit or missing documentation errors.
In addition to auditing CIBMTR forms, consent forms are audited for proper completion. The consent forms audited are dependent on the type of transplant. For additional information about Consent Forms, review information located in the Protocols and Consents section of the CIBMTR website.
When reviewing the consent forms, the following criteria are used:
- All pages of the consent form are present.
- The consent form has been signed and dated by the recipient (or parent/guardian).
- The sample repository consent form has been signed prior to the collection of blood sample and the research database consent form has been signed prior to the submission of data.
- The consent form was signed within the IRB approval period. If the date range is not on the consent form itself, accompanying IRB correspondence is reviewed.
- All blanks on the consent form are completed. This includes any space designated for MRN numbers, printed names, health care provider signatures and dates, checkboxes, initials, witness lines (if applicable), etc.
If any issues are found on a recipient’s consent form, corrective action is necessary to address each issue.