DATA COLLECTION FORMS

CIBMTR data collection and management activities are fully integrated across both CIBMTR campuses. A harmonized set of TED forms and CRFs, released in December 2007, is used for collecting all HCT data. All data collection forms can be viewed and downloaded at the CIBMTR website (http://www.cibmtr.org/DataManagement/DataCollectionForms).

11.5.1 Forms Development and Revision

The CIBMTR plans to conduct forms revisions on a regular basis in response to rapidly changing technologies (e.g., molecular markers, cytogenetic prognostic factors, etc.) and internationally accepted criteria updates for disease response. The process is comprehensive involving many internal and external individuals and three levels of review. The first level involves scrutiny of data field details by subject matter experts, MS-level Statisticians, volunteer Working

Committee members, Transplant Center Data Managers and a CIBMTR Metadata Analyst who assures consistency across all forms. CIBMTR Scientific Directors, Working Committee members and IT staff then review from a scientific and logistical standpoint. The review concludes with assessment by CIBMTR Data Operations leadership. Forms are released into production on a date mutually agreed upon by CIBMTR Data Operations and IT staff.

11.5.2 Forms Training

Forms training is conducted in many venues including a Clinical Research Professionals Data Management conference held at the BMT Tandem Meetings in February. Conference materials, including audio recordings from selected sessions are available at the CIBMTR website

(http://www.cibmtr.org/Meetings/Materials/CRPDMC).

The CIBMTR Data Management Manual (http://www.cibmtr.org/DataManagement/Training

Reference/Manuals/DataManagement) provides detailed information about forms completion including SCTOD reporting requirements, protocols and the consent process, and instruction manuals for the Pre-TED (2400), Post-TED (2450), CRF forms (2100, 2200, 2300) and some diseases including acute myelogenous leukemia, multiple myeloma and non-Hodgkin

lymphoma. CIBMTR liaisons help address issues and answer questions that may not be covered in the Data Management Manual.

The CIBMTR also provides a Center Reference Guide (http://www.cibmtr.org/Data

CIBMTR Manual of Operations Chapter 11: Data Management

research, center membership, data submission, data manager education, mentor program, forms submission process, and many useful tips and links.

11.5.3 Forms Submission

FormsNet allows transplant centers to electronically submit data to the CIBMTR using both TED forms and CRFs. It includes real-time error validation, override capabilities, and access to the Forms Due Report. Periodic FormsNet updates are released to address revisions and

enhancements. FormsNet also includes:

 SecurIDTM _{System: This feature enhances FormsNet security by requiring a second} identity authentication. The transplant center’s primary contact is authorized to set up new users and request new or replacement SecurID cards online through the CIBMTR

website (http://www.cibmtr.org/DataManagement/AdminResources/Personnel). When

the request is complete, the primary contact then activates the new user in FormsNet (under the maintenance tab).

 Override Codes: Override codes allow users to force entry of data fields that are flagged

as errors in FormsNet. Errors should be assigned an override code only if the data field is confirmed as correct by transplant center staff (e.g., data manager) by comparing the data field with the appropriate source document. The CIBMTR monitors each transplant center’s use of override codes.

Although transplant centers are strongly encouraged to submit data via FormsNet, they can also submit paper forms, which can be downloaded and printed from the CIBMTR website (http://www.cibmtr.org/DataManagement/DataCollectionForms/Pages/index.aspx) and then faxed or mailed (Postal or Fed-Ex) to the Minneapolis Coordinating Center. Upon receipt, data collection forms undergo a review for completeness and are entered into FormsNet by CIBMTR staff. Any validation errors detected by FormsNet can be corrected by the center directly through FormsNet, or Error Correction Forms can be obtained and submitted in the same manner as all other Report Forms. Electronic copies of all paper data collection forms and attached documents are imaged for future reference, and the original documents are destroyed using a secure process.

AGNIS, which was created by the CIBMTR and NMDP/Be The Match Bioinformatics, also

supports secure, electronic data sharing across diverse database systems and assists transplant centers in collecting data for internal research, patient care requirements, and reporting purposes. For more information, see the CIBMTR website (http://www.cibmtr.org/ DataManagement/TrainingReference/AGNIS) and Chapter 14.

11.5.4 Forms Reimbursement

The CIBMTR reimburses transplant centers for all completed CRFs through funds that support the Research Database. Reporting of TED-level data is not reimbursed, with the exception of Infusion (Form 2006) for NMDP/Be The Match or related recipients. When a form is designated as accurate and complete in FormsNet, the transplant center is reimbursed according to a fee schedule, which is posted on the CIBMTR website (http://www.cibmtr.org/DataManagement/ AdminResources/Fees).

The CIBMTR cannot reimburse for CRFs until it has a current, signed Data Transmission

transfer patient data to the CIBMTR for use in its research. This is in addition to the center’s IRB approval for the CIBMTR research protocol and associated consent forms. Data Transmission Agreements are submitted to the NMDP/Be The Match Contracts department designees, who are assigned to specific centers. CIBMTR liaisons also help with forms reimbursement questions and issues.