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Patient Reported Outcomes (PRO) Protocol and Consent Forms

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Patient Reported Outcomes (PRO) Protocol and Consent Forms

The CIBMTR collects longitudinal or cross-sectional patient-reported outcomes (PRO) data from recipients of cellular therapies who are also enrolled in the Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries (Research Database protocol). The time points for PRO data collection will parallel the time points at which treatment centers submit clinical outcomes data from healthcare records, with an additional time point at 30 days post-treatment for cellular therapy patients.

Research Goals

The primary purpose of the PRO Protocol is to have a centralized collection of patient-reported symptoms and functioning to supplement traditional outcomes, such as survival or disease relapse, in registration and other studies. These data may be used in research to:

  • Assess trajectories of patient symptoms and functioning over time
  • Determine and evaluate symptoms and functioning that affect hematopoietic cell transplantation (HCT) and cellular therapy outcomes
  • Assess long-term outcomes after HCT or cellular therapy 

Recipient and Donor Participation

Any recipient of an unrelated or related HCT or cellular therapy in a CIBMTR-affiliated enter may participate in the PRO protocol. Complete eligibility requirements are outlined in the study protocol.

If the recipient of HCT or cellular therapy does not consent to the Research Database protocol, they may still participate in the PRO protocol, but the use of their data will be limited to CIBMTR and NMDP process improvement analyses or study-specific analysis as laid out in a customized consent form.

The CIBMTR Survey Research Group (SRG) identifies, approaches, and obtains consent from eligible recipients. Informed consent is documented in the CIBMTR electronic PRO (ePRO system). The SRG centrally collects PRO surveys from participating recipients electronically, on paper, or by phone and follows up with non-responders.

PRO data is collected in the ePRO system and then stored in the CIBMTR database where they can be linked to CIBMTR clinical outcomes data.

IRB Requirements

The PRO protocol is a single-site CIBMTR protocol. All research activities, including enrollment and data collection, are centrally performed within CIBMTR. Transplant centers do not need to submit PRO protocol or consent form to their local IRB. 

CIBMTR Approved Protocol and Consent Forms

The CIBMTR, through the NMDP/Be The Match IRB, has approved the following protocol and consent form. These are provided for reference only. Transplant centers should not submit these materials for local IRB approval. Transplant centers should not use these materials to consent recipients. 

PRO Protocol

PRO IRB Approvals

PRO Consent Forms

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    Last Updated: 2/11/2022 1:20 PM
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