Header Definitions

5d - Header Definitions_to HRSA 2022-03-29.pdf

Stem Cell Therapeutic Outcomes Database

Header Definitions

OMB: 0915-0310

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Information Collection Domains
Indicates the category of information collection by time period that corresponds to the burden table. For each of the following Domains, there is a
corresponding Tab.
1- Pre-Transplant Information Collection
2- Transplant Procedure and Product Information
3- Post-Transplant Periodic Information Collection
Below are the defintions for each column heading.

Column Header Title

Column Header Title Definitions

Identifies a grouping of information collection within an Information Collection Domain. These information collection domain sub types roughly correspond to
section/domain headers currently found on CIBMTR data collection instruments.
Information Collection Domain Additional Sub Domain
Additional Sub Domain set recipeint, donor, infusion type or product criteria that must be met for an information collection element to be required
Response options are "yes" or "no".
Response required if Additional Sub Domain applies
If the criteria noted in Additional sub domain applies, the information collection data element will be applicable and information collection data element
responses supplied. Always "yes" when an additional sub domain is present.
Information Collection may be requested at multiple times Response options are "yes" or "no".
Some information may be collected at "multiple" time points or in multiple iterations. A multiple request may occur with a new or duplicate event, new
infusion, changes in treatment or outcomes follow up. For example: product analyses at multple timepoints, chimerism analyses on multple dates,
subsequent neoplasms, co-morbidities, covid infection, Disease Status, Post Transplant Therapy, GVHD, labs and pathology (collected at diagnosis, between
diagnosis and infusion, at infusion and during followup)
Current Information Collection Data Element (if applicable) Depicts the information collection data element currently being requested.
Information Collection Domain Sub-Type

Current Information Collection Data Element Response
Option(s)
Information Collection update:

Proposed Information Collection Data Element (if
applicable)
Proposed Information Collection Data Element Response
Option(s)
Rationale for Information Collection Update

Depicts the information collection data element response options currently being requested.
Notes the type of update. If Blank, there was no change.
options:
Addition of Information Requested
Deletion of Information Requested
Deletion of Information: Merged to Check all that Apply
Change/Clarification of Information Requested
Change/Clarification of Response Options
Change/Clarification of Information Requested and Response Options
Depicts the changes to the information collection data element requested in red line format. Rows containing changes are highlighted in Yellow
Depicts the changes to the information collection data element response options in red line format. Rows containing changes are highlighted in yellow.
The following options identify the change summary:

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Header Definitions

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Column Header Title

Column Header Title Definitions
options:
Reduce burden: expanded response options to include responses previously reported manually or created a "check all that apply"
Be consistent with current clinical landscape, improve transplant outcome data
Capture data accurately
Examples added or typographical errors corrected for clarification
Covid-19 Impact
Capture additional relevent disease information

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Header Definitions

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File Typeapplication/pdf
File TitleSCTOD Information Collection_to HRSA 2022-03-29.xlsx
Authordoleysh
File Modified2022-03-29
File Created2022-03-29

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