BMT CTN 1704 CRF Completion Guidelines (CCGs)

Topics included in this manual:
Demographics Form
Inclusion / Exclusion
Healthcare Team Assessment
Frailty Assessment
Montreal Cognitive Assessment
Conditioning and Transplant Dates
Serious Adverse Event Assessment
Adverse Event Summary
Adverse Event Medications
Adverse Event Laboratory Values
Adverse Event Tests
Study Exit
Protocol Deviation
Re-Consent
UPIRSO Assessment

Manual Updates:
Sections of the BMT CTN 1704 CRF Completion Guidelines (CCGs) may occasionally be updated. In addition to documenting the changes within each manual section, a summary of the most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

Date	Manual Section	Add/Remove/Modify	Description
04/10/2020	All Sections	Modify	Version control updated to CCG v.4.0 and CRF v.3.0
05/13/2020	Serious Adverse Event (SAE) Assessment	Modify	Moved instructions into an information banner
05/13/2020	Conditioning and Transplant Dates	Add	Added Donor Type and corresponding instructions to the Conditioning and Transplant form
05/13/2020	Conditioning and Transplant Dates	Add	Added Product Type and corresponding instructions to the Conditioning and Transplant Dates form
05/13/2020	Conditioning and Transplant Dates	Add	Added Primary disease for which the HCT was performed question and corresponding instructions to the Conditioning and Transplant Dates form
05/13/2020	Conditioning and Transplant Dates	Add	Added additional instructions for CIBMTR Research ID
05/13/2020	Montreal Cognitive Assessment (MoCA)	Add	Added visit type to the Montreal Cognitive Assessment (MoCA)
05/13/2020	Frailty Assessment	Add	Added visit type to the Frailty Assessment form
05/13/2020	Frailty Assessment	Modify	Updated the Submission Time Frame to ‘At baseline, form should be submitted within 30 days of transplant. At follow-up time points, form should be submitted within 30 days of assessment completion.’ instead of ‘within 30 days of evaluation date for study time point.’
05/13/2020	Healthcare Team Assessment	Modify	Updated Submission Time Frame to be within 30 days of transplant date instead of within 30 days of evaluation date
05/13/2020	Inclusion/Exclusion	Add	Added future planned transplant date question to Inclusion/Exclusion
05/13/2020	Inclusion/Exclusion	Add	Added future planned conditioning start date question to Inclusion/Exclusion
05/13/2020	Demographics	Add	Added additional instructions for Subject ID within the System Generated Answers
05/13/2020	Demographics	Add	Added Race as a subsection of the Demographics form
05/13/2020	Demographics	Add	Added Ethnicity as a subsection of Demographics form
04/10/2020	All Sections	Modify	Version control updated to CCG v.3.1 and CRF v.2.1
04/10/2020	Study Exit	Add	Added COVID-19 as a reason for a subject-related protocol deviation
04/10/2020	Study Exit	Add	Added COVID-19 as a reason for a site-related protocol deviation
04/10/2020	Study Exit	Add	Added COVID-19 as a reason protocol deviation occurred
04/10/2020	Study Exit	Add	Added COVID-19 as a reason subject did not proceed to transplant
04/10/2020	Study Exit	Add	Added COVID-19 as a reason subject exited prior to study completion
04/10/2020	Study Exit	Add	Added instructions regarding COVID-19 as a reason for study exit
04/10/2020	Conditioning and Transplant Dates	Add	Added note regarding infusion date
04/10/2020	Conditioning and Transplant Dates	Remove	Removed unnecessary transplant date instructions
04/10/2020	Conditioning and Transplant Dates	Modify	Updated the submission time frame to be within 30 days after the date of transplant
04/10/2020	Frailty Assessment	Add	Added additional instructions to the walking test measurements
04/10/2020	Healthcare Team Assessment	Modify	Updated the time frame from 21 days to 14 days that the C-Reactive Protein Test should be collected
04/10/2020	Healthcare Team Assessment	Add	Added additional instructions to C-Reactive Protein test
02/04/2020	All Sections	Modify	Version control updated to CCG v.3 and CRF v.2
02/04/2020	Frailty Assessment	Modify	Manual formatting correction
02/04/2020	Frailty Assessment	Add	Added additional instructions for weight 1 year ago
02/04/2020	Frailty Assessment	Modify	Manual formatting correction
02/04/2020	Healthcare Team Assessment	Add	Added Baseline PRO Survey section
02/04/2020	Inclusion / Exclusion	Modify	Manual formatting correction
12/18/2019	BMT CTN 1704 CRF Completion Guidelines	Modify	Version 2 of the BMT CTN 1704 CRF Completion Guidelines (CCGs) released. Version 2 corresponds to version 1.2 of the Case Report Forms.

Version Control Table
Date Of Release	CRF Version	CCG Version
05/13/2020	4.0	3.0
04/14/2020	3.1	2.1

CCG v.4.0 | CRF v.3.0

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.