Form Journey - Center for International Blood and Marrow ...
Transcript of Form Journey - Center for International Blood and Marrow ...
TRAINING & DEVELOPMENT | 1 .NEW DM ONBOARDING 2020 | 1 .
The CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between
the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW).
The CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between
the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW).
Form JourneyMatthew Klein, Stephanie Meyers, and Danielle Vitali
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Objectives
• Learn how to create a new CRID
• Become familiar with auto-population and how to update key
fields
• Understand the difference between form tracks (TED vs CRF)
• Practice various reporting scenarios
• Learn how to investigate reporting issues
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What is a CRID?
• CIBMTR Research ID = CRID
– Unique, lifelong identifier assigned when an individual is registered
with CIBMTR
– Individual may be receiving:
• Hematopoietic Stem Cell Transplant (HCT)
• Cellular Therapy (CT) (non-HCT)
• Treatment for marrow toxic injuries
• Non-cellular therapy (e.g., chemotherapy, immunotherapy, etc.)
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CRID Assignment Form (F2804)
• Collects information required to create the CRID– Certain data fields are used to ensure the same individual does not
inadvertently receive multiple CRID assignments
First Name /
Last Name
DOB /
Location of
Birth
Sex
Ethnicity /
Race /
Race Detail
Social
Security
Number
Mother’s
Maiden
Name
NMDP
Recipient ID
(RID)
IUBMID /
Team ID
Institution-
Specific
Subject ID
Outcomes
Registry
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CRID Assignment Form (F2804)
Do not include any identifying information in correspondence
with CIBMTR. Simply providing the CRID will allow us to access
all of the patient demographic information.
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Creating a CRID
• Before creating a new CRID, perform a search to ensure a
CRID does not already exist for your recipient at either your
center or another center.
– Follow the steps below to search for a duplicate CRID. Refer to
Document 1: Search CRID Job Aid.
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Activity: Duplicate CRID Search Our Recipient
First Name: Mary
Last Name: Poppins
DOB: 1/10/2001
Gender: Female
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Activity: Duplicate CRID Search • Login to the FormsNet3 external training environment
(https://formsnet3-extrn.nmdp.org/) using your unique login
information.
• Take 4 minutes to search for the recipient’s first and last name
– Refer to Document 1 for assistance with how to perform this
search.
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Activity: Duplicate CRID Search • Were you able to find a duplicate?
– If not, consider broadening your search.
• Try entering the gender and date of birth of the recipient
without the first or last name.
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Duplicate CRID Search
• Common data entry errors and inconsistencies can prevent
you from finding a duplicate from searching the name alone.
• Using other search criteria can increase your chance of
locating a possible match before a duplicate CRID is created.
You can then narrow your search after an initial broad search
(i.e. DOB and gender).
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Duplicate CRID Search
• Since this recipient is from our center, we can verify (despite the
spelling error) this is the same recipient.
• When you encounter a case like this, navigate to the edit icon,
and update the appropriate information (last name spelling,
removing middle name).
Please DO NOT edit this for our search.
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Creating a CRID
New recipients, that were not seen to have a duplicate CRID,
need to be registered on the CRID Assignment Form (F2804)
in FN3.
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Activity: Creating a CRID (F2804)
• Create a CRID of your own for this form journey and take 5
minutes to complete in the external training environment.
• Refer to Document 2: Sample Recipient EMR in the
recipient materials located in your folder.
• The name, gender and mother's maiden name of your
recipient will be created by you. Feel free to be creative while
creating a recipient name.
• Fields such as SSN and other information are NOT provided
in Document 2 and can be left blank.
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Indication for CRID Assignment (F2814)
• The F2814 is used to specify whether the individual will be
receiving Hematopoietic Cellular Transplant (HCT), cellular
therapy (non-HCT), marrow toxic injury therapy, or non-cellular
therapy.
• This form will come due upon the completion of the F2804.
2804 2814
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Indication for CRID Assignment (F2814)
Indication for
CRID
Assignment
includes:
HCT Cellular
Therapy
Marrow Toxic
Injury
Non-Cellular
Therapy
Source:
Auto,
Allo_R,
Allo_U
Planned
HCT Date
Planned
CT DateEvent
Date
Disease/
Study for
Non-CT
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Indication for CRID Assignment (F2814)
• Once a CRID as been registered, the Indication F2814 must be
completed
• Subsequent infusions of the same indication DO NOT require
an additional F2814.
– A subsequent infusion with a new indication may require completion of
another F2814 (See Document 3: Reporting CT Infusions Memo
for an example).
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Activity : Complete the Indication Form (F2814)
• Take a 4 minutes to complete for your recipient.
• Again, refer to Document 2: Sample Recipient EMR
Remember: This patient received an HCT, so not all
questions on this form are required to be answered.
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From the F2814 to the Pre-TED Forms
HCT
F2400 and F2402
Cell Therapy
F4000
After completing the F2814 you may be asked to complete: - Pre-TED Forms 2400 and 2402 for HCTs
- CT Pre-Infusion Form 4000 for CTs
For our journey examples, we will be reporting HCTs.
2804
2814
2400 /
2402
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Pre-TED (F2400)
• The Pre-TED is required for every Allogeneic HCT, as well as
for every Autologous HCT performed at CIBMTR centers who
choose to report on AUTOS.
• The Pre-TED may be submitted to CIBMTR up to two weeks
prior to the start of the recipient’s preparative regimen,
however it may be best to complete this after the transplant
has occurred in case it is cancelled or delayed.
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Pre-TED (F2400)
The Pre-TED captures a variety of important Pre-HCT information,
including:
Recipient
Demographic
Data Consent
HCT
Information Donor
Information
Clinical
Status of
Recipient
Comorbid
Conditions
Preparative
Regimen
Peri-
Transplant
Period
Treatment
GVHD
Prophylaxis
Post-HCT
Disease
Therapy
Planned as
of Day 0
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Activity : Completing the Pre-TED (F2400)• Refer to Document 2: Sample Recipient EMR
and Document 4: HCT-CI(comorbidity index) Chart
• Use these documents to complete the f2400
• Take 10 minutes to complete.
• REMINDERS FOR THIS TRAINING:
– Any questions you do not have documentation on, report ‘unknown’.
– Certain fields such as date of birth, gender, ethnicity, race, race
detail and NMDP RID will auto populate from the F2804.
– NOTE: This is a mock F2400 for training purposes only and is NOT
representation of real-world reporting practices.
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Pre- TED Disease Classification (F2402)
• The second part of the Pre-TED forms is the Disease
Classification Form.
– This form captures important details regarding the recipient’s primary
disease for HCT.
• It is required for all transplants, including subsequent
transplants for the same disease.
2804 2814
2400
2402
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Pre-TED Disease Classification (2402)
Report the primary disease for
HCT and the date of diagnosis
in questions 1-2.
ALL(96-163)
ALAL
(164-167)
AML(3-95)
CML(168-178)
MDS(179-258)
MPN(259-371)
Other
Leukemia(372-378)
HL/NHL(379-396)
PCD
(397-443)
You will then be directed to the proper disease section of the F2402.
AND MORE …
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Activity: Completion of the F2402
• Refer to Document 5: Training Lymphoma 2402 Status in
your binder pertaining to your training recipient and use these
materials to complete the F2402 .
• Take 6 minutes to complete.
• REMINDERS FOR THIS TRAINING:
– Any questions you do not have documentation on, report ‘unknown’.
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Follow-Up Form Track: TED vs CRF
• After completing the Pre-TED forms, you will be
assigned to either the TED (Transplant Essential Data)
or the CRF (Comprehensive Report Forms) track based
on CIBMTR’s selection algorithm.
– NOTE: the algorithm will run every time these forms are
reprocessed.
• Regardless of the track you are on, data will be
collected at the 100d, 6m, 1y, 2y, 3y, 4y, 5y, 6y, and
then every 2 years.
F2400
F2402
F2450
F2400, F2402,
F2000, F2100,
F20xx (inserts),
F21xx( inserts),
F2900
TED
CRF
2804 2814
2400
2402
TED
CRF
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Follow-Up Form Track: TED vs CRF
Notice the difference between the tracks?
With the TED track, there is only one form per reporting period, and with
the CRF there are 5 in the 100D period in this case.
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Post-TED Follow-Up (F2450)
Captures the following information:
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Post-HCT CRF Follow-Up Form (F2100)
Captures the following additional information:
Immune
reconstitution
Immune
Reconstitution
Current
Hematologic
Findings
Engraftment
Syndrome
Infection
ProphylaxisInfection
Organ
Function
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CRF Disease Inserts
Along with F2000 and F2100, CRIDs on the CRF track will
usually have disease-specific inserts for each reporting period.
2804 28142400
2402
F2000
F2100
F20xx (inserts)
F21xx( inserts)
2010 / 2110 : AML
2011 / 2111 : ALL
2012 / 2112 : CML
2013 / 2113 : CLL
2014 / 2114 : MDS
2015 / 2115 : JMML
2016 / 2116 : PCD
2018 / 2118 : HL / NHL
2019 / 2119 : WM
2024 / 2124 : SAR
2028 / 2128 : APL
2031 / 2131 : ID
2033 / 2133 : WAS
2034 / 2134 : XLP
2039 / 2139 : HLH
2057 / 2157 : MPN
AND MORE…
TRAINING & DEVELOPMENT | 30 .NEW DM ONBOARDING 2020 | 30 .
CRF Disease Inserts
Disease
Assessment
at Diagnosis
Lab
Assessment
at Diagnosis
Pre-HCT
Therapy
Lab Studies
Last Eval
prior to Prep
Disease
Status Last
Eval prior to
Prep
Disease
Specificity
2016
2116
Disease
Assessment
at Time of
Best
Response
Post-HT
Therapy
Disease
Status at
Time of Eval
2016 vs 2116 (PCD Example)
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Activity: What Track Is Your CRID On? • Now that we have completed our F2804, F2814, F2400 and
F2402, your recipient has been assigned to a reporting track
(TED or CRF).
• Can you tell which track your recipient is assigned?
– TED track CRIDs should only have F2450s follow-up forms.
– CRF track CRIDs should have the F2000, F2018 (HL / NHL), F2100,
and F2118 (HL / NHL).
• How many people are on the CRF track?
– On average, about 25% of CRIDs created will go to the CRF track. (Some centers may have more or less than this for a number of reasons including study
participation, consent rates, CRF center status etc.)
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Forms 2004 / 2005 / 2006
• Forms 2004 (Infectious Disease Markers), 2005 (HLA-typing)
and 2006 (Infusion) may be generated based on the answers
reported on the Pre-TED F2400.
– These forms may come due for both CRF and TED level reporting
tracks.
• Reporting guidelines can be found in the How Forms Come Due
tables of the Data Management Guide.
2804 2814
2400
2402
2004
2005
2006
TRAINING & DEVELOPMENT | 33 .NEW DM ONBOARDING 2020 | 33 .
Activity: F2004 / 2005 / 2006
• Refer to Document 6: How Forms Come Due (Scenario
One)
– Utilize the How Forms Come Due tables in the Data Management
Guide and Document 7: How Forms Come Due Job Aid to assist
with this scenario.
• Take 5 minutes to review the scenario and determine if the
F2004, F2005 or F2006 should come due given the
information provided.
• Remember the key mentioned earlier.
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F2804 and Auto-Population
• The F2804 is not present in the Forms Grid on the main
recipient page.
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F2804 and Auto-Population Continued
• To access the F2804 in FN3, refer to the Search / Edit CRID
Job Aid (Document 1).
• Several categories such as ethnicity, race, date of birth and
NMDP RID are auto-populated on the F2400 from the F2804.
– The only way to update the auto-populated questions on the F2400
is to update the F2804 and then reprocess (re-submit) the F2400.
You do this by clicking the arrow on the form as seen below.
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Activity: Updating Auto-Populated Fields
• We have discovered that the DOB reported on your training
recipient should be 04-28-1976.
• Refer to Document 1: Search / Edit CRID Job Aid for steps
on how to edit a previously created CRID.
• Take 4 minutes to update the date of birth on the F2804 and
reprocess the F2400.
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Consent
When a recipient receives a transplant at a CIBMTR center, we
expect the recipient to be approached for the Research database
consent. Please see Document 8: Database consent for an
example.
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Consent Considerations• If the recipient DOES NOT consent to submit data for research:
– AUTO Transplants will only require Pre-TED forms to be completed.
– ALLO Transplants will be assigned to the TED track and required to
complete only the Pre-TED and Post-TED forms (with the exception of
study participants).
– See Document 9: New Pre-TED Requirement Memo and
Document 10: Completion of pre-TED for all patientsALLO
AUTO
TRAINING & DEVELOPMENT | 39 .NEW DM ONBOARDING 2020 | 39 .
Consent Considerations (AUTO No-Consent)For a subsequent transplant, usually you report the subsequent transplant on a
Post-HCT follow-up form (F2450 or F2100).
• In the case where there was NO consent given for the first AUTO transplant, F2450 and F2100
do not come DUE, so there are no forms to report the subsequent transplant on.
– In this case, contact the CIBMTR Center Support to request new Pre-TEDS be added for the
subsequent transplant. Be sure to include: HCT date, HCT type (Allo_U, Allo_R, Auto), and product
type (BM, PBSC, CBU).
“This recipient had a second auto transplant, but has not signed a CIBMTR consent. Is it
possible to add the F2400 & F2402, so the infusion can be reported?”
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Activity: Follow-Up Forms
• Take 4 minutes to review CRID 3913417 in the external
training environment in “Read Only” mode.
• What forms are currently due for this recipient and why?
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Follow-Up Form Track Change
• Sometimes a recipient’s CRID will change tracks (from TED
to CRF or vice versa).
- This can happen for any number of reasons including:
• Reprocessing the F2400 to make an update to the form or resolving a
query (makes the algorithm run again).
• CIBMTR updates the track due to enrollment in a study.
• CRID has a subsequent transplant assigned to a new track.
TRAINING & DEVELOPMENT | 42 .NEW DM ONBOARDING 2020 | 42 .
Follow-Up Form Track Change
• Contact the CIBMTR Center Support if you feel a CRID’s
track has changed in error.
“Good afternoon! I was fixing an error on the F2400. When submitting the corrections, a
bunch of new forms populated. We already completed the F2450 100 day and now new
F2100/2118 forms populated. Was this a glitch in the system? If possible, please return the
CRID to the TED track. Thank you!”
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Survival Status: Patient Death (TED Track)
Report recipient’s death on F2450 by using the date of death to answer ‘date of
actual contact’. All remaining F2450 forms for subsequent reporting periods will
be automatically removed.
– Death on F2450 can be reported and NO F2900 will come due.
**All forms should be in complete status and
no remaining forms ‘DUE’ after reporting
recipient death.**
2020 01 27F2450
TRAINING & DEVELOPMENT | 44 .NEW DM ONBOARDING 2020 | 44 .
Survival Status: Patient Death (CRF Track) Recipient’s death needs to be reported on BOTH the F2100 and the F2900.
• Report recipient’s death on F2100 by using the date of death to answer ‘date of
actual contact’.
– This will create a F2900 once the F2100 is in CMP status.
• Report recipient’s death on the F2900.
• Once date of death is reported and matches on both completed forms,
subsequent due follow-up forms will be automatically removed
2020 01 27
2020 01 27
F2100
F2900
TRAINING & DEVELOPMENT | 45 .NEW DM ONBOARDING 2020 | 45 .
Activity: Death Reported
• Review the 100D form(s) for CRID 3913003 in ‘Read Only’
mode.
• Take 4 minutes to determine WHY forms are continuing to
come DUE even though death has been reported on the 100d
f2100 and the death form f2900 . (Note : some forms may be
on different pages in FN3)
• Can anyone think of why this is?
• What steps could we take to solve this issue?
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Lost to Follow-Up (LTF) and Survival (SUR)
The Lost to Follow-up
Declaration should be
submitted when the transplant
center is unable to establish
ANY contact with the recipient.
• The transplant center should
continue attempt to establish
contact in the subsequent
reporting periods after making the
previous reporting period LTF.
TRAINING & DEVELOPMENT | 47 .NEW DM ONBOARDING 2020 | 47 .
Lost to Follow-Up (LTF) and Survival (SUR)
The Survival Status is to be used when you know the recipient is
alive, however ALL efforts to obtain follow-up data on the recipient
have failed.
• In this case, report the recipient’s known survival date.
TRAINING & DEVELOPMENT | 48 .NEW DM ONBOARDING 2020 | 48 .
Lost to Follow-Up (LTF) and Survival (SUR)
• To change form status to lost to follow-up or survival, select
the Lost to Follow-up icon below
• The icon only displays for eligible forms and only if the form is
in DUE status
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Lost to Follow-Up (LTF) and Survival (SUR)
• LTF status means there is NO contact with the recipient
during the entire reporting period.
• SUR status means there HAS BEEN contact to establish
survival, but does not yield any follow-up data (Example:
phone calls, influenza vaccine, etc).
• If you need a form changed from LTF or SUR back to ‘DUE'
after obtaining new information, contact the Center Support
team (CSC).
NOTE: Neither option is available on the 100D forms. As long as the
recipient received an infusion, there is data to report during the
reporting period.
TRAINING & DEVELOPMENT | 50 .NEW DM ONBOARDING 2020 | 50 .
Activity: Lost to Follow-Up (LTF) & Survival (SUR)
• Return to the forms grid for your training recipient and make
the 6M form LTF and the 1Y form SUR.
• Take 4 minutes to practice changing the status of these
forms.
• Please click on the following icon to report these statuses
• After completing this task, what happens if you found
new information?
• How would you update the form status back to 'due' from
LTF or SUR ?
TRAINING & DEVELOPMENT | 51 .NEW DM ONBOARDING 2020 | 51 .
Form Change History
• If you would like to check the history of a form and how
certain questions on each form were answered, use the form
change history tool.
– The icon for this tool will appear as a clock with a green arrow on it.
• See the example below. For each date, an update was made
to this form. Click on the arrows to see WHAT and WHEN
specific changes were made.
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Transfers
• One of the most complicated scenarios we come across is
transferring a CRID from once center to another.
• Let's review several transfer scenarios we may encounter.
TRAINING & DEVELOPMENT | 53 .NEW DM ONBOARDING 2020 | 53 .
Transfer Form (F2801)
• When a CRID needs to be transferred from one center to
another, complete the F2801. A center can request the
contact information of the other center’s data manager to work
together to complete the form.
• Once completed, either data manager may submit the form to
the CIBMTR Center Support for processing.
TRAINING & DEVELOPMENT | 54 .NEW DM ONBOARDING 2020 | 54 .
Transfer Form (F2801)
• Refer to Document 11: Transfer Form (F2801) Guide and
Document 12: Transfer form for tips on completing the
form.
• If this is a duplicate CRID, request the CRIDs to be merged
FIRST, and keep the original (oldest) CRID.
– The original CRID should be the CRID entered on F2801.
• The original center will still be able to view the forms they
completed, and the receiving center can view the forms the
original center completed but cannot edit them.
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Transfers: Earliest Complete Date
• The date the completed F2801 is received by CIBMTR is
considered the effective date of the transfer.
– Any forms with an earliest complete date prior to the effective date
will remain DUE at the transferring FROM center.
– Any forms with an earliest complete date after the effective date will
become DUE at the transferring TO center.
TRAINING & DEVELOPMENT | 56 .NEW DM ONBOARDING 2020 | 56 .
Transfer Form (2801)
• If a subsequent HCT has occurred, this will need to be
reported on the appropriate follow-up form in order to
generate the new event forms.
– Discuss which center will be reporting the subsequent HCT prior to
submitting the F2801.
• If the recipient transferred their care to a new center but has
not received a subsequent HCT there, the recipient must
consent at the transferring TO center before the F2801 is
submitted.
TRAINING & DEVELOPMENT | 57 .NEW DM ONBOARDING 2020 | 57 .
Transfers : CAR-T Scenarios
• Center A performs HCT and Center B performs CAR-T
– If Center B is reporting the CAR-T infusion to CIBMTR, a transfer is
required to move the reporting responsibility (both HCT and CT) to
Center B.
– If Center B is not reporting CAR-T infusions to CIBMTR, Center A
should still report the CAR-T infusion on the appropriate HCT follow-
up form, and request through CIBMTR Center Support that the
CTED F4000 be made NRQ. A transfer is not required.
• Center A performs CAR-T and Center B performs HCT
– Center B should request a transfer and will be responsible for the
CAR-T follow up forms.
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TRAINING & DEVELOPMENT | 58 .NEW DM ONBOARDING 2020 | 58 .
Universal / Combined Follow-up
• Implemented a new “Hard Stop” solution that allows both HCT
and CT forms to be collected for a subsequent infusions
without duplicate reporting.
• Released July 24th, 2020
• All diagrams can be found here: https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/subsequent-infusions-
updates-to-follow-up-reporting
TRAINING & DEVELOPMENT | 59 .NEW DM ONBOARDING 2020 | 59 .
QUESTIONS?
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