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Frequently Asked Questions
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Consent
Should I continue to submit data for patients who were transplanted prior to
December 3, 2007 but from whom consent for research was never obtained?
You may continue to submit data on autologous and allogeneic related recipients
who did not provide research consent as long as your center submitted data on
these cases prior to December 3, 2007 and your center had a Data Use Agreement in
place with CIBMTR at the time data submission was initiated for these patients. The
NMDP did not have Data Use Agreements with transplant centers, so all unrelated
recipients transplanted before December 3, 2007 must have provided research
consent if you are going to submit their data to the CIBMTR.
Why does the autologous consent for the research database have a section
where the social security number, mother’s maiden name and birth city for
registration purposes but the allogeneic consent does not ask for this
information?
The Stem Cell Therapeutic and Research Act of 2005 mandates that all allogeneic
related and unrelated transplant recipients must be registered in the Stem Cell
Therapeutics Outcomes Database (SCTOD). Autologous transplant recipients are not
included in this legislation and registration in the SCTOD is therefore voluntary.
Because registration is voluntary for autologous transplant recipients, centers are
asked to provide consent for the different data elements that are used to register a
recipient and create a unique identification number. These include, date of birth,
place of birth, gender, social security number and mother’s maiden name. Allogeneic
related and unrelated recipients are not given a choice about being registered in the
SCTOD because it required by the federal government. They are, however, asked to
provide consent if they are willing to allow their data to be used in CIBMTR research
studies.
Do you need all the identifiers to create a CRID (CIBMTR Recipient
Identification Number) for the autologous recipients? Can we just provide
their social security number?
None of the identifying information is used to actually create a CRID. The identifying
information is only used to determine if the recipient is already registered and
prevent the same recipient from having multiple CRIDs in the system. The more
identifying information that is provided, the higher the level of confidence that the
recipient has not been previously registered. The Social Security Number (SSN) by
itself ensures that a recipient is not registered twice in the system as this is
completely unique to each individual.
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Do we have to complete forms for autologous patients who do not sign
consent?
No. If an autologous patient declines to participate in research, the only information
that CIBMTR asks that you submit is the Unique ID Assignment form to obtain a
CRID. This form asks for transplant type, date, and disease. The data provided on
this form is used to ensure that no bias is introduced into CIBMTR studies on the
basis of cases that are not being reported. These data are also used to report
transplant center volumes on the .gov website if your center chooses to include
autologous transplants in the center volumes report. If these patients have a
subsequent transplant, notify your liaison of the date and type of that transplant so
that he or she can update the patient’s record in FormsNet.
Forms Submission
We just received a follow-up request from a cord blood bank, but we’ve
submitted the data to CIBMTR. Do we have to submit it again?
No. If you are getting follow-up requests for cases that you’ve registered in
FormsNet2, send the CRID and the follow-up request to Jenni Bloomquist
(jbloomqu@nmdp.org) to determine what the next step may be. Note that nonNMDP legacy (prior to 12/3/07) cases cannot be sent to the banks on your behalf. If
you’ve completed follow-up forms in FormsNet2, you can print them and forward
them to the requestor if you wish.
There are forms on my list that I wasn’t expecting. What should I do?
Because CIBMTR developers are working daily to resolve issues that have been
reported on the Forms Due Report, you may notice that the forms due for a
particular patient changed from the last time you viewed the list. Before contacting
your liaison, determine whether it makes sense that the form is due. For instance, if
you reported that the patient had a fungal infection, a Fungal Infection Supplement
(2046, 2146) may have come due. If you know that the forms are incorrect, contact
your liaison to report the problem if you have not done so already.
We have a patient assigned to the TED follow-up track that received two
products, but only 1 Infusion Form (2006) came due. Is that right?
Infusion forms are due for NMDP products and Cord blood products regardless of
the track assignment or research consent. If you infused multiple products and were
assigned to the TED track, you will only get Infusion forms for the NMDP products
and the cord blood products. Contact your liaison with further questions on this.
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I have completed and sent some paper forms to the CIBMTR for data entry that
are still listed on the Forms Due Report. Why are they still showing due?
The paper form was either not received or it could not to be keyed into FormsNet.
Several situations could cause a form to not be entered. In these cases, the center is
notified of the incomplete form. If there was an error in an essential field on the
form that would not allow the form to be entered, the form will continue to be listed
on the Forms Due Report. You would have been sent an error correction when
CIBMTR discovered the error. If you are concerned you may not have gotten this
message, contact your liaison to check. Essential fields where errors prevent data
entry include problems with HSCT date, CRID, Visit ID, Form number, Missing
Today’s date, product type, HSCT Type.
If the form has been keyed but there are errors that have not been resolved, the
form will remain on the list and the status will be QRY until all errors have been
addressed by the center.
These lists are huge! Where do I start?
While each center will have a different set of issues, below are a few
recommendations to try to prioritize the work: Do a search for all Pre-TEDs (Form
2400) using Center Forms Due. Until the Pre-TED forms are complete, the patient
cannot be run through the selection algorithm to determine what follow-up forms
will be due. For any patients that you know have died that have not yet been
reported as deceased, complete the death information (either on the TED form or on
the CRF Form and the Death Report) so that the extra forms will drop from the list.
It helps to shorten the lists to make them more manageable. If you know that a
patient is Lost to Follow-up and you have no survival information, submitting a Lost
to Follow-up Declaration (Form 2802) for that visit will remove that form from your
list. However, please note that a Lost to Follow-up Declaration only applies to the
time period in question, and at the next follow-up time point for that patient another
form will be due.
There is a form showing due that was submitted prior to the release of
FormsNet. Do I have complete it again?
If a form was previously submitted to the legacy databases, but it is still showing up
as due, contact your liaison. Please don’t duplicate the data; it is likely that this can
be corrected on your behalf.
What if the wrong disease specific form is due for a patient (or no disease form
is due)?
FormsNet probably has the wrong disease listed for your patient. Contact your
liaison to verify.
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What if a BMT CTN patient is assigned to a Post-TED?
In general, all patients enrolled on a BMT CTN study require a Comprehensive
Report Form (CRF). The assignment to the CRF track is based upon your center
submitting the correct study information on the Pre-TED (Form 2400). When
completing a Pre-TED Form for a BMT CTN patient, please be sure to check the
“BMT CTN” tick box on page 1 (upper left hand corner of paper form) and provide
the 4-digit study ID number (i.e. 0101, 0201, 0702). Once the form is complete, the
selection algorithm will automatically set the patient to the CRF track. If a patient is
enrolled on a BMT CTN study AFTER the transplant has occurred (i.e. trials looking
at the management of post transplant complications), and the recipient has already
been registered in FormsNet, they will remain on the forms due track to which they
were originally assigned. For example, a recipient who underwent an allogeneic HCT
for AML and was originally assigned to TED level reporting then developed a post
transplant complication for which they were enrolled on a BMT CTN study; they
would remain on the TED level reporting track for follow up. In the event your
center discovers a BMT CTN patient was not properly registered with the CIBMTR
(i.e. you never checked the BMT CTN tick box on the Pre-TED or you need to update
the recipient’s status to BMT CTN), please contact your liaison to update the
reporting status. If you have any questions or concerns regarding CIBMTR data
reporting requirements for BMT CTN patients, please contact Kavita Bhavsar
at kavitab@mcw.edu.
I have the same patient listed twice with different CRIDs. What should I do?
If you are concerned that you have two CRIDs assigned to the same patient, contact
your liaison about resolution.
General Questions
What does CIBMTR consider a “product?”
The CIBMTR defines a single product (i.e., stem cell product) as cells collected from a
single donor using the same mobilization cycle and collection method regardless of
the number of collection days. For more information on defining a product, see
Appendix P of the Data Management Manual on CIBMTR.org. One mobilization cycle
may have multiple days of collection, and/or multiple bags collected. As long as
these are all collected using the same collection method (i.e., aspirate, apheresis),
then these are considered portions of a single product. Your lab may have a different
definition of a product than CIBMTR. Many labs consider each collection a separate
product. Be aware of this when reporting to CIBMTR.
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How are multiple collections handled, then?
Because the values are all from the same product, the values from each bag need to
be combined to report one instance. All cell counts need to be added together, and
the viability should be averaged. More information on reporting on the infusion
form is available here.
How do I tell what registry my product came from?
Documentation included with the product should provide the information needed to
determine the source of the cells. If you do not have access to this information, and
the source is not indicated in any of your records, you will need to speak with the
search coordinator who requested the unit. The CIBMTR recommends that you
develop a process at your center where this information is routinely noted in the
record or provided to the data management staff. If you have any questions on how
something should be reported, feel free to contact your liaison or Jenni Bloomquist
(jbloomqu@nmdp.org).
Why is the CIBMTR asking for stem cell processing records on cords and how
should they be submitted?
After a pilot review of cord blood data already submitted, the CIBMTR found a
higher than desired error rate for fields related to the processing of the product,
including nucleated cell count, viability, and sterility information. Data related to the
thawing and processing of a cord blood unit are complicated but critical to analysis
of the quality of the unit. By having these reports sent along with the forms we will
be able to work through any questions about the data before contacting you.
Please de-indentify these reports and write the CIBMTR Recipient ID (CRID) on each
page. Send them with a completed Log of Appended Documents (Form 2800) to
your assigned campus. CIBMTR staff will review your documents and send you an
email with any corrections that are identified. If you notice any corrections that
need to be made in the process of pulling these records, feel free to make those
changes directly in FormsNet. If you have any questions on how something should
be reported, feel free to contact your liaison or Jenni Bloomquist
(jbloomqu@nmdp.org). The CIBMTR recommends that you develop a process at
your center where these forms are automatically sent to the CIBMTR when a cord
blood transplant happens. This will avoid the need for multiple requests for this
information.
EBMT Registration
How is CRID assignment going to work for EBMT patients that are received
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through their ProMISe database?
If data comes to CIBMTR from the ProMISe system and the EBMT has the
appropriate agreements in place with the transplant center, the CIBMTR will assign
a number based upon the EBMT CIC/UID (Center Code and Unique ID). It will then
enter those data. Teams do not need to independently apply for a CRID for any
patient where the data will be submitted through ProMISe.
EBMT teams wishing to provide TED/MED-A data directly to CIBMTR via FormsNet
2 should contact their liaison and ensure that the EBMT CIC/UID fields are properly
filled in.
Forms Specific
For general forms questions, please review the Data Management Manuals posted
on cibmtr.org before contacting your liaison with questions.
Comprehensive Report Forms
How do I report that a patient consented for research?
Consent for autologous patients is captured on the 2804 Unique ID Assignment /
CRID form. Centers should answer question 8 as either yes or no depending on if the
patient signed consent to send CIBMTR research data for their autologous
transplant. Please note - Question seven refers to the CIBMTR storing and creating a
dataset for your autologous recipients – this requires prior approval, an Amended
Data Transmission Agreement and is only available to US centers at this time.
Consent for allogeneic related and unrelated patients is captured on the 2400 PreTransplant Data form as well as the 2000 Baseline form if there are Comprehensive
Report Forms due in FormsNet. Centers should answer whether or not the patient
consented for research on the 2400 Pre-TED form as yes or no if consent was given
or not for their transplant. Centers should also answer question 408 on the 2000
Baseline form (revision 2) as either yes or no depending on if the patient signed
consent to send CIBMTR research data for their transplant.
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When should I complete Infusion (2006), Infectious Disease Markers (2004),
and HLA Typing (2005) forms?
Form 2004 (IDM) and Form 2005 (HLA) are due for each non-NMDP (related or
unrelated) product (regardless of your center reporting preferences) when assigned
to the Comprehensive Report Form track or when then patient has consented to
participate in the Related Specimen Repository (pilot phase) or when the product is
cord blood. Form 2005 (HLA) is also due for the recipient in these cases. IDM (2004)
and HLA (2005) forms should not be completed for autologous patients or for
NMDP transplants.
Form 2006 is due for each NMDP product or Cord Blood product (regardless of
track assignment and research consent). It is also due for each product when patient
is assigned to the Comprehensive Report Form track and when then patient has
consented to participate in the Related Specimen Repository.
Form 2011 – Acute Lymphoblastic Leukemia
An error has been identified.
An error has been identified in Form 2011 Pre-HSCT ALL. The header above Q121123 is correct. The labs should be the last obtained just prior to the start of the
preparative regimen. The instruction just below the header, but above Q121, is
wrong and will be removed. The labs should NOT be the ones before first treatment.
This will be updated with the next version of the form.
Form 2012 – CML Pre-HSCT Disease Specific Form
If a patient has a major cytogenetic remission, that means they have not
attained a full cytogenetic remission, so would I check off ‘No’ for question 49?
I noticed FormsNet allows you to check minor or major with ‘Yes’ or ‘No’ to Q.
49.
Any complete cytogenetic remission (no cells with Ph Chromosome positivity by
FISH or conventional cytogenetics) is a subset of major cytogenetic response
(remission), where major cytogenetic response includes patients with complete
cytogenetic CR (0% Ph positive) and partial cytogenetic CR (1-35% Ph positive
cells) response.
Q49 is intended to ask whether there has been any cytogenetic remission or
response (not just a complete cytogenetic remission).
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Q50 collects categories of response, grouping major and complete cytogenetic
response together, and minor cytogenetic response (36-95% ph+ detectable).
For this example, with a major cytogenetic response, Q49 should be ‘yes’ and Q50
should be ‘major.’
The validation for these questions will be adjusted accordingly in a future FormsNet
2 release.
Form 2118 – Hodgkin and Non-Hodgkin Lymphoma
When filling out questions 3(4-5), 40(41-42), and 43-48, I am looking for
clarification of what a “molecular assessment” is defined as, as well as a
“clinical/hematologic assessment.” For example, I have a patient who has
biopsy proven nodal recurrence post-transplant, and I do not know which
method of assessment to mark. In the past, a molecular assessment has been
along the lines of a molecular marker, such as BCR-ABL. In this context, a
biopsy proven nodal recurrence will be marked under clinical/hematological.
Clinical/hematologic testing is the lowest level of resolution. Examples include
circulating blasts in the bloodstream for AML, or enlargement of a malignant mass
for lymphoma or a solid tumor, as determined either physically or radiographically.
Cytogenetic assessment involves testing blood or bone marrow for the presence of a
known cytogenetic abnormality that reflects the disease for the patient. The patient
must have had “positive” cytogenetics at some point in their past history to make
this a valid assessment method. Molecular assessment involves determining
whether a molecular marker for the disease exists in the blood or marrow.
Examples of this latter include bcr/abl as a marker of CML. Molecular assessment is
the most sensitive method of detection. It is so sensitive that some centers may look
for a pattern of increasing detection before considering the presence of a marker to
be “true relapse”. This should be discussed with the physician caring for the patient.
(see guidance from CIBMTR – Reporting Disease assessments…pdf)
Form 2801 – Request for Recipient Transfer
We have a patient who received all treatment in another state and transplant
at another center. She has family in our state and she is possibly going to want
to be seen at a new center for follow-up only. Does she also need a CRID
number?
The patient will have a CRID already from the center that did the HCT. The reporting
will still be the responsibility of the first center, unless your center agrees to submit
the follow-up. That is entirely up to your center. If you wish to take over the followup reporting, you’ll need to complete a Form 2801 – Request for Recipient Transfer.
Your other option is to send follow up records/data to the original center so that
they can complete the follow-up forms. LINK TO MEETING PRESENTATIONS
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Form 2802 – Lost to Follow-up Declaration
How does the team report lost to follow-up patients?
Complete Form 2802 - Lost to Follow-up Declaration. Note that the designation, lost
to follow-up, requires continued confirmation. Lost to Follow-up Forms should be
completed on paper and submitted to the appropriate data entry location. Lost to
follow-up should be designated for the first interval for which there was no
information acquired for the patient.
What is the procedure to follow when a patient who was lost to follow-up
returns to our center for follow-up?
If the patient re-appears between years of follow-up, you should report the data for
this patient at the time of the next form due, which will be annually until year 6 then
every other year thereafter in FormsNet. The data to be reported will include ALL
CLINICAL EVENTS THAT HAVE OCCURRED BETWEEN LAST CONTACT BEFORE
LOST TO FOLLOW-UP AND THE MOST RECENT CONTACT.
DCI
Patient DCI is showing up as HCT so the forms due dates are being based on
the DCI date instead of the HCT date. How can this be corrected?
The CIBMTR had uploaded Patient Forms Due in FormsNet2 in December 2007 for
unrelated (non-NMDP) and related donor recipients who previously had a DCI/DLI
as reported in the legacy database. Patients included in the “legacy database” are
those where the initial HCT was before December 3, 2007. The forms due for these
patients were set up based on the most recent DCI date rather than the previous
HCT anniversary date. CIBMTR worked to remove the forms due for these patients
in early 2008 until a clean-up could be completed in FormsNet2. This was done to
reduce confusion and prevent any duplication of effort by completing more Forms
than necessary. If any Forms were already completed, those were not deleted.
It is likely that if forms were already completed, that they may have been completed
for the DCI date rather than the HCT date. In addition, it is possible that not all DCI
patients were identified and they still have forms due based on the DCI date in
FormsNet2. If this is the case, liaisons should be contacted to make these corrections
as the forms due should be based on the previous HCT date and not the DCI
anniversary date.
CIBMTR is working on completing a mass clean-up of all recipients who have
received a DCI as reported in the legacy database. There may be some cases that
require further follow up and you will be contacted about those cases by e-mail.
Appendix O: How to distinguish infusion types http://www.cibmtr.org/DataManagement/TrainingReference/Manuals/DataManag
ement/Documents/appendix-o.pdf
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What is a KGF study form and should I complete it?
The forms included in the KGF study include the 2503 (legacy patients only) and
2504. If a patient receives KGF, the patient will be assigned to the CFR track for
follow-up. CIBMTR statisticians will then find another case in the database to match
your patient to someone that did not receive KGF. At that point, both your patient
and the matching patient that did not receive KGF will be added to the study and the
supplemental forms (2504) will be made due. If you believe that your center has
declined to participate in this study, but you see that a KGF form is due, contact your
liaison to review the case.
I reported a fungal infection was present prior to transplant and now there
are post-transplant fungal forms due as well. Is this correct?
CIBMTR requests that information on the fungal infections be captured for 6 months
after the infection is reported. This means that if a fungal infection is reported
within 6 months of the start of conditioning, a 2046 will be due at baseline and a
2146 will be due at 100 days and 6 months. If the infection is reported on the 100
day report, the 2146 will be due at that visit and the 6 month visit.
Ted Forms
Form 2400 - Pre-TED Reporting
What is the related sample repository?
CIBMTR is working with specific centers to have them send in blood samples from
patients that have received an allogeneic related transplant. Only answer this
question as yes if you have confirmed with CIBMTR that you are participating in this
study.
While searching our Center Forms Due, some showed up that are not our
patients.
It appears that the incorrect center ID may have been entered. These situations with
CRID numbers require that the center contact their liaison.
Pre- and Post-TED Reporting
What if a patient expires before transplant? Do I submit a form indicating
he/she never received a transplant? If so, which form?
If the patient expires before they begin their preparative regimen, you are not
required to submit a CRID form or any data. If a CRID form was submitted prior to
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knowing about the death, contact the team liaison to have this patient removed from
the system.
If the patient receives even just the first dose of the prep reg, then forms will be
required. Request a CRID as you would normally do and indicate the intended
transplant date. Complete your Pre-TED (Form 2400). If CRF forms are made due,
contact your liaison to switch the forms to the TED track. Complete the Post-TED
(Form 2450) for the 100 day visit. Advise your liaison that the future forms need to
be removed if they do not go away on their own. A Death Report (Form 2900) will
not be required.
FormsNet Specific
FormsNet
FormsNet will not accept my donor identification number. What should I do?
Revision 2 of the Infusion Form (2006) has validation on the NMDP Donor and Cord
Blood ID fields to ensure that only valid NMDP IDs are entered into those fields. If
you are entering data into those fields that is being rejected, first make sure that
there are no dashes in your ID. If there are letters in your ID, it is not an NMDP ID.
In the case of a donor/cord that was found by the NMDP via a cooperative
agreement with an international registry, select non-NMDP donor or non-NMDP
cord blood unit on the key page of the Infusion Form (2006) and the Pre-TED
(2400). These donors/units are available to be searched because of an agreement
that the NMDP has with another international registry; they are not “NMDP Donors.”
In order to appropriately identify the source of the product, you need to report the
registry that has that donor/unit listed, rather than the NMDP.
What browser should I be using to complete forms in FormsNet?
At this time, FormsNet is only completely supported in Internet Explorer 6. Other
browsers will run FormsNet, but not all features may be available. The new version
of FormsNet will be compatible with multiple operating systems.
What should I do if I try to correct an error on a form and FormsNet2 tells me I
am not authorized to access that form?
Forms 2800 (Log of Appended Documents), 2801 (Recipient Transfer), and 2802
(LTFU Declaration) cannot be keyed by centers in FormsNet2. These forms must be
submitted on paper to your assigned campus. Because of the volume of these forms
received by CIBMTR, it may take a few weeks for CIBMTR’s data entry to enter these
forms. If you notice that these forms have been on your list for more than a month,
contact your liaison to look into the case.
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There was a short period of time where FormsNet allowed centers to complete
these forms electronically. However, this functionality was removed because these
forms are intended to be completed on paper. If you entered one of these forms in
FormsNet, and the action that you requested was not completed (transferring the
patient, making a form Lost to Follow-up), please send a paper error correction to
your assigned campus to resolve the errors on the form. This will trigger the action
to be completed. Please note: If a transfer form (2801) was only authorized by one
center, a paper copy needs to be sent to both centers for a signature and then faxed
to the CIBMTR for processing.
A question in FormsNet is giving me an error, but the information is correct.
What do I do?
The CIBMTR has established reference ranges for some of the values (see Appendix
F for details). If you have verified that the value you reported is indeed correct,
including the unit of measure, then you can use the Verified Correct override code to
bypass the error. Do this by clicking on the red bubble next to the question
indicating an error, or from the Queries Review page.
In addition to these, there is also validation on a number of fields to help guide you
through completing the forms. In some cases, the validations are still under
development and will be available in a future release of FormsNet. If you receive a
error message on one of these fields and you’ve reviewed your answer and it is
correct, report the problem to your liaison if you have not done so already. Until the
functionality for these validations is added to FormsNet, you can bypass the error by
using the “Unable to Answer” override code.
Amnesty Plan
Amnesty Letter/Spreadsheet
Amnesty Plan Definition:
The Stem Cell Therapeutic Outcomes Database (SCTOD) of the C.W. Bill Young
Transplantation Program launch brought significant changes for transplant centers,
including the adoption of the NMDP’s Continuous Process Improvement (CPI) for
Forms Submission, which assesses and maintains standards for timely and accurate
completion of required forms. As of December 3, 2007, this program included all
new CIBMTR forms. In order to help centers prospectively focus on data submission
for the CIBMTR, we developed a plan to alleviate the burden of historic unsubmitted data a.k.a ‘backlogged forms.’ The plan did NOT affect any cases involving
NMDP-facilitated HCTs.
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The Amnesty Plan letter and Forms Due spreadsheet were sent to all active CIBMTR
centers in January 2008. The Forms Due spreadsheet can provide a historical
context of what is due in FormsNet2 now, but should not be used as the source of
what is due for a patient currently, as there have been other changes to reporting
since these reports were generated. FormsNet2 should be consulted in order to find
out what forms need to be completed for a patient.
Link to Amnesty Plan Letter:
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