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Tips for Submitting Forms

9:30 AM – 10:30 AMFebruary 23, 2010

Track 1 Beginner

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Sandra Halvorson, BA, CCRPClinical Research Coordinator

Minneapolis Campus

Tips for FormsNet™2 (FN) Use

FN is a Web-based forms submission application2 Landing Pages

Home and Recipient Landing PageWhat is it? Communication page Announcements posted for centers

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Announcements posted for centers

Search by Identification Number(s)

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Sort by Filters

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Change

Symbol

Color

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Sort by Filters

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Center’s Forms Due Search

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Export Forms Due List to Excel

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Forms Submission Process

First HSCTAssign CRID number - Form 2804 (Unique ID Assignment Form)Complete Form 2400 (Pre-TED)

• Algorithm selects CRF or TED track CRF – Comprehensive Report Forms

Long forms - Pre and Post HSCT forms

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Long forms - Pre and Post HSCT formsPre HSCT - 2000 series Post HSCT – 2100, 2200 and 2300 series

Post-TED – Ted Track formsShort formPre-HSCT – 2400 seriesPost-HSCT – 2450, 2455 series

Forms Submission tips

Submit data online via FormsNet™2*All US centers and most international centers

Required Paper Form SubmissionF2802 – Lost to Follow-up

•Only submit LTF if there is no data

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• F2800 – Log of Appended Documents***Include CRID number on every Document page

F2801 – Request for Recipient Transfer•Must be signed by both centers

• Send Paper forms to respective campus

Form 2804 – Unique ID Assignment

When is it Due?First reported HSCT

Purpose – assign unique ID number

Why?

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To comply with privacy regulations FDA and HIPAA requirement

Only one CRID number/recipient

A second CRID number is never assigned for any reason

F2804 Questions 1 and 2 clarificationQ #1 and 2 – Refers to Auto’s only Q #1 - Some centers have modified the DTA (Data Transmission Agreement) to utilize CIBMTR’s database to store all of their data. (Does not refer to consent)Q #2 – Refers to recipient’s consent for th i d t t b d f h

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their data to be used for research.

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F2804 Tips

Report all ID numbers – NMDP-RID, IUBMID, EBMTID etc.Report as much ID information as allowed.

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F2400 TipsCTN Study numberConsent for ResearchConsent for Related Specimen RepositoryRace (See Manual)

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F2400Date of HSCT Chronological # of HSCTIf >1 previous HSCTCell source

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F2400 Tips

Donor Type AutologousAllogeneic RelatedAllogeneic Unrelated

N b f d t

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Number of products

Single product = from same donor, same mobilization/method even if collected on different days.

F2400 Unrelated donor

Select the Registry – select from drop down menu or go to www.bmdw.org

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F2400 Registry Codes

NMDP Donors Registry Code for PBSC or Marrow

Use USA1 code for Q#25Registry Code for Cord Blood

Use U1CB code for Q#25

Non NMDP Donor

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Non NMDP DonorRegistry Codes for Marrow, PBSC and Cord Blood

Use the drop down menu in FormsNetUse codes at the Bone Marrow Donor Worldwide website. http://www.bmdw.org/index.php?id=addresses_members&no_cache=1

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F2400 Registry Codes

www.bmdw.org (Bone Marrow Donor Worldwide website)

Addresses tabParticipating Registries tabSearch by country center etc

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Search by country, center etc.

Example – Donor from DenmarkBone Marrow Donors Copenhagen (BMDC)

Code = DK2

F2400 Registry Codes

Bone Marrow Donors Copenhagen (BMDC) Match Codes: Denmark – BMDC [DK2]

Code = DK2

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F2400 NMDP vs. non-NMDP Donor

NMDP Donor CriteriaDonor has been facilitated through the NMDP.

Donor Center has submitted donor forms 22, 24 and 50. Registry Codes = USA1(BM/PBSC) or U1CB(CB)

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Non-NMDP Donor CriteriaDonor may or may not have been facilitated by the NMDP

Donor Center has NOT submitted donor forms 22, 24 and 50. Use Registry codes from drop down menu or the www.bmdw.org website.

F2400 Tips Disease

AMLAML transformed from MDS or MPS

Complete both MDS and AML disease section.

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MDSMDS transformed to AML

Indicate AML as primary disease and complete both AML and MDS disease sections.

F2400 Disease Tips

Refer to the PreTed Manual • www. cibmtr.org • Data Management - tab• Training and Reference – tab• Manual - tab

Definitions and Criteria:Disease status at transplantation

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Disease status at transplantationPrimary Induction FailureComplete RemissionRelapseChronic PhaseHematological RemissionCytological RemissionMolecular RemissionEtc.

CRF vs. Ted Forms

F2400 completed - algorithm selects Ted or CRF track

Comprehensive (CRF) vs. TED Track

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1. CRF Track – all follow-up forms will be CRF.2. Ted Track – all follow-up forms will be Ted

Track.

FormsNet™2 vs. Paper version

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TED Track Forms

FN

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Paper

Comprehensive Forms

FN

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Paper

Post-TED Track

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Post-TED Forms

PurposeCollects post HSCT dataReport Subsequent HSCT dataReport DeathReport Cancelled HSCT

F

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Forms2450 and 2455

Due100 Day6 MonthAnnually

F2450 HSCT DateHSCT Date & Number

***Report Subsequent HSCT & Date

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***Autologous Rescue? Not an HSCT. Treatment for graft failure only. Not for treatment of disease. (No F2400 due)

F2450 How to Report Subsequent HSCT

Q#949 Report Subsequent HSCTQ#950 HSCT date

Makes subsequent transplant F2400

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p(Pre-Ted) form due

***Q#951 Autologous Rescue? Treatment for graft failure only. Not an HSCT. Not used for treatment of disease. (No new F2400 due)

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F2450 Report Cancelled HSCTAnswer Q#1- 7 on F2450-100 Day Q#2 Was HSCT infusion given? = NOContinue with Q#3-7

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F2450 Report Death

Report Death, Date and Cause.

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***Do not report death on F2900

F2450 How to Report Death

Paper Form - Report Death Q62-74Q#62-64 Date of DeathQ#65-74 Cause of DeathQ#66-73 HSCT Related

(Multiple Choice)

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Pick only onemain cause

Do Not report death on F2900

Comprehensive Report Forms

Due Pre HSCT 100 day6 th

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6 monthAnnuallyDeath

Disease insertsDue for each reporting period

Comprehensive Baseline Forms Key Fields F2000, F2006, F2004 & F2005

Key Fields – Specify Donor TypeNMDP Unrelated CBU ID#NMDP Unrelated Donor ID (Not NMDP-RID#)

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*Submitted F50, F22 & F24

Non-NMDP DonorRelated & UnrelatedCBU – Auto, Related &

Unrelated*Not Submitted F50, F22 or F24

How to Report Subsequent HSCT

Answer question relating to “Did recipient receive subsequent HSCT…?” and continue with the follow-up questions for HSCT.

Form 2100 (100 day) = Q#5

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Form 2200 (6 month-2 year)= Q#2Form 2300 (years 3+) = Q#3

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Reporting Subsequent HSCT

Subsequent HSCT follow-up questions

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How to Report cancelled HSCT

Comprehensive form F2100 – 100 day Answer Q#2

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**Continue with data submission

Reporting Death

Report DeathF2100 (100 day report) = Q#6F2200 (6 month - 2 year report) = Q#3F2300 (3 plus year report) = Q#4

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Report death details on F2900

How to Report Death

Death Form F2900Only for Comprehensive TrackNot used for TED track

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Disease Inserts

Due for CRF forms onlyDue for Every Reporting PeriodThere Can Be Multiple Inserts Due

Example F2010 AML

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Form 2004Infectious Disease Marker

F2005

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F2005 HLA Typing

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F2004 & F2005

Forms Due?Due: for non-NMDP donors who have consented for Related Sample Repository and/or Cord Blood transplants.

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Not Due: for TED Track non-NMDP donors if recipient has NOT consented for Related Sample Repository.

**non-NMDP donor = Donor center has not submitted F50, 24 and 22

F2004 Infectious Disease MarkerPurpose

Indicates a donor has or previously had an infectious disease that could be transmitted to recipient.

Test ResultsReport Final Test Results

Refers to either initial screening or confirmatory test

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test.If screening test is negative = final test resultIf Screening test is positive a confirmatory test might be completed = final test result.

Test Date – date lab conducted test.Report Results as

Reactive, non-Reactive, Not Reported or Not performed

F2004

Who is Being TestedTest Results – report final test results

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F2004

Q#2-23 Infectious Disease MarkersRefer to Forms Manual for reporting and definitions

Q#25-36 - Other Infectious Disease MarkersChagasE t i B Vi

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Epstein-Barr VirusHerpes Simplex VirusToxoplasmosisSickle Cell ScreenVaricella Zoster VirusAnti-HBsAnti-HBeWNV done by ELISA

F2005 HLA TypingQ#1 Specify who the HLA typing is for?**A separate form should be completed for

each donor, recipient and cord blood unit. e.g. 2 CB units = 3 HLA forms (2CBU and 1 Recip)

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#4 Specify Other = Aunt, Uncle, Cousin, Twin etc.

F2005

DNA Typing - High Resolution TypingCan be used to type single allele, combination of alleles or a “generic” allele. Number of digits and number of alleles

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will varyBoxes are provided for reporting several possible combinations at each locus. **Questions for DNA reporting are labeled 6d-16d

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F2005

Serological Typing – Low resolution typing or generic typing

Allows a preliminary view of likelihood of a match.Faster and less expensive

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Faster and less expensive **Questions for serological typing are labeled 6s-16s

F2005

For further typing clarification or questions contact:

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Maria Brown612-627-8186mbrown2@nmdp.org

Questions

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