April 2018 Forms Instruction Manual Updates

In case you missed them, here are the changes made to the Forms Instruction Manual during the month of April. Check the Getting Started  page of the Forms Instruction Manual for a list of the most recent updates. Updates made after March 2015 are always available for reference in the Historical Manual Updates  section.

Date Manual Section Edit Type Description
4/30/18 2450: Post-TED Add Added the following instruction for question 34.Please note, questions 35 and 36 must still be answered if question 34 is reported as "unknown."
4/30/18 2450: Post-TED Modify Updated language on how to report the "Date of most recent disease assessment" for questions 237-238: current disease status.
4/23/18 2018: LYM Pre-Infusion Data Modify Corrected errors in the instruction manual by adding (in red below) and removing (struck out below) text to the instructions for questions 269-272, 273-276, and 277-280.
Indicate the result of [method] testing performed at the last evaluation prior to the start of the preparative regimen / infusion. If testing was "Positive," or "Negative," report the sample source in questions [question numbers]...
If all [method] testing was negative or testing was not done at the last evaluation prior to the start of the preparative regimen, report "Negative" or "Not done" respectively...
4/20/18 Appendix M: Critical Data Fields Modify New version of Appendix M: Critical Data Fields of the Forms Instructions Manual released. Note, prior versions of this appendix were referred to as Appendix Y: Critical Data Fields.
4/20/18 4003: Cellular Therapy Product Add Added Cryopreservation as a Manipulation note box to the instructions for questions 31-32.
4/16/18 2000: Recipient Baseline Add Added Fungal Infection Diagnosis Reporting Scenario to the instructions for question 57.
4/10/18 2402: Disease Classification Modify Updated the Common Disease Transformation Table included in the instructions for questions 1 and 2. The CLL section of the form should not be completed for a Richter's Transformation as of Revision 3 of the Form 2402.
4/10/18 4006: Cellular Therapy Infusion Add Added in additional clarification regarding total cell counts administered, what constitutes unselected lymphocytes, and T-helper cells (Q17-24).
4/9/18 2402: Disease Classification Modify Modified the following instruction for question 317:
Enter the date of the most recent assessment of disease status prior to the start of the preparative regimen. Report the date the blood/urine was collected for the laboratory evaluations (e.g., SPEP/UPEP, serum/urine immunofixation) or report the date the bone marrow was collected for pathological evaluation. PET scan Date of radiographic study (PETMRI, CT) may be used if the same a previous PET scan radiographic study had previously been obtained and only in limited circumstances (e.g., plasmacytomas, lytic lesions).

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