CDE Detailed Report
Disease: general-data-protection-regulation-gdpr
Sub-Domain: Protocol Experience
CRF:
Sub-Domain: Protocol Experience
CRF:
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Additional Notes (Question Text) | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guideline) | Sub Domain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C58706 | Focal neurological event abnormal T2 FLAIR acute infarct indicate code | FocNeuEvAbnT2FLRActIfctIndCode | Code indicating whether the subject/participant has had a focal neurological event with abnormalities indicative of an acute infarct on T2-weighted or FLAIR images. | Code indicating whether the subject/participant has had a focal neurological event with abnormalities indicative of an acute infarct on T2-weighted or FLAIR images. | Has the patient experienced a focal neurological event resulting in abnormalities on T2-weighted or FLAIR images using an MRI scan, indicative of an acute infarct, with no other reasonable medical explanation? | 1;2;3 | Yes;No;Unavailable | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 10:11:57.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCNEUEV | |||||||||||||||||||||||||||
| C58738 | Creatinine clearance most recent measurement | CreatininClearMostRecntMeasr | Measurement of creatinine clearance from the most recent sample taken from the subject/participant | Measurement of creatinine clearance from the most recent sample taken from the subject/participant | Creatinine clearance most recent value (mL/min/1.73m^2) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 12:09:07.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
0 | 999.99 | milliliter per minute per 1.73 square meters | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCRCL | ||||||||||||||||||||||||||
| C58787 | Solid phase immunoassay determine HLA antibody presence specificity perform date | SolPhImsDtHLAAbdyPrsSpfPfDate | Date on which solid phase immunoassay was performed to determine HLA (human leukocyte antigen) presence and specificity. | Date on which solid phase immunoassay was performed to determine HLA (human leukocyte antigen) presence and specificity. | Date solid phase immunoassay performed to determine HLA antibody presence and specificity | Date or Date & Time |
HLA antibody presence and specificity will be determined by solid phase immunoassays. An anti-donor specific HLA antibody will be considered positive when the mean fluorescence intensity (MFI) is higher than the cut-off defined by each institution. Recommended cut-off values are MFI >1000 for donor specific antibody to HLA-A, -B, and DRB1 and MFI >2000 for HLA-C, DQB1 and DPB1. |
Adult;Pediatric | Proposed | 1.00 | 2018-12-11 12:05:15.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCIMMDT | ||||||||||||||||||||||||||||
| C58717 | History pain crisis sickle related complication over two per year prior enrollment indicate code | HxPnCrScReCoOv2PrYrPriEnrInCod | Code indicating whether the subject/participant has a history of three or more vaso-occlusive pain crises per year prior to enrollment despite supportive care; or painful episodes related to priapism, osteonecrosis, or any sickle-related complication. | Code indicating whether the subject/participant has a history of three or more vaso-occlusive pain crises per year prior to enrollment despite supportive care; or painful episodes related to priapism, osteonecrosis, or any sickle-related complication. | Does the patient have a history of three or more severe vaso-occlusive pain crises per year in the two-year period preceding enrollment despite the institution of supportive care measures (i.e. a pain management plan and/or treatment with hydroxyurea); painful episodes related to priapism, osteonecrosis or any sickle-related complication? | 1;2;3 | Yes;No;Unavailable | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:06:28.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCVOC | |||||||||||||||||||||||||||
| C58750 | Red blood cell transfusion 8 times year 20 times ever indicate code | RBCTrsfn8xYr20xEvrIndCode | Code indicating whether the subject/participant has received packed red blood cell (RBC) transfusions totalling either 8 or more times per year for at least one year, or at least 20 times over his or her lifetime. | Code indicating whether the subject/participant has received packed red blood cell (RBC) transfusions totalling either 8 or more times per year for at least one year, or at least 20 times over his or her lifetime. | Is the patient currently receiving >= 8 packed red blood cell transfusions per year for >= 1 year or has the patient received >= 20 packed red blood cell transfusions (lifetime cumulative)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:29:15.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCBRBC | |||||||||||||||||||||||||||
| C01554 | Oxygen saturation measurement | O2SatMeasr | Value, as a percent, of baseline O2 saturation (SPO2) in nocturnal oximetry, as part of Nocturnal Oximetry. | Value, as a percent, of baseline O2 saturation (SPO2) in nocturnal oximetry, as part of Nocturnal Oximetry. | Record patient's O2 saturation | Numeric Values | Adult;Pediatric | Proposed | 3.00 | 2013-07-22 16:57:17.79 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
0 | 100 | percent | DeBaun Forms | |||||||||||||||||||||||||||||
| C58728 | Performance status scale code | PerformanceStatusScaleCode | Code for the scale used to evaluate the subject/participant's performance status. | Code for the scale used to evaluate the subject/participant's performance status. | Performance status scale used to evaluate patient (Lansky for patients < 16 years old; Karnofsky for patients >= 16) | 2;1 | Lansky;Karnofsky | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:18:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSS | |||||||||||||||||||||||||||
| C58771 | HIV positive serology infection indicate code | HIVPosSerolInfectIndCode | Code indicating whether the subject/participant has evidence of either HIV (Human Immunodeficiency Virus) infection or HIV positive serology. | Code indicating whether the subject/participant has evidence of either HIV (Human Immunodeficiency Virus) infection or HIV positive serology. | Does the patient have evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 16:10:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHIV | |||||||||||||||||||||||||||
| C58707 | Focal neurological event abnormal T2 FLAIR acute infarct most recent date | FocNeuevAbnT2FLRAcInMsRcDate | Date of the subject/participant's most recent focal neurological event with abnormalities indicative of acute infarct on T2-weighted or FLAIR images. | Date of the subject/participant's most recent focal neurological event with abnormalities indicative of acute infarct on T2-weighted or FLAIR images. | Date of most recent focal neurological event resulting in abnormalities on T2-weighted or FLAIR images using an MRI scan | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 10:18:17.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSTRDT | |||||||||||||||||||||||||||||
| C58739 | Creatinine clearance sample date | CreatininClearanceSampleDate | Date on which the sample for creatinine clearance measurement was taken from the subject/participant. | Date on which the sample for creatinine clearance measurement was taken from the subject/participant. | Date creatinine clearance sample obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 12:12:19.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCRDT | |||||||||||||||||||||||||||||
| C58788 | Mean fluorescence intensity donor specific antibody exceed limit indicate code | MnFluoIntDonSpfAbdExcLtIndCode | Code indicating whether the MFI (mean fluorescence intensity) for donor specific antibodies exceeds allowable limit. | Code indicating whether the MFI (mean fluorescence intensity) for donor specific antibodies exceeds allowable limit. | Was MFI >1000 for donor specific antibody to HLA-A, -B, DRB1 and/or MFI >2000 for HLA-C, DQB1 and DPB1? | 1;3;2 | Yes;No;Yes, approved by Protocol Char and/or Protocol Officer | Numeric Values |
HLA antibody presence and specificity will be determined by solid phase immunoassays. An anti-donor specific HLA antibody will be considered positive when the mean fluorescence intensity (MFI) is higher than the cut-off defined by each institution. Recommended cut-off values are MFI >1000 for donor specific antibody to HLA-A, -B, and DRB1 and MFI >2000 for HLA-C, DQB1 and DPB1. |
Adult;Pediatric | Proposed | 1.00 | 2018-12-11 12:10:33.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCMFI | ||||||||||||||||||||||||||
| C58718 | Pain crisis 2 year prior enrollment start date | PnCris2YrPriorEnrolStartDate | Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication two years prior to enrollment. | Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication two years prior to enrollment. | Start date of severe pain crisis 2 years prior to enrollment | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:12:39.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSC2P1DT | |||||||||||||||||||||||||||||
| C58751 | Liver MRI hepatic iron content valid methodology indicate code | LivrMRIHepatcIrnCntntIndCode | Code indicating whether a liver MRI (magnetic resonance imaging) was performed using a validated methodology for estimation of hepatic iron content. | Code indicating whether a liver MRI (magnetic resonance imaging) was performed using a validated methodology for estimation of hepatic iron content. | Was a liver MRI performed using a validated methodology per institutional preference (T2* or R2* or by ferriscan [R2 MRI]) for estimation of hepatic iron content? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:35:20.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLMRI | |||||||||||||||||||||||||||
| C10179 | Diffusion Capacity Corrected measurement | DiffusionCapacityCorrectdMeasr | Diffusion Capacity Corrected (DLCO CORR) = A correction for predicted value is made using patients Hemoglobin | Diffusion Capacity Corrected (DLCO CORR) = A correction for predicted value is made using patients Hemoglobin | Record patient's DLCO value (corrected for hemoglobin) | Numeric Values | Adult;Pediatric | Proposed | 3.00 | 2013-07-22 09:34:41.527 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| C58729 | Performance status result code | PerformanceStatusResultCode | Code for the result of the subject/participant's performance status using the Karnofsky or Lansky performance status scale. | Code for the result of the subject/participant's performance status using the Karnofsky or Lansky performance status scale. | Record patient's performance status | 02;03;04;05;06;07;08;09;10;01 | 90 (Normal Activity/Minor Restriction in Strenuous Play);80 (Normal Activity with Effort/Restricted in Strenuous Play);70 (Unable to Carry On Normal Activity/Less Time Spent in Play);60 (Requires Occasional Assistance/Minimal Active Play);50 (Requires Considerable Assistance/No Active Play);40 (Disabled/Able to Initiate Quiet Activities);30 (Severely Disabled/Needs Assistance for Quiet Play);20 (Very Sick/Limited to Very Passive Activity);10 (Moribund, Completely Disabled);100 (Normal, No Complaints/Fully Active) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:24:22.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSR | |||||||||||||||||||||||||||
| C58772 | Hematopoietic stem cell transplant previous indicate code | HTCPrevIndCode | Code indicating whether the subject/participant has received a previous hematopoietic stem cell transplant (HCT). | Code indicating whether the subject/participant has received a previous hematopoietic stem cell transplant (HCT). | Has the patient received a previous hematopoietic stem cell transplant (HCT)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 16:13:44.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHCT | |||||||||||||||||||||||||||
| C58789 | Protocol chair officer approve date | ProtocolChairOfficerAproveDate | Date on which the Protocol Chair and/or Protocol Officer approved a variance from study protocol. | Date on which the Protocol Chair and/or Protocol Officer approved a variance from study protocol. | Date of Protocol Chair and/or Protocol Officer approval | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 12:15:49.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCAPDT | |||||||||||||||||||||||||||||
| C58708 | Clincal radiologic evidence cerebral infarct 30 day prior enrollment indicate code | ClnRadEvCerInf30DyPrEnrIndCode | Code indicating whether there was clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Code indicating whether there was clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Was there clinical or radiologic evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 12:35:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCRECNE | |||||||||||||||||||||||||||
| C58740 | Hyperbilirubinemia indicate code | HyperbilirubinemiaIndCode | Code indicating whether the subject/participant has hyperbilirubinemia | Code indicating whether the subject/participant has hyperbilirubinemia | Does the patient have hyperbilirubinemia? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 12:14:07.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHYPER | |||||||||||||||||||||||||||
| C58719 | Pain crisis 1 year prior enrollment start date | PnCris1YrPriorEnrolStartDate | Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication one year prior to enrollment. | Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication one year prior to enrollment. | Start date of severe pain crisis 1 year prior to enrollment | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:12:39.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSC1P1DT | |||||||||||||||||||||||||||||
| C58752 | Liver MRI date | LiverMRIDate | Date on which liver MRI (magnetic resonance imaging) was performed. | Date on which liver MRI (magnetic resonance imaging) was performed. | Record date of liver MRI | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:42:35.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLMRDT | |||||||||||||||||||||||||||||
| C10724 | Echocardiogram performed date and time | EchcrdgrmPerfrmDateTime | Date (and time, if applicable and known) the echocardiography was performed | Date (and time, if applicable and known) the echocardiography was performed | Date echocardiograph was performed | Date or Date & Time | Adult;Pediatric | Proposed | 3.00 | 2013-07-25 08:54:08.2 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| C58730 | Cardiac fraction test type code | CardiacFractionTestTypeCode | Code for the type of cardiac fraction test performed. | Code for the type of cardiac fraction test performed. | Record the type of cardiac fraction test performed | 1;2 | Left Ventricular Ejection Fraction (LVEF);Shortening Fraction | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:37:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCFT | |||||||||||||||||||||||||||
| C58775 | Transplant solid organ ever receive indicate code | TrpltSldOrgnEverRcvIndCode | Code indicating whether the subject/participant has ever received a solid organ transplant. | Code indicating whether the subject/participant has ever received a solid organ transplant. | Has the patient received a prior solid organ transplant? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 09:45:45.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCORTXP | |||||||||||||||||||||||||||
| C58790 | Donor bone marrow willing indicate code | DonrBoneMarwWillIndCode | Code indicating whether the donor is willing to donate bone marrow. | Code indicating whether the donor is willing to donate bone marrow. | Is the donor willing to donate bone marrow? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:00:20.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDWILL | |||||||||||||||||||||||||||
| C58709 | Defer 6 month due clinical radiologic evidence cerebral infarct 30 day prior enrollment indicate code | Df6MoDuClRaEvCeIn30DyPrEnInCod | Code indicating whether the subject/participant's enrollment was deferred for at least 6 months due to clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Code indicating whether the subject/participant's enrollment was deferred for at least 6 months due to clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Was the patient previously deferred for >= 6 months due to clinical or radiologic evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 12:35:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDEFER | |||||||||||||||||||||||||||
| C58741 | Hyperbilirubinemia reason hyperhemolysis post transfusion hemoglobin drop indicate code | HypbilrRsnHyphemPoTrHbDpIndCod | Code indicating whether the subject/participant's hyperbilirubinemia is a result of hyperhemolysis or of a severe drop in hemoglobin following blood transfusion. | Code indicating whether the subject/participant's hyperbilirubinemia is a result of hyperhemolysis or of a severe drop in hemoglobin following blood transfusion. | Is the patient's hyperbilirubinemia a result of hyperhemolysis or a severe drop in hemoglobin post blood transfusion? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 12:16:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHYPHE | |||||||||||||||||||||||||||
| C58720 | Pain crisis information not available specify text | PnCrisInfoNotAvailSpecifyTxt | Text field for specifying why information about the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication was not available. | Text field for specifying why information about the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication was not available. | Specify why pain crises information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:18:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPCSP | ||||||||||||||||||||||||||||
| C58753 | Iron overload significant clinical evidence indicate code | IronOverloadSigClinEvdncIndCod | Code indicating whether the subject/participant has significant clinical evidence of iron overload. | Code indicating whether the subject/participant has significant clinical evidence of iron overload. | Does the patient have significant clinical evidence of iron overload (estimated hepatic iron content >= 10mg Fe/g liver dry weight)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:44:53.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCFEOV | |||||||||||||||||||||||||||
| C10740 | Echocardiogram left ventricle ejection fraction measurement | EchcrdLftVentEjctnFractnMeasr | Fraction of blood pumped out of the left ventricles with each heart beat measured with echocardiography | Fraction of blood pumped out of the left ventricles with each heart beat measured with echocardiography | Left ventricular ejection fraction | Numeric Values | Adult;Pediatric | Proposed | 3.00 | 2013-07-24 11:38:01.2 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
percent | ||||||||||||||||||||||||||||||||
| C58731 | Left ventricular ejection fraction perform date | LVEFPerformDate | Date on which the left ventricular ejection fraction (LVEF) test was performed | Date on which the left ventricular ejection fraction (LVEF) test was performed | Date LV ejection fraction performed | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:41:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLVEDT | |||||||||||||||||||||||||||||
| C58776 | Other clinical trial drug device investigational off-label past 3 month indicate code | OtClTrDrDvInOfLbPs3MoIndCode | Code indicating whether in the past 3 months the subject/participant participated in another clinical trial of an investigational or off-label use of a drug or device. | Code indicating whether in the past 3 months the subject/participant participated in another clinical trial of an investigational or off-label use of a drug or device. | Has the patient participated in another clinical trial in which the patient received an investigational or off-label use of a drug or device within 3 months of enrollment? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 09:49:49.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCLTR | |||||||||||||||||||||||||||
| C58791 | Donor meet institution protocol criteria indicate code | DonrMeetInstProtCritIndCode | Code indicating whether the donor meets institutional and protocol criteria for donation | Code indicating whether the donor meets institutional and protocol criteria for donation | Does the donor meet institutional and protocol-specified criteria for donation? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:02:29.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDCRIT | |||||||||||||||||||||||||||
| C58710 | MRI MRA evidence cerebral infarct date | MriMraEvidCerebInfrctDate | Date of cerebral MRI/MRA with evidence of a cerebral infarct. | Date of cerebral MRI/MRA with evidence of a cerebral infarct. | Record the date of the cerebral MRI/MRA with evidence of a cerebral infarct | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 12:47:10.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCMRIDT | |||||||||||||||||||||||||||||
| C58742 | Bilirubin most recent direct measurement | BlrubinMstRcntDrctMeasr | Measurement in milligrams per deciliter for the most recent direct measurement of bilirubin. | Measurement in milligrams per deciliter for the most recent direct measurement of bilirubin. | Direct bilirubin most recent value (mg/dL) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-07 13:01:37.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
0 | 9.9 | milligram per deciliter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCBILI | ||||||||||||||||||||||||||
| C58721 | Red blood cell transfusion multiple per year 12 month prior enrollment indicate code | RBCTrfnMltPrYr12MoPriEnrIndCod | Code indicating whether the subject/participant has received multiple packed red blood cell (RBC) transfusions per year for at least one year during the 12 months prior to enrollment. | Code indicating whether the subject/participant has received multiple packed red blood cell (RBC) transfusions per year for at least one year during the 12 months prior to enrollment. | Has the patient received >= 8 packed red blood cell (RBC) transfusions per year for >= 1 year in the 12 months before enrollment to prevent vaso-occlusive clinical complications (i.e. pain, stroke, and acute chest syndrome)? | 1;2;3 | Yes;No;Unavailable | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:26:21.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCRBC | |||||||||||||||||||||||||||
| C58754 | Liver biopsy performed indicate code | LiverBiopsyPerformIndicateCode | Code indicating whether a liver biopsy was performed. | Code indicating whether a liver biopsy was performed. | Was a liver biopsy performed? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:48:47.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLIVBX | |||||||||||||||||||||||||||
| C10744 | Echocardiogram left ventricle fractional shortening measurement | EchcrdgrmLftVentFractShrtMeasr | Measurement of the difference between end-diastolic and end-systolic dimensions of the left ventricle divided by end-diastolic dimension assessed with echocardiography. FS or Fractional Shortening in percentage = EDD minus ESD divided by EDD times 100, where EDD = LV End Diastolic Dimension and ESD = LV End Systolic Dimension. | Measurement of the difference between end-diastolic and end-systolic dimensions of the left ventricle divided by end-diastolic dimension assessed with echocardiography. | LV Shortening fraction | Numeric Values | Adult;Pediatric | Proposed | 3.00 | 2013-07-24 11:38:01.2 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
percent | ||||||||||||||||||||||||||||||||
| C58732 | Left ventricular shortening fraction perform date | LftVentShortFracPerfDate | Date on which the left ventricular shortening fraction test was performed. | Date on which the left ventricular shortening fraction test was performed. | Date LV shortening fraction performed | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:43:47.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSFDT | |||||||||||||||||||||||||||||
| C58777 | Pregnant breastfeed current indicate code | PregBreastfeetCurrentIndCode | Code indicating whether the subject/participant is currently pregnant or breastfeeding. | Code indicating whether the subject/participant is currently pregnant or breastfeeding. | Is the patient pregnant or breastfeeding? | 1;2;3 | Yes;No;Not Applicable | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 09:56:06.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPREG | |||||||||||||||||||||||||||
| C58792 | Donor have clinically significant hemoglobinopathy indicate code | DonrHavClinSigHmglobpthIndCode | Code indicating whether the donor has a clinically significant hemoglobinopathy. | Code indicating whether the donor has a clinically significant hemoglobinopathy. | Does the donor have a clinically significant hemoglobinopathy? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:36:00.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHEM | |||||||||||||||||||||||||||
| C58711 | MRI MRA evidence cerebral infarct stabilization repeat date | MriMraEviCerInfStabRptDate | Date on which a repeat MRI/MRA was performed which provided evidence of stabilization of the cerebral infarct. | Date on which a repeat MRI/MRA was performed which provided evidence of stabilization of the cerebral infarct. | Record the date of the repeat cerebral MRI/MRA with evidence of stabilization of the cerebral infarct | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 12:49:43.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCRMRDT | |||||||||||||||||||||||||||||
| C58743 | Direct bilirubin institutional upper limit normal age value | DirBlrbnInstULNAgeVal | Value of the institutional upper limit of normal (ULN) for the subject/participant's age for bilirubin measured directly. | Value of the institutional upper limit of normal (ULN) for the subject/participant's age for bilirubin measured directly. | Institutional ULN of direct bilirubin for age | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-07 00:00:00.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
0 | 9.9 | milligram per deciliter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCBILIU | ||||||||||||||||||||||||||
| C58722 | Red blood cell transfusion start date | RBCTransfusionStartDate | Date on which packed red blood cell (RBC) transfusion was begun. | Date on which packed red blood cell (RBC) transfusion was begun. | Start date of RBC transfusion | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:34:44.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCR1DT | |||||||||||||||||||||||||||||
| C58755 | Liver biopsy date | LiverBiopsyDate | Date on which liver biopsy was performed. | Date on which liver biopsy was performed. | Record date of liver biopsy | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:51:00.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLBXDT | |||||||||||||||||||||||||||||
| C18027 | Comment text | CmmntTxt | Provide any additional information that pertains to the question. | Provide any additional information that pertains to the question. | Comments | Alphanumeric | Adult;Pediatric | Proposed | 3.00 | 2013-07-16 14:01:43.01 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment | 4000 |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C58733 | Oxygen saturation measurement date | OxygenSaturationMeasrDate | Date on which the measurement of the subject/participant's oxygen saturation level was obtained. | Date on which the measurement of the subject/participant's oxygen saturation level was obtained. | Date O2 saturation obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:52:29.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCO2DT | |||||||||||||||||||||||||||||
| C58778 | Autoimmune disease prevent tolerate transplant indicate code | AutoimDzPrvntTolratTpltIndCode | Code indicating whether the subject/participant has an autoimmune disease that would prevent him or her from tolerating a transplant. | Code indicating whether the subject/participant has an autoimmune disease that would prevent him or her from tolerating a transplant. | Does the patient have a clinically significant, uncontrolled autoimmune disease requiring active medical management (immunosuppressive therapy or chemotherapy), which, in the judgment of the local Principal Investigator, indicates that the patient could not tolerate transplantation? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 10:33:42.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCAIMM | |||||||||||||||||||||||||||
| C58793 | Patient consent blood sample optional study specific research indicate code | PtCstBldSmpOptStySpfResIndCode | Code indicating whether the subject/participant consented to provide blood samples for optional study-specific research. | Code indicating whether the subject/participant consented to provide blood samples for optional study-specific research. | Did the patient give consent to provide blood samples for optional study-specific research? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:43:40.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMPL | |||||||||||||||||||||||||||
| C58712 | Neurological event information not available specify text | NeurEvntInfoNotAvailSpcfyTxt | Text field for specifying why information about a neurological event was not available. | Text field for specifying why information about a neurological event was not available. | Specify why neurological event information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 09:36:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Participant/Subject Identification, Eligibility, and Enrollment | 255 |
Free-Form Entry |
BMTCTN | Release 5.10 | 1507A (ENR) | HSCNEUSP |