Sub-Domain: general-data-protection-regulation-gdpr
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 |
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C60107 | Transfusion simple quantity text | TransfusionSimpleQuantityTxt | Text field for reporting the quantity of blood provided to the subject/participant during a simple (non-exchange) transfusion. | Text field for reporting the quantity of blood provided to the subject/participant during a simple (non-exchange) transfusion. | Simple (how much?) | Alphanumeric |
Specify unit of measurement. |
Adult;Pediatric | Core | 1.00 | 2021-01-14 15:01:08.0 | Acute Anemia | general-data-protection-regulation-gdpr | 50 |
Free-Form Entry |
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C60097 | Lactic acid dehydrogenase measurement unit of measure | LDHMeasrUOM | Unit of measurement for the measurement of the subject/participant's lactic acid dehydrogenase (LDH) | Unit of measurement for the measurement of the subject/participant's lactic acid dehydrogenase (LDH) | LDH Units | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 13:17:31.0 | Acute Anemia | general-data-protection-regulation-gdpr | 50 |
Free-Form Entry |
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C60108 | Anemia associated condition type | AnemiaAssocConditionTyp | Types of conditions associated with anemia with which the subject/participant presents. | Types of conditions associated with anemia with which the subject/participant presents. | Associated conditions – e.g., acute chest | Acute chest syndrome | Acute chest syndrome | Alphanumeric |
Select all that apply. |
Adult;Pediatric | Core | 1.00 | 2021-01-14 15:05:29.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Multiple Pre-Defined Values Selected |
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C60098 | Hydroxyurea receive indicator | HURcvInd | Indicator of whether the subject/participant is receiving hydroxyurea (HU). | Indicator of whether the subject/participant is receiving hydroxyurea (HU). | On HU? | No;Yes;Unknown | No;Yes;Unknown | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 13:20:17.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C60109 | Anemia associated condition type other text | AnemiaAssocConditionTypOTH | The free-text field related to "Anemia associated condition type" for specifying associated conditions not listed. | The free-text field related to "Anemia associated condition type" for specifying associated conditions not listed. | Other | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 15:05:29.0 | Acute Anemia | general-data-protection-regulation-gdpr | 255 |
Free-Form Entry |
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C60099 | Hydroxyurea dose postpone indicator | HUDosePostponeInd | Indicator of whether the administration of the hydroxyurea (HU) dose was postponed. | Indicator of whether the administration of the hydroxyurea (HU) dose was postponed. | Hydroxyurea doses held? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 14:32:57.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C60110 | Hemoglobin change from baseline grade | HgbChangFromBslnGrade | Grade of change in subject/participant's hemoglobin from steady-state baseline. | Grade of change in subject/participant's hemoglobin from steady-state baseline. | Change from baseline | Grade 1;Grade 2;Grade 3;Grade 4;Grade 5 | Grade 1 > 1gm/dl decrease from baseline;Grade 2 > 2gm/dl decrease from baseline;Grade 3 > 3gm/dl decrease from baseline or < 6gm/dl or transfusion indicated;Grade 4 > Life threatening consequences, urgent intervention needed;Grade 5 > Death | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 15:47:54.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
LB | HGB_LBTOX |
Lab Toxicity |
Toxicity |
What is the description of the toxicity? |
Use of this CDE on the Chronic Anemia form is not recommend if this result is already collected elsewhere in the clinical database (e.g., on an laboratory specific form). Data should not be double collected. |
LBTOX | Char | Record the description of the toxicity. |
LBOTX where LBTESTCD = "HGB" |
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C60100 | Hydroxyurea dose postpone duration text | HUDosePostponeDurTxt | Text field for recording the duration for which the administration of hydroxyurea (HU) to the subject/participant was postponed. | Text field for recording the duration for which the administration of hydroxyurea (HU) to the subject/participant was postponed. | Hydroxyurea how long? (weeks, months) | Alphanumeric |
Specify units. |
Adult;Pediatric | Core | 1.00 | 2021-01-14 14:34:55.0 | Acute Anemia | general-data-protection-regulation-gdpr | 25 |
Free-Form Entry |
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C60348 | Transfusion simple quantity unit of measure | TransfusionSimpleQuantityUOM | Unit of measure of the quantity of blood provided to the subject/participant during a simple (non-exchange) transfusion. | Unit of measure of the quantity of blood provided to the subject/participant during a simple (non-exchange) transfusion. | Simple (how much?) | Alphanumeric | Adult | Core | 1.00 | 2021-01-14 15:01:08.0 | Acute Anemia | general-data-protection-regulation-gdpr | 50 |
Free-Form Entry |
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C60101 | Anemia cause reason | AnemiaCauseRsn | Reason for or cause of the subject/participant's anemia. | Reason for or cause of the subject/participant's anemia. | Cause | Surgical;Blood Loss;Infection;Parvovirus Aplastic Crisis;Sequestration (splenic, hepatic);Myelosuppression;Hemolysis | Surgical;Blood Loss;Infection;Parvovirus Aplastic Crisis;Sequestration (splenic, hepatic);Myelosuppression;Hemolysis | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 14:38:44.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Multiple Pre-Defined Values Selected |
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C60349 | Hydroxyurea dose postpone duration unit of measure | HUDosePostponeDurUOM | Unit of measure for the duration for which the administration of hydroxyurea (HU) to the subject/participant was postponed. | Unit of measure for the duration for which the administration of hydroxyurea (HU) to the subject/participant was postponed. | Hydroxyurea how long? (weeks, months) | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 14:34:55.0 | Acute Anemia | general-data-protection-regulation-gdpr | 25 |
Free-Form Entry |
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C59968 | Platelet count value | PlateletCountVal | Value of the count of platelets in the subject/participant's complete blood cell (CBC) sample. | Value of the count of platelets in the subject/participant's complete blood cell (CBC) sample. | Platelet Count Value | Numeric Values | Adult;Pediatric | Core | 1.00 | 2020-09-01 13:36:15.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Free-Form Entry |
CIBMTR | n/a | Form 2031 revision 2 | 15: Platelets | ||||||||||||||||||||||||||||||
C60102 | Infection organism name | InfectionOrganismName | Name of the infectious organism present in the subject/participant. | Name of the infectious organism present in the subject/participant. | If Infection – Organism if known | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 14:47:18.0 | Acute Anemia | general-data-protection-regulation-gdpr | 100 |
Free-Form Entry |
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C60092 | Hemoglobin low value | HgbLowVal | Value of the lowest measurement of the subject/participant's hemoglobin. | Value of the lowest measurement of the subject/participant's hemoglobin. | Hemoglobin Nadir | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-01-14 13:00:29.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Free-Form Entry |
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C60103 | Infection viral titer text | InfectionViralTiterTxt | Text describing the viral titers performed for the infection present in the subject/participant. | Text describing the viral titers performed for the infection present in the subject/participant. | If Infection – viral titers | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 14:49:25.0 | Acute Anemia | general-data-protection-regulation-gdpr | 255 |
Free-Form Entry |
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C60093 | Reticulocyte count | ReticulocyteCt | Count of reticulocytes | Count of reticulocytes | Reticulocyte Count Value | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-01-14 13:06:05.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Free-Form Entry |
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C60104 | Transfusion required indicator | TransfusnRequirdInd | Indicator of whether the subject/participant requires a transfusion because of his or her anemia. | Indicator of whether the subject/participant requires a transfusion because of his or her anemia. | Transfusion required? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 14:52:13.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C60094 | Reticulocyte count unit of measure | ReticulocyteCtUOM | Unit of measure for the subject/participant's reticulocyte count as recorded using the data element "Reticulocyte count". | Unit of measure for the subject/participant's reticulocyte count as recorded using the data element "Reticulocyte count". | Reticulocyte Count Units | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 13:07:35.0 | Acute Anemia | general-data-protection-regulation-gdpr | 50 |
Free-Form Entry |
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C60105 | Transfusion exchange type indicator | TransfusionExchangeTypeInd | Indicator of whether the subject/participant required an exchange-type transfusion. | Indicator of whether the subject/participant required an exchange-type transfusion. | Exchange | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 14:55:27.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C60095 | Platelet count unit of measure | PlateletCtUOM | Unit of measure for the count of platelets. | Unit of measure for the count of platelets. | Platelet Count Units | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 13:12:42.0 | Acute Anemia | general-data-protection-regulation-gdpr | 50 |
Free-Form Entry |
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C60106 | Transfusion simple type indicator | TransfusionSimpleTypeInd | Indicator of whether the subject/participant required a simple-type transfusion. | Indicator of whether the subject/participant required a simple-type transfusion. | Simple | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 14:55:27.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C60096 | Lactic acid dehydrogenase measurement value | LDHMeasrVal | Value of the measurement of the subject/participants lactic acid dehydrogenase (LDH). | Value of the measurement of the subject/participants lactic acid dehydrogenase (LDH). | LDH Value | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-01-14 13:15:48.0 | Acute Anemia | general-data-protection-regulation-gdpr |
Free-Form Entry |