CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Assessments and Examinations
CRF: Physical Exam

9 results.
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
C00023 Hand preference type HandPrefTyp Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. Hand preference Left hand;Right hand;Both hands;Unknown Left hand;Right hand;Both hands;Unknown Alphanumeric

Choose one - the hand which the participant/subject uses predominantly, not necessarily the hand the participant/subject writes with exclusively

No references available Adult;Pediatric Proposed 3.00 2013-07-25 08:54:08.2 Physical Exam Assessments and Examinations Physical Examinations

Single Pre-Defined Value Selected

DeBaun Forms
C00312 Body system category BodySysCat Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Body System Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify:;Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify:;Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: Alphanumeric

Each body system is pre-populated on the case report form.

Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf Adult;Pediatric Proposed 3.00 2013-07-25 08:54:08.2 Physical Exam Assessments and Examinations Physical Examinations

Single Pre-Defined Value Selected

DeBaun Forms
C01010 Physical exam date and time PhysExamDateTime Date (and time if applicable and known) physical exam was performed Date (and time if applicable and known) physical exam was performed Date of Exam Date or Date & Time

Record the date(and time) the physical exam was performed. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database.

No references available Adult;Pediatric Proposed 3.00 2013-08-28 16:08:00.453 Physical Exam Assessments and Examinations Physical Examinations

Free-Form Entry

C01012 Physical exam body system result type PhysExamBodySysResltTyp Assessment result of each body system examined Assessment result of each body system examined Result Abnormal;Normal;Not assessed Abnormal;Normal;Not assessed Alphanumeric

Choose one. Indicate whether each body system examined had any abnormal findings.

No references available Adult;Pediatric Proposed 3.00 2013-07-25 08:54:08.2 Physical Exam Assessments and Examinations Physical Examinations

Single Pre-Defined Value Selected

2821383
C01013 Physical exam description text PhysExamDescripTxt Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Describe Abnormality or Comment if Body System is Not Examined Alphanumeric

Provide a description of each abnormal result found during the physical exam, or provide an explanation of why the body system was not examined. See the data dictionary for additional information on coding the abnormality using the Systemized Nomenclature of Medicine-Clinical Terms(SNOMED CT).

SNOMED CT CODES - Problem List (http://www.nlm.nih.gov/research/umls/Snomed/core_subset.html) Adult;Pediatric Proposed 3.00 2013-07-25 08:54:08.2 Physical Exam Assessments and Examinations Physical Examinations 255

Free-Form Entry

DeBaun Forms
C01014 Physical exam abnormality significance type PhysExamAbnrmlySignfcnceTyp An indication if the physical exam abnormality in a specific body system is clinically significant An indication if the physical exam abnormality in a specific body system is clinically significant If Abnormality, Clinically Significant? Clinically Significant;Not Clinically Significant;Clinically Significant;Not Clinically Significant Clinically Significant;Not Clinically Significant;Clinically Significant;Not Clinically Significant Alphanumeric

Choose one. If the body system had an abnormal finding, record whether the abnormality is Clinically Significant. Any Abnormal, Clinically Significant finding at screening should be recorded on the Medical History as well.

No references available Adult;Pediatric Proposed 3.00 2013-07-25 08:54:08.2 Physical Exam Assessments and Examinations Physical Examinations

Single Pre-Defined Value Selected

C01015 Physical exam performed indicator PhysExamPerfrmdInd Indicator of whether a physical exam was performed on the participant/subject Indicator of whether a physical exam was performed on the participant/subject Was a physical exam performed on the participant/subject? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. Specify whether or not a physical exam was performed on the participant/subject.

No references available Adult;Pediatric Proposed 3.00 2013-07-25 08:54:08.2 Physical Exam Assessments and Examinations Physical Examinations

Single Pre-Defined Value Selected

C01028 Physical exam condition SNOMED CT code PhysExamCondSNOMEDCTcode Medical condition/disease found during the physical examination of the participant/subject. Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) Medical condition/disease found during the physical examination of the participant/subject. Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) Describe Abnormality or Comment if Body System is Not Examined Alphanumeric

Code the description of each abnormal result found during the physical exam using the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT).

SNOMED CT CODES - Problem List (http://www.nlm.nih.gov/research/umls/Snomed/core_subset.html) Adult;Pediatric Proposed 3.00 2013-08-28 16:08:00.453 Physical Exam Assessments and Examinations Physical Examinations 255

Free-Form Entry

C18666 Body system other text BodySysOTH The free-text field related to 'Body system category' specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured Free-text category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Other, specify Alphanumeric

Each body system is pre-populated on the case report form.

Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf Adult;Pediatric Proposed 1.00 2014-05-27 13:34:46.0 Physical Exam Assessments and Examinations Physical Examinations 4000

Free-Form Entry

DeBaun Forms
9 results.
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