Protocol Title
Item
Protocol Title
text
Site Number
Item
Site Number
integer
Subject ID
Item
Subject ID
integer
Visit Date
Item
Visit Date
date
CL Item
Visit (specification) (3)
Study Visit
Item
Specification of Visit
text
Completion/Early Termination
Item
Completion/Early Termination
boolean
Item
General Appearance
text
Code List
General Appearance
General Appearance
Item
General Appearance: If abnormal, please describe
text
Code List
General Appearance
HEENT
Item
HEENT: If abnormal, please describe
text
Item
HEENT: Change from Baseline
text
Code List
HEENT: Change from Baseline
Neck
Item
Neck: If abnormal, please describe
text
Item
Neck: Change from Baseline
text
Code List
Neck: Change from Baseline
Item
Chest and Lungs
text
Code List
Chest and Lungs
Chest and Lungs
Item
Chest and Lungs: If abnormal, please describe
text
Item
Chest and Lungs: Change from Baseline
text
Code List
Chest and Lungs: Change from Baseline
Cardiovascular
Item
Cardiovascular: If abnormal, please describe
text
Item
Cardiovascular: Change from Baseline
text
Code List
Cardiovascular: Change from Baseline
Abdomen
Item
Abdomen: If abnormal, please describe
text
Item
Abdomen: Change from Baseline
text
Code List
Abdomen: Change from Baseline
Genitourinary
Item
Genitourinary: If abnormal, please describe
text
Item
Genitourinary: Change from Baseline
text
Code List
Genitourinary: Change from Baseline
Rectal
Item
Rectal: If abnormal, please describe
text
Item
Rectal: Change from Baseline
text
Code List
Rectal: Change from Baseline
Item
Musculoskeletal
text
Code List
Musculoskeletal
Musculoskeletal
Item
Musculoskeletal: If abnormal, please describe
text
Item
Musculoskeletal: Change from Baseline
text
Code List
Musculoskeletal: Change from Baseline
Lymph Nodes
Item
Lymph Nodes: If abnormal, please describe
text
Item
Lymph Nodes: Change from Baseline
text
Code List
Lymph Nodes: Change from Baseline
Item
Extremities/Skin
text
Code List
Extremities/Skin
Extremities/Skin
Item
Extremities/Skin: If abnormal, please describe
text
Item
Extremities/Skin: Change from Baseline
text
Code List
Extremities/Skin: Change from Baseline
Neurological
Item
Neurological: If abnormal, please describe
text
Item
Neurological: Change from Baseline
text
Code List
Neurological: Change from Baseline
Other
Item
Other: Please specify
text
Other
Item
Other: If abnormal, please describe
text
Item
Other: Change from Baseline
text
Code List
Other: Change from Baseline
Clinician Signature
Item
Clinician Signature
text
Date Completed
Item
Date Completed
date
Clinician Printed Name
Item
Clinician Printed Name
text