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/^(((\d{2}([13579][26]|[2468][048]|04|08)|(1600|2[048]00))([-\/])02(\6)29)|(\d{4}([-\/])((0[1-9]|1[012])(\9)(0[1-9]|1\d|2[0-8])|((0[13-9]|1[012])(\9)(29|30))|((0[13578]|1[02])(\9)31)))) (\d|[0-1]\d|[2][0-3]):[0-5]\d$/
/^((29([-\/])02\3(\d{2}([13579][26]|[2468][048]|04|08)|(1600|2[048]00)))|((((0[1-9]|1\d|2[0-8])([-\/])(0[1-9]|1[012]))|((29|30)([-\/])(0[13-9]|1[012]))|(31([-\/])(0[13578]|1[02])))(\11|\15|\18)\d{4})) (\d|[0-1]\d|[2][0-3])(:[0-5]\d){2}$/
/^((02([-\/])29\3(\d{2}([13579][26]|[2468][048]|04|08)|(1600|2[048]00)))|((((0[1-9]|1[012])([-\/])(0[1-9]|1\d|2[0-8]))|((0[13-9]|1[012])([-\/])(29|30))|((0[13578]|1[02])([-\/])31))(\11|\15|\19)\d{4})) (\d|[0-1]\d|[2][0-3])(:[0-5]\d){2}$/
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Repeating InstrumentsPID 12
My Projects Project Home Project Setup Online Designer Data Dictionary Codebook

The Codebook is a human-readable, read-only version of the project's Data Dictionary and serves as a quick reference for viewing the attributes of any given field in the project without having to download and interpret the Data Dictionary. Note: Checkbox fields have their coded values displayed both in the format defined by users in the Online Designer/Data Dictionary as well as in the extended format seen in data imports and exports (i.e., field___code).

Data Dictionary Codebook 04/12/2025 12:23am
# Variable / Field Name Field Label
Field Note
 Field Attributes (Field Type, Validation, Choices, Calculations, etc.)
Instrument:Demographics(demographics)
1 [record_id] Study ID text
2 [first_name] First Name text, Identifier
3 [last_name] Last Name text, Identifier
4 [gender] Gender radio
0Female
1Male
2Other
3Prefer not to say
5 [notes] Notes notes
6 [demographics_complete]
Section Header: Form Status
Complete? 		dropdown
0Incomplete
1Unverified
2Complete
Instrument:Medications(medications)
7 [medication_name] Medication name text
8 [dosage] Dosage
mg
 text (number)
9 [medications_complete]
Section Header: Form Status
Complete? 		dropdown
0Incomplete
1Unverified
2Complete
Instrument:Family Members(family_members)
10 [family_member]
Section Header: Family member information
Name of family member 		text
11 [relation_to_patient] Relation to patient dropdown
1Sibling
2Spouse
3Parent
4Child very long choice right here that is long
5Other
12 [age_of_family_member] Age of family member text (integer)
13 [family_members_complete]
Section Header: Form Status
Complete? 		dropdown
0Incomplete
1Unverified
2Complete
Instrument:Visits(visits)
14 [visit_date] Date text (date_mdy)
Field Annotation: @TODAY
15 [weight] Weight text (number)
16 [other_visit_data] Other data notes
17 [visits_complete]
Section Header: Form Status
Complete? 		dropdown
0Incomplete
1Unverified
2Complete
Instrument:Adverse Events(adverse_events)
18 [aeyn] Were any adverse events experienced?
Indicate if the subject experienced any adverse events.
 radio
0No
1Yes
19 [aespid]
Show the field ONLY if:
[aeyn] = "1"
AE Identifier
Record unique identifier for each adverse event for this subject.Number sequence for all following forms should not duplicate existing numbers for the subject.
 text
20 [aeterm]
Show the field ONLY if:
[aeyn] = "1"
What is the adverse event term?
Record only one diagnosis, sign or symptom per form (e.g., nausea and vomiting should not be recorded in the same entry, but as two separate entries). See eCRF completion instruction for more information.
 text
21 [aeoccur]
Show the field ONLY if:
[aeyn] = "1"
Does the subject have (specific adverse event)?
Please indicate if (specific adverse event) has occurred /is occurring by checking Yes or No.
 radio
0No
1Yes
22 [aestdat]
Show the field ONLY if:
[aeyn] = "1"
What is the date the adverse event started?
Record the start date of the adverse event using the MM-DD-YYYY format.
 text (date_mdy)
23 [aesttim]
Show the field ONLY if:
[aeyn] = "1"
At what time did the adverse event start?
If appropriate, record the time the AE started using the HH:MM (24-hour clock) format.
 text (time)
24 [aeongo]
Show the field ONLY if:
[aeyn] = "1"
Is the adverse event still ongoing?
Select one.
 radio
0No
1Yes
25 [aeendat]
Show the field ONLY if:
[aeongo] = "0"
What date did the adverse event end?
Record the end date of the adverse event using the MM-DD-YYYY format.
 text (date_mdy)
26 [aeentim]
Show the field ONLY if:
[aeongo] = "0"
At what time did the adverse event end?
If appropriate, record the time the AE ended using the HH:MM (24-hour clock) format.
 text (time)
27 [aesev]
Show the field ONLY if:
[aeyn] = "1"
What was the severity of the adverse event?
The reporting physician/healthcare professional will assess the severity of the event using the sponsor-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported Adverse Event to similar type events observed in clinical practice. Severity is not equivalent to seriousness.
 radio
1Mild
2Moderate
3Severe
28 [aetoxgr]
Show the field ONLY if:
[aeyn] = "1"
What is the toxicity grade of the adverse event?
Severity CTCAE GradeThe reporting physician/healthcare professional will assess the severity of the adverse event using the toxicity grades.
 radio
1Grade 1
2Grade 2
3Grade 3
4Grade 4
5Grade 5
29 [aeser]
Show the field ONLY if:
[aeyn] = "1"
Is the adverse event serious?
Assess if an adverse event should be classified as serious based on the serious criteria defined in the protocol.
 radio
0No
1Yes
30 [aescong]
Show the field ONLY if:
[aeser] = "1"
Is the adverse event associated with a congenital anomaly or birth defect?
Record whether the serious adverse event was associated with congenital anomaly or birth defect.
 radio
0No
1Yes
31 [aesdisab]
Show the field ONLY if:
[aeser] = "1"
Did the adverse event result in Persistent or significant disability or incapacity?
Record whether the serious adverse event resulted in a persistent or significant disability or incapacity.
 radio
0No
1Yes
32 [aesdth]
Show the field ONLY if:
[aeser] = "1"
Did the adverse event result in death?
Record whether the serious adverse event resulted in death.
 radio
0No
1Yes
33 [aeshosp]
Show the field ONLY if:
[aeser] = "1"
Did the adverse event result in initial or prolonged hospitalization for the subject?
Record whether the serious adverse event resulted in an initial or prolonged hospitalization.
 radio
0No
1Yes
34 [aeslife]
Show the field ONLY if:
[aeser] = "1"
Is the adverse event Life Threatening?
Record whether the serious adverse event is life threatening.
 radio
0No
1Yes
35 [aesmie]
Show the field ONLY if:
[aeser] = "1"
Is the adverse event a medically important event not covered by other ?serious? criteria?
Record whether the serious adverse event is an important medical event, which may be defined in the protocol or in the Investigator Brochure.
 radio
0No
1Yes
36 [aerel]
Show the field ONLY if:
[aeyn] = "1"
Is this event related to study treatment?
Indicate if the cause of the adverse event is related to the study treatment and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, and/or other interventions).
 radio
1Definitely
2Probably
3Possibly
4Not Related
37 [aeacn]
Show the field ONLY if:
[aeyn] = "1"
What action was taken with study treatment?
Record changes made to the study treatment resulting from the adverse event.
 radio
1Dose Increased
2Dose Not Changed
3Dose Reduced
4Drug Interrupted
5Drug Withdrawn
6Not Applicable
99Unknown
38 [aeacnoth]
Show the field ONLY if:
[aeyn] = "1"
What other action was taken in response to this adverse event?
Record all action(s) taken resulting from the adverse event.
 notes
39 [aeout]
Show the field ONLY if:
[aeyn] = "1"
What was the outcome of this adverse event?
Record the appropriate outcome of the event in relation to the subject's status.
 radio
1Fatal
2Not recovered / Not resolved
3Recovered / Resolved
4Recovered / Resolved with sequelae
5Recovering / Resolving
99Unknown
40 [aedis]
Show the field ONLY if:
[aeyn] = "1"
Did the adverse event cause the subject to be discontinued from the study?
Record if the AE caused the subject to discontinue from the study.
 radio
0No
1Yes
41 [adverse_events_complete]
Section Header: Form Status
Complete? 		dropdown
0Incomplete
1Unverified
2Complete
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