study_design_edit

Name	study_design_edit.txt
JSON File Name	study_design_edit.json
Type	compound
Schema Version	3.37
Description	The optional study design edit template defines and annotates elements of a study that are optional when it is initially defined (e.g. weblinks, publications) and for which updates are available after the initial design is uploaded. Use the study_design_edit template to add additional information for a study after a study is defined in ImmPort. IF ANY OF THE FOLLOWING SECTIONS ARE NOT USED, THEY NEED TO BE DELETED FROM THE TEMPLATE PRIOR TO UPLOADING THE TEMPLATE: arm_2_subject, arm_or_cohort, inclusion_exclusion, planned_visit, study_2_condition_or_disease, study_2_protocol, study_categorization, study_data_release, study_file, study_image, study_link, study_personnel, or study_pubmed.
Download	⬇️ study_design_edit.xlsx ⬇️ study_design_edit.txt ⬇️ study_design_edit.json This top-level schema references companion files (e.g. study_design_edit.Datum.json) in the same json-templates folder — download the all_templates.zip to get them all together.

Reading this table: see How to read the template documentation for what Required / Conditionally required / Optional mean and how to read the Type & Constraints column.

study_categorization

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
Research Focus	Required	Text, max 50 characters Controlled vocabulary — value must be one of lk_research_focus JSON: researchFocus (enum)	A research focus for the study from the drop down list Please use the drop down list

study_2_condition_or_disease

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
Condition Reported	Required	Text, max 550 characters Preferred vocabulary — reported value is kept; a preferred term from lk_disease_condition is filled in when it matches JSON: conditionReported (enum)	The condition(s)/disease(s) that is (are) being researched or evaluated in the study. Please select condition or disease from the list provided if the condition or disease matches yours or enter a condition or disease if there is not an appropriate one provided. Values provided by the user are further checked against the pref mapping table lk_study_condition_pref_mappng.

study_data_release

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
Data Release Version	Required	Integer JSON: dataReleaseVersion (positive)	The version of the study data release. It is a positive integer. The version of the study data release. It is a positive integer.
Data Release Date	Required	Date (DD-MMM-YYYY) JSON: dataReleaseDate (date)	The date format is either dd-MMM-yy or dd-MMM-yyyy where day (dd) is one or two digits 1..31 appropriate to the month, month (MMM) is case-insensitive value (Jan, Feb, Mar, Apr, May, Jun, Jul, Aug, Sep, Oct, Nov, Dec), and year is either (yy) two digits, for example 05 means 2005, and 96 means 1996, or (yyyy) is four digit year, for example 2005. The release date for the given version (Data Release Version) study. The date format is either dd-MMM-yy or dd-MMM-yyyy.
Data Release Status	Required	Text, max 50 characters Controlled vocabulary — value must be one of lk_release_status JSON: dataReleaseStatus (enum)	The status of the data release for the study. Either it is the 'Initial' release or an 'Updated' release.

study_file

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
File Name	Required	Text, max 250 characters JSON: fileName (string)	If there are additional files (e.g. as data dictionaries, CRFs, custom formatted lab tests or assements) that should be linked to the study please indicate them in this block. Insert rows in the template to link additional files to the study. The file size name limit is 250 characters. For a given study, all file names for study_file must be unique. The name of the file, including file extension, that is to be linked to the study. The file size name limit is 250 characters. For a given study, all file names for study_file must be unique.
Description	Required	Text, max 4000 characters JSON: description (string)	A brief description of the file.
Study File Type	Required	Text, max 50 characters Controlled vocabulary — value must be one of lk_study_file_type JSON: studyFileType (enum)	Additional study data or study description are current preferred terms. Please choose from the drop down list.

study_image

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
Image Filename	Required	Text, max 250 characters JSON: imageFilename (string)	The name of the file containing the study image for the study. The file size name limit is 250 characters. For a given study, all file names for study_file must be unique.
Name	Required	Text, max 40 characters JSON: name (string)	The name or title for the study schematic.
Description	Optional	Text, max 4000 characters JSON: description (string)	A brief description of the study image file.

study_link

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
Name	Required	Text, max 500 characters JSON: name (string)	The name of the website to which the link refers.
Value	Required	Text, max 2000 characters JSON: value (string)	If this is a clinical trial, please include the clinicalTrial.gov URL. Define websites that are linked to the study. Insert rows in the template to define additional websites linked to the study.

study_pubmed

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
Pubmed ID	Required	Text, max 16 characters JSON: pubmedId (string)	The Pubmed or PubMedCentral identifier of an article that includes data from this study.
DOI	Optional	Text, max 100 characters JSON: doi (string)	Digital Object Identifier is a persistent identifier or handle used to uniquely identify an object. ImmPort DOIs are generated by DataCite (https://www.datacite.org/)
Title	Optional	Text, max 4000 characters JSON: title (string)	The title of an article that includes data from this study.
Journal	Optional	Text, max 250 characters JSON: journal (string)	The journal name that publishes an article that includes data from this study.
Year	Optional	Text, max 4 characters JSON: year (string)
Month	Optional	Text, max 12 characters JSON: month (string)
Issue	Optional	Text, max 20 characters JSON: issue (string)
Pages	Optional	Text, max 20 characters JSON: pages (string)
Authors	Optional	Text, max 4000 characters JSON: authors (string)

arm_or_cohort

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
User Defined ID	Required	Text, max 100 characters JSON: userDefinedId (string)	The study's arm(s) or cohort(s) group subjects by criteria relevant to the study (e.g. age, condition) and/or treatments or interventions. Insert rows in the template to define additional arms or cohorts linked to the study. The arm or cohort user defined ID is an identifier chosen by the data provider to refer to a subject grouping in the study document. This ID may be referenced by other data records (e.g. subjects). The user defined ID is not shared.
Name	Required	Text, max 126 characters JSON: name (string)	The arm or cohort name is not referenced by other data records. The arm or cohort name is an alternate identifier that is visible when the study is shared.
Description	Required	Text, max 4000 characters JSON: description (string)	The description should expand any abbreviations used in the arm or cohort name. For example for an observational study with a cohort whose name was "ADEH+", the description would be "Atopic dermatitis with eczema herpeticum".
Type Reported	Required	Text, max 40 characters Preferred vocabulary — reported value is kept; a preferred term from lk_arm_type is filled in when it matches JSON: typeReported (enum)	The drop down list provides the list of preferred study arm types derived from the National Cancer Institute Thesaurus (NCIT). For an interventional study, the type defines the treatment/control attributes of the arms. The attributes are selected from the values listed below (a study may have more than one arm of a given value). Clinical studies often use the following terms. Experimental - Arm for procedure or drug being evaluated. Active Comparator - arm receiving "standard of care" treatment. Placebo Comparator - arm receiving placebo treatment. Sham Comparator - arm receiving a sham procedure such as a urgery or a sham device. No Intervention - arm receiving neither "standard of care" treatment a placebo, or sham procedure or device. For an observational study, the type should be Observational - All arms are observing differences in cohorts Please select a preferred arm study type from the the drop down list. Terms are derived from the National Cancer Institute Thesaurus (NCIT). The study arm type is a preferred value and the table lk_arm_type_pref_mapping is also used to map the reported type to the drop down list (lk_arm_type).

arm_2_subject

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Subject ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a subject JSON: subjectId (string)	The subject ID can be either subject user defined ID or a subject accession.
Arm Or Cohort ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a arm_or_cohort JSON: armOrCohortId (string)	A subject may be assigned to a single arm within a study. To link a subject to more than one study's arm, create a new record for each subject to arm link. The arm or cohort ID can be either arm or cohort user defined ID or an arm or cohort accession.
Min Subject Age	Required	Number JSON: minSubjectAge (number)	The subject age at the outset of the study may be determined form one of several study milestones as indicated in the Age Event column. Please enter a number.
Max Subject Age	Optional	Number JSON: maxSubjectAge (number)	The subject age at the end of the study may be determined form one of several study milestones. Please enter a number.
Age Unit	Required	Text, max 25 characters Controlled vocabulary — value must be one of lk_time_unit JSON: ageUnit (enum)	A list of preferred terms is available.. The age unit must conform to the age unit assigned to the study. Please choose from the drop down list. The age unit must conform to the age unit assigned to the study.
Age Event	Required	Text, max 40 characters Controlled vocabulary — value must be one of lk_age_event JSON: ageEvent (enum)	A list of preferred terms is available. Please choose from the drop down list.
Age Event Specify	Conditionally required when Age Event = "other"	Text, max 50 characters JSON: ageEventSpecify (string)	This column supports providing study milestones for subject's age determination that ImmPort does not support. If "Age Event" = Other, this field specifies the age event (free text). Otherwise, leave this column blank.
Subject Phenotype	Optional	Text, max 200 characters JSON: subjectPhenotype (string)	The subject phenotype captures key aspects of the subject's disposition for the study. Enter a description of the subject.
Subject Location	Optional	Text, max 50 characters Controlled vocabulary — value must be one of lk_subject_location JSON: subjectLocation (enum)	A list of subject locations is available. Please choose from the drop down list.

planned_visit

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Optional	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
User Defined ID	Required	Text, max 100 characters JSON: userDefinedId (string)	The planned visit user defined ID is an identifier chosen by the data provider to refer to a protocol document. This ID may be referenced by other data records (e.g. biological samples). The user defined ID is not shared. Insert rows in the template to define additional planned visits linked to the study. The identifier should be unique to the ImmPort workspace to which the data will be uploaded.
Name	Required	Text, max 256 characters JSON: name (string)	the visit name should indicate the purpose of the visit (e.g. screening, assessment, inoculation, sample drawn). The visit name is not referenced by other data records. The visit name is an alternate identifier that is visible when the protocol is shared.
Order Number	Required	Integer JSON: orderNumber (positive)	This is a positive whole number value. The order of the visit within the study design schedule.
Min Start Day	Required	Number JSON: minStartDay (number)	This is a positive or negative numeric value. The minimum start day for a visit as defined in the study schedule.
Max Start Day	Optional	Number JSON: maxStartDay (number)	This is a positive or negative numeric value. If no value is entered, the maximum start day will be set equal to the minimum start day. The maximum start day for a visit as defined in the study schedule.
Start Rule	Optional	Text, max 256 characters JSON: startRule (string)	Enter a start rule only if it is more interesting than "subject has arrived for a scheduled visit".
End Rule	Optional	Text, max 256 characters JSON: endRule (string)	Enter an end rule only if it is more interesting than "subject has arrived for a scheduled visit".

study_personnel

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
User Defined ID	Required	Text, max 100 characters JSON: userDefinedId (string)	The personnel user defined ID is an identifier chosen by the data provider to refer to personnel who may be contacted for more details about the study document. If more than one study personnel record is to be defined, copy the block of rows from Study_Personnel_ID to Site_Name for each additional study personnel record. The identifier should be unique to the ImmPort workspace to which the data will be uploaded.
Honorific	Optional	Text, max 20 characters JSON: honorific (string)	Usually, the education achievement level of the person.
Last Name	Required	Text, max 40 characters JSON: lastName (string)	The last name of the study personnel being described.
First Name	Required	Text, max 40 characters JSON: firstName (string)	The first name of the study personnel being described.
Suffixes	Optional	Text, max 40 characters JSON: suffixes (string)	Suffixes that are part of the study personnel's name being described.
Organization	Required	Text, max 125 characters JSON: organization (string)	The organization with whom the study personnel being described is affiliated.
ORCID ID	Optional	Text, max 1000 characters JSON: orcidId (string)	ORCID (Open Researcher and Contributor Identification), a non-profit organization that promotes the use of its unique digital identifier to connect researchers with their science contributions over time and across changes of name, location and institutional affiliation. The NIH encourages use of this ID. See the link https://nexus.od.nih.gov/all/2019/08/05/linking-orcid-identifiers-to-era-profiles-to-streamline-application-processes-and-to-enhance-tracking-of-career-outcomes/.
Email	Required	Text, max 100 characters JSON: email (string)	Contact information of the study personnel being described.
Title In Study	Required	Text, max 100 characters JSON: titleInStudy (string)	The role the personnel play in the study as defined by the research team.
Role In Study	Required	Text, max 40 characters Controlled vocabulary — value must be one of lk_personnel_role JSON: roleInStudy (enum)	The ImmPort display will show the personnel listed as 'PI' in the study. Please use the drop down list.
Site Name	Required	Text, max 100 characters JSON: siteName (string)	Enter the site name if there is a need to further differentiate the affiliation of the study personnel form the Organization.

inclusion_exclusion

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
User Defined ID	Required	Text, max 100 characters JSON: userDefinedId (string)	The inclusion or exclusion user defined ID is an identifier chosen by the data provider to refer to a criterion used to determine whether a subject may be enrolled in a study. The identifier should be unique to the ImmPort workspace to which the data will be uploaded.
Criterion	Required	Text, max 750 characters JSON: criterion (string)	One or more criterion must be described to decide whether a subject may be enrolled in a study. The criterion describes the parameter used to decide if a subject may be enrolled in a study.
Criterion Category	Required	Text, max 40 characters Controlled vocabulary — value must be one of lk_criterion_category JSON: criterionCategory (enum)	The criterion category is selected from a preferred list of terms. There are two values to choose from: inclusion or exclusion.

study_2_protocol

Optional section — include it only if it applies to your study.

Template Column	Requirement	Type & Constraints	Description
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	The study ID can be either the study user defined ID or a study accession.
Protocol ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a protocol JSON: protocolId (string)	The protocol ID for the study. The identifier should be unique to the ImmPort workspace to which the data will be uploaded. It can be either a protocol user defined ID or an Accession.