basic_study_design
| Name | basic_study_design.txt |
| JSON File Name | basic_study_design.json |
| Type | compound |
| Schema Version | 3.37 |
| Description | The basic study design template defines and annotates key elements of a study including the purpose, subject grouping, schedule of events, personnel, and references (weblinks, publications). Use the study_design_edit template to add additional information for a study after a study is defined in ImmPort. The basic study design template consists of several sections or compound templates. Some compound templates are required: study, arm_or_cohort, inclusion_exclusion, planned_visit, study_2_condition_or_disease, study_2_protocol, study_categorization, study_personnel. Other compound templates are optional: study_file, study_link, and study_pubmed. |
| Download | ⬇️ basic_study_design.xlsx ⬇️ basic_study_design.txt ⬇️ basic_study_design.json This top-level schema references companion files (e.g. basic_study_design.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
Required section of the compound template.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| User Defined ID | Required | Text, max 150 characters JSON: userDefinedId (string) | The study user defined ID is an identifier chosen by the data provider to refer to a study design. This ID may be referenced by other data records (e.g. arm). The user defined ID is not shared. The identifier should be unique to the ImmPort workspace to which the data will be uploaded. |
| Brief Title | Required | Text, max 250 characters JSON: briefTitle (string) | The brief title will be displayed on ImmPort wherever the study is described. The brief title serves as a working title for a study. |
| Official Title | Required | Text, max 500 characters JSON: officialTitle (string) | The official study title is displayed on the ImmPort study detail page. The official study title may be the same as the brief title, but is often more descriptive. |
| Brief Description | Required | Text, max 4000 characters JSON: briefDescription (string) | A brief study description highlights the essential features of a study. Summarize the goals, methods and results of the study. |
| Description | Required | Text (long) JSON: description (string) | The detailed description can be formatted with html tags to improve legibility. Embedded new line characters should be removed. The detailed description supports a lengthy description of the goals and methods of the study. |
| Intervention Agent | Required | Text, max 1000 characters JSON: interventionAgent (string) | If a study is interventional or has an interventional component, a short descriptive name of the intervention agent is requested. IA brief description of the study's interventional component (e.g. influenza vaccine). |
| Endpoints | Required | Text (long) JSON: endpoints (string) | The endpoints can be formatted with html tags to improve legibility. Embedded new line characters should be removed. Endpoints include assessments, lab tests and assays that are part of a study design. |
| Sponsoring Organization | Required | Text, max 250 characters JSON: sponsoringOrganization (string) | The organization that provides funding and support for the study. |
| Age Unit | Required | Text, max 25 characters Controlled vocabulary — value must be one of lk_time_unit JSON: ageUnit (enum) | The unit of time used to describe the subject's age in the study. The unit of time for a subject must conform to this unit. |
| Actual Start Date | Optional | Date (DD-MMM-YYYY) JSON: actualStartDate (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 commencement time point of the study. The date format is either dd-MMM-yy or dd-MMM-yyyy. |
| Planned Public Release Date | Optional | Date (DD-MMM-YYYY) JSON: plannedPublicReleaseDate (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. Projected date for the release of the study to the public. The date format is either dd-MMM-yy or dd-MMM-yyyy. |
| Hypothesis | Optional | Text, max 4000 characters JSON: hypothesis (string) | The hypothesis can be formatted with html tags to improve legibility. Embedded new line characters should be removed. The explanatory proposition(s) being tested by the research study. |
| Objectives | Optional | Text (long) JSON: objectives (string) | The objectives can be formatted with html tags to improve legibility. Embedded new line characters should be removed. The goals of the research study. |
| Target Enrollment | Optional | Integer JSON: targetEnrollment (positive) | The number of subjects proposed to be enrolled in the study. |
| Minimum Age | Optional | Text, max 40 characters JSON: minimumAge (string) | The minimum age of subjects enrolled in the study. |
| Maximum Age | Optional | Text, max 40 characters JSON: maximumAge (string) | The maximum age of subjects enrolled in the study. |
study_categorization
Required section of the compound template.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| 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
Required section of the compound template.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| 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. |
arm_or_cohort
Required section of the compound template.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| 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. Use the study_design_edit template to add additional records after a study is defined in ImmPort. 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). |
study_personnel
Required section of the compound template.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| 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. Use the study_design_edit template to add additional records after a study is defined in ImmPort. 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/. |
| 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. Enter the site name if there is a need to further differentiate the affiliation of the study personnel from the Organization. |
planned_visit
Required section of the compound template.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| 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 planned visit. 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. Use the study_design_edit template to add additional records after a study is defined in ImmPort. 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". |
inclusion_exclusion
Required section of the compound template.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| 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. Use the study_design_edit template to add additional records after a study is defined in ImmPort. 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 form a preferred list of terms. There are two values to choose from: inclusion or exclusion. |
study_2_protocol
Required section of the compound template.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| Protocol ID | Required | Text, max 15 characters Reference — must already exist (in this package or the workspace) as a protocolJSON: protocolId (string) | The protocol ID for the study. Use the study_design_edit template to add additional records after a study is defined in ImmPort. |
study_file
Optional section — include it only if it applies to your study.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| 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 assessments) 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. Use the study_design_edit template to add additional records after a study is defined in ImmPort. 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 descriptions are current preferred terms. Please choose from the drop down list. |
study_link
Optional section — include it only if it applies to your study.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| Name | Required | Text, max 500 characters JSON: name (string) | The name of the website to which the link refers. Use the study_design_edit template to add additional records after a study is defined in ImmPort. |
| 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 |
|---|---|---|---|
| Pubmed ID | Required | Text, max 16 characters JSON: pubmedId (string) | The Pubmed or PubMedCentral identifier of an article that includes data from this study. Use the study_design_edit template to add additional records after a study is defined in ImmPort. |
| 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) | The article publication year. |
| Month | Optional | Text, max 12 characters JSON: month (string) | The article publication month. |
| Issue | Optional | Text, max 20 characters JSON: issue (string) | The journal's issue number. |
| Pages | Optional | Text, max 20 characters JSON: pages (string) | The journal's page number. |
| Authors | Optional | Text, max 4000 characters JSON: authors (string) | The article's authors. |
contract_grant
Optional section — include it only if it applies to your study.
| Template Column | Requirement | Type & Constraints | Description |
|---|---|---|---|
| External ID | Required | Text, max 200 characters JSON: externalId (string) | The ID assigned to this contract by the sponsoring organizaton. If it is a NIH Contract, please enter the project number assigned and available from NIH Reporter. Example: 1P01AI165072-01. |
| Category | Optional | Text, max 50 characters Controlled vocabulary — value must be one of lk_contract_category JSON: category (enum) | Category choices are NIH or Other |
| Name | Optional | Text, max 1000 characters JSON: name (string) | Name of the contract |
| Link | Required | Text, max 2000 characters JSON: link (string) | Add the URL for the link to the contract details. For example the link for a NIH contract 1K23HL125663-01, Metabolic derangements in ARDS is https://reporter.nih.gov/project-details/8804164 |