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basic_study_design

Name basic_study_design.txt
Type compound
Schema Version 3.34
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.

study

Template ColumnRequiredDescription
User Defined ID True 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.
Brief Title True The brief title will be displayed on ImmPort wherever the study is described.
Official Title True The official study title is displayed on the ImmPort study detail page.
Brief Description True A brief study description highlights the essential features of a study.
Description True The detailed description can be formatted with html tags to improve legibility. Embedded new line characters should be removed.
Intervention Agent True If a study is interventional or has an interventional component, a short descriptive name of the intervention agent is requested.
Endpoints True The endpoints can be formatted with html tags to improve legibility. Embedded new line characters should be removed.
Sponsoring Organization True The organization that provides funding and support for the study.
Age Unit True 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 False 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.
Hypothesis False The hypothesis can be formatted with html tags to improve legibility. Embedded new line characters should be removed.
Objectives False The objectives can be formatted with html tags to improve legibility. Embedded new line characters should be removed.
Target Enrollment False The number of subjects proposed to be enrolled in the study.
Minimum Age False The minimum age of subjects enrolled in the study.
Maximum Age False The maximum age of subjects enrolled in the study.

study_categorization

Template ColumnRequiredDescription
Research Focus True A research focus for the study from the drop down list

study_2_condition_or_disease

Template ColumnRequiredDescription
Condition Reported True 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

Template ColumnRequiredDescription
User Defined ID True 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.
Name True The arm or cohort name is not referenced by other data records.
Description True 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 True 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

study_personnel

Template ColumnRequiredDescription
User Defined ID True 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.
Honorific False Usually, the education achievement level of the person.
Last Name True The last name of the study personnel being described.
First Name True The first name of the study personnel being described.
Suffixes False Suffixes that are part of the study personnel's name being described.
Organization True The organization with whom the study personnel being described is affiliated.
ORCID ID False 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 True Contact information of the study personnel being described.
Title In Study True The role the personnel play in the study as defined by the research team.
Role In Study True The ImmPort display will show the personnel listed as 'PI' in the study.
Site Name True Enter the site name if there is a need to further differentiate the affiliation of the study personnel form the Organization.

planned_visit

Template ColumnRequiredDescription
User Defined ID True 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.
Name True 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.
Order Number True This is a positive whole number value.
Min Start Day True This is a positive or negative numeric value.
Max Start Day False 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.
Start Rule False Enter a start rule only if it is more interesting than "subject has arrived for a scheduled visit".
End Rule False Enter an end rule only if it is more interesting than "subject has arrived for a scheduled visit".

inclusion_exclusion

Template ColumnRequiredDescription
User Defined ID True 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.
Criterion True One or more criterion must be described to decide whether a subject may be enrolled in a study.
Criterion Category True The criterion category is selected form a preferred list of terms.

study_2_protocol

Template ColumnRequiredDescription
Protocol ID True 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

Template ColumnRequiredDescription
File Name True 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.
Description True A brief description of the file.
Study File Type True Additional study data or study descriptions are current preferred terms.
Template ColumnRequiredDescription
Name True 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 True If this is a clinical trial, please include the clinicalTrial.gov URL.

study_pubmed

Template ColumnRequiredDescription
Pubmed ID True 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 False 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 False The title of an article that includes data from this study.
Journal False The journal name that publishes an article that includes data from this study.
Year False The article publication year.
Month False The article publication month.
Issue False The journal's issue number.
Pages False The journal's page number.
Authors False The article's authors.
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