study_design_edit
| Name | study_design_edit.txt |
| Type | compound |
| Schema Version | 3.36 |
| 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. |
study_categorization
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| Research Focus | True | A research focus for the study from the drop down list |
study_2_condition_or_disease
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| 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. |
study_data_release
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| Data Release Version | True | The version of the study data release. It is a positive integer. |
| Data Release Date | True | 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. |
| Data Release Status | True | The status of the data release for the study. Either it is the 'Initial' release or an 'Updated' release. |
study_file
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| File Name | True | 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. |
| Description | True | A brief description of the file. |
| Study File Type | True | Additional study data or study description are current preferred terms. |
study_image
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| Image Filename | True | 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 | True | The name or title for the study schematic. |
| Description | False | A brief description of the study image file. |
study_link
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| Name | True | The name of the website to which the link refers. |
| Value | True | If this is a clinical trial, please include the clinicalTrial.gov URL. |
study_pubmed
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| Pubmed ID | True | The Pubmed or PubMedCentral identifier of an article that includes data from this study. |
| 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 | |
| Month | False | |
| Issue | False | |
| Pages | False | |
| Authors | False |
arm_or_cohort
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| 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. |
| 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 |
arm_2_subject
| Template Column | Required | Description |
|---|---|---|
| Subject ID | True | The subject ID can be either subject user defined ID or a subject accession. |
| Arm Or Cohort ID | True | 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. |
| Min Subject Age | True | 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. |
| Max Subject Age | False | The subject age at the end of the study may be determined form one of several study milestones. |
| Age Unit | True | A list of preferred terms is available.. The age unit must conform to the age unit assigned to the study. |
| Age Event | True | A list of preferred terms is available. |
| Age Event Specify | False | This column supports providing study milestones for subject's age determination that ImmPort does not support. |
| Subject Phenotype | False | The subject phenotype captures key aspects of the subject's disposition for the study. |
| Subject Location | False | A list of subject locations is available. |
planned_visit
| Template Column | Required | Description |
|---|---|---|
| Study ID | False | The study ID can be either the study user defined ID or a study accession. |
| User Defined ID | True | 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. |
| 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". |
study_personnel
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| 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. |
| 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/. |
| 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. |
inclusion_exclusion
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| 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. |
| 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 from a preferred list of terms. |
study_2_protocol
| Template Column | Required | Description |
|---|---|---|
| Study ID | True | The study ID can be either the study user defined ID or a study accession. |
| Protocol ID | True | The protocol ID for the study. |