| stfOperation
|
string
|
Operation
|
Defines the lifecycle operation of the Study Report (New, Replace, Append, Delete).
|
- new
- replace
- append
- delete
|
new
|
| fullReportTitle
|
string
|
Full Report Title
|
The Full name of the Report being submitted.
|
|
|
| reportNumber
|
string
|
Report Number
|
The Report number of the report being submitted.
|
|
|
| species
|
string
|
Species
|
The species that was used in the study.
|
- mouse
- rat
- hamster
- other-rodent
- rabbit
- dog
- non-human-primate
- other-non-rodent-mammal
- non-mammals
|
|
| routeOfAdministration
|
string
|
Route of Administration
|
The route of administration that was used in the study.
|
- oral
- intravenous
- intramuscular
- intraperitoneal
- subcutaneous
- inhalation
- topical
- other
|
|
| duration
|
string
|
Duration
|
The duration of the study.
|
|
|
| typeOfControl
|
string
|
Type of Control
|
The type of control used during the study.
|
- placebo
- no-treatment
- dose-response-without-placebo
- active-control-without-placebo
- external
|
|
| subjectMatter
|
string
|
Subject Matter
|
The subject matter for the specific study.
|
pre-clinical-study-report, legacy-clinical-study-report, synopsis, study-report-body, protocol-or-amendment, sample-case-report-form, iec-irb-consent-form-list, list-description-investigator-site, signatures-investigators, list-patients-with-batches, randomisation-scheme, audit-certificates-report, statistical-methods-interim-analysis-plan, inter-laboratory-standardisation-methods-quality-assurance, publications-based-on-study, publications-referenced-in-report, discontinued-patients, protocol-deviations, patients-excluded-from-efficacy-analysis, demographic-data, compliance-and-drug-concentration-data, individual-efficacy-response-data, adverse-event-listings, listing-individual-laboratory-measurements-by-patient, available-on-request, complete-patient-list, serious-adverse-event-patient-list, adverse-event-patient-list, abnormal-lab-values-patient-list, data-tabulation-dataset-legacy, data-tabulation-dataset-sdtm, data-tabulation-dataset-send, me="data-tabulation-dataset, data-tabulation-data-definition, data-listing-dataset, data-listing-data-definition, analysis-dataset-adam, analysis-dataset-legacy, e="analysis-dataset, analysis-program, analysis-data-definition, annotated-crf, ecg, image, subject-profiles, safety-report, antibacterial, special-pathogen, antiviral, iss, ise, pm-description
|
|
| docId
|
string
|
|
This field is not used for import.
|
|
|