study_data_folder v. 1.0

Field Name Field Type Matching UI Field Description Acceptable Values Default Value
dataset string Dataset The type of dataset contained in the folder.
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, case-report-forms, available-on-request, complete-patient-list, serious-adverse-event-patient-list, adverse-event-patient-list, abnormal-lab-values-patient-list, data-tabulation-dataset, data-tabulation-data-definition, data-listing-dataset, data-listing-data-definition, analysis-dataset, analysis-program, analysis-data-definition, annotated-crf, ecg, image, subject-profiles, safety-report, antibacterial, special-pathogen, antiviral, iss, ise, pm-description