The eCTD summit

The codes needed to implement Regulated Product Submission (RPS) are here and can be found at the following location:
http://nciterms.nci.nih.gov/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C79148&bookmarktag=1

Unlike eCTD, where XML element names define your table of contents, coded terminology determines table of contents in a RPS submission.
The codes provided are only the table of contents sections for ICH’s Common Technical Document (CTD) and the US FDA’s regional table of contents.

US FDA’s food submissions content is pending. Codes for other countries or other product types within the United States have not developed for their respective table of contents.

The CTD codes provided are not perfect and are not complete.

Most of the attributes (e.g. manufacturer, study id; a.k.a. keywords in RPS speak) of the CTD, section1.11.4, Description: Multiple Module Information Amendment in the US FDA’s regional section and the study heading, mainly defined by ICH’s E3 specification are missing.

The FDA and NCI are working to update the code list.

The following are the list of study heading that where codes need to be created

• Legacy 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
• Randomisations 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
• Individual Subject Data Listing
• Data Tabulation
• Data Tabulation Dataset
• Data Tabulation Data Definition
• Data Listing
• Data Listing Dataset
• Data Listing Data Definition
• Analysis Datasets
• Analysis Dataset
• Analysis Program
• Analysis Data Definition
• Annotated CRF
• Annotated ECG waveform datasets
• Image files
• Subject Profile
• Safety Report
• Available on Request
• Integrated analysis of efficacy - integrated summary of efficacy report
• Integrated analysis of safety - integrated summary of safety report
• Antibacterial microbiology report
• Antiviral microbiology report
• Special pathogens (e.g, fungi, parasites, mycobacteria) and immune modulator reports
• Postmarketing periodic adverse event drug experience report description