H/ICH/eCTD/US/3.2/Heading
The Electronic Common Technical Document (eCTD) standard format is used by regulatory agencies for data and file submitted electronically [1].
The standard format provides a structure to organize, tag, and link submitted datasets and documents.
The module ectd includes functions for working with the eCTD format.
The Comprehensive Table of Contents Headings and Hierarchy (CTOC) by FDA
The current FDA supporting version of eCTD standard is 3.2.2 and the newest testing version is 4.0 with base implementation package v1.5 [2].
FDA has released guidance on heading hierarchy of eCTD [3],[4].
The ectd module provides functions for listing and searching within the heading hierarchy.
Disclaimer: this module is shared for quick searching and preview headings with the intention to be helpful. The author can not guarantee the correctness of the heading. Please notify the author if any typos were found.
Module 1
To view CTOC of Module 1:
from mtbp3.health import ectd
ctoc = ectd.ctoc_by_fda()
print('\n'.join(ctoc.show_ctoc_tree(1)))
1 Module 1 Administrative information
├── 1.1 Forms [form-type]
├── 1.2 Cover letters
├── 1.3 Administrative information
│ ├── 1.3.1 Contact/sponsor/applicant information
│ │ ├── 1.3.1.1 Change of address or corporate name
│ │ ├── 1.3.1.2 Change in contact/agent
│ │ ├── 1.3.1.3 Change in sponsor
│ │ ├── 1.3.1.4 Transfer of obligation
│ │ └── 1.3.1.5 Change in ownership of an application or reissuance of license
│ ├── 1.3.2 Field copy certification
│ ├── 1.3.3 Debarment certification
│ ├── 1.3.4 Financial certification and disclosure
│ ├── 1.3.5 Patent and exclusivity
│ │ ├── 1.3.5.1 Patent information
│ │ ├── 1.3.5.2 Patent certification
│ │ └── 1.3.5.3 Exclusivity claim
│ └── 1.3.6 Tropical disease priority review voucher
├── 1.4 References
│ ├── 1.4.1 Letter of authorization
│ ├── 1.4.2 Statement of right of reference
│ ├── 1.4.3 List of authorized persons to incorporate by reference
│ └── 1.4.4 Cross-reference to previously submitted information
├── 1.5 Application status
│ ├── 1.5.1 Withdrawal of an IND
│ ├── 1.5.2 Inactivation request
│ ├── 1.5.3 Reactivation request
│ ├── 1.5.4 Reinstatement request
│ ├── 1.5.5 Withdrawal of an unapproved BLA, NDA, ANDA, or Supplement
│ ├── 1.5.6 Withdrawal of listed drug
│ └── 1.5.7 Withdrawal of approval of an application or revocation of license
├── 1.6 Meetings
│ ├── 1.6.1 Meeting request
│ ├── 1.6.2 Meeting background materials
│ └── 1.6.3 Correspondence regarding meetings
├── 1.7 Fast track
│ ├── 1.7.1 Fast track designation request
│ ├── 1.7.2 Fast track designation withdrawal request
│ ├── 1.7.3 Rolling review request
│ └── 1.7.4 Correspondence regarding fast track/rolling review
├── 1.8 Special protocol assessment request
│ ├── 1.8.1 Clinical study
│ ├── 1.8.2 Carcinogenicity study
│ ├── 1.8.3 Stability study
│ └── 1.8.4 Animal efficacy study for approval under the animal rule
├── 1.9 Pediatric administrative information
│ ├── 1.9.1 Request for waiver of pediatric studies
│ ├── 1.9.2 Request for deferral of pediatric studies
│ ├── 1.9.3 Request for pediatric exclusivity determination
│ ├── 1.9.4 Proposed pediatric study request and amendments
│ ├── 1.9.5 Proposal for written agreement (no longer applicable)
│ └── 1.9.6 Other correspondence regarding pediatric exclusivity or study plans
├── 1.10 Dispute resolution
│ ├── 1.10.1 Request for dispute resolution
│ └── 1.10.2 Correspondence related to dispute resolution
├── 1.11 Information amendment: Information not covered under modules 2 to 5
│ ├── 1.11.1 Quality information amendment
│ ├── 1.11.2 Nonclinical information amendment
│ ├── 1.11.3 Clinical information amendment
│ └── 1.11.4 Multiple module information amendment
├── 1.12 Other correspondence
│ ├── 1.12.1 Pre IND correspondence
│ ├── 1.12.2 Request to charge for clinical trial
│ ├── 1.12.3 Request to charge for expanded access
│ ├── 1.12.4 Request for comments and advice
│ ├── 1.12.5 Request for a waiver
│ ├── 1.12.6 Exception from informed consent for emergency research
│ ├── 1.12.7 Public disclosure statement for exception from informed consent for emergency research
│ ├── 1.12.8 Correspondence regarding exception from informed consent for emergency research
│ ├── 1.12.9 Notification of discontinuation of clinical trial
│ ├── 1.12.10 Generic drug enforcement act statement
│ ├── 1.12.11 ANDA basis for submission statement
│ ├── 1.12.12 Comparison of generic drug and reference listed drug
│ ├── 1.12.13 Request for waiver for in vivo studies
│ ├── 1.12.14 Environmental analysis
│ ├── 1.12.15 Request for waiver of in vivo bioavailability studies
│ ├── 1.12.16 Field alert reports
│ └── 1.12.17 Orphan drug designation
├── 1.13 Annual report
│ ├── 1.13.1 Summary for nonclinical studies
│ ├── 1.13.2 Summary of clinical pharmacology information
│ ├── 1.13.3 Summary of safety information
│ ├── 1.13.4 Summary of labeling changes
│ ├── 1.13.5 Summary of manufacturing changes
│ ├── 1.13.6 Summary of microbiological changes
│ ├── 1.13.7 Summary of other significant new information
│ ├── 1.13.8 Individual study information
│ ├── 1.13.9 General investigational plan
│ ├── 1.13.10 Foreign marketing
│ ├── 1.13.11 Distribution data
│ ├── 1.13.12 Status of postmarketing study commitments and requirements
│ ├── 1.13.13 Status of other postmarketing studies and requirements
│ ├── 1.13.14 Log of outstanding regulatory business
│ └── 1.13.15 Development safety update report (DSUR)
├── 1.14 Labeling
│ ├── 1.14.1 Draft labeling
│ │ ├── 1.14.1.1 Draft carton and container labels
│ │ ├── 1.14.1.2 Annotated draft labeling text
│ │ ├── 1.14.1.3 Draft labeling text
│ │ ├── 1.14.1.4 Label comprehension studies
│ │ └── 1.14.1.5 Labeling history
│ ├── 1.14.2 Final labeling
│ │ ├── 1.14.2.1 Final carton or container labels
│ │ ├── 1.14.2.2 Final package insert (package inserts, patient information, medication guides)
│ │ └── 1.14.2.3 Final labeling text
│ ├── 1.14.3 Listed drug labeling
│ │ ├── 1.14.3.1 Annotated comparison with listed drug
│ │ ├── 1.14.3.2 Approved labeling text for listed drug
│ │ └── 1.14.3.3 Labeling text for reference listed drug
│ ├── 1.14.4 Investigational drug labeling
│ │ ├── 1.14.4.1 Investigational brochure
│ │ └── 1.14.4.2 Investigational drug labeling
│ ├── 1.14.5 Foreign labeling
│ └── 1.14.6 Product labeling for 2253 submissions
├── 1.15 Promotional material [promotional-material-audience-type]
│ ├── 1.15.1 Correspondence relating to promotional materials
│ │ ├── 1.15.1.1 Request for advisory comments on launch materials
│ │ ├── 1.15.1.2 Request for advisory comments on non-launch materials
│ │ ├── 1.15.1.3 Presubmission of launch promotional materials for accelerated approval products
│ │ ├── 1.15.1.4 Presubmission of non-launch promotional materials for accelerated approval products
│ │ ├── 1.15.1.5 Pre-dissemination review of television ads
│ │ ├── 1.15.1.6 Response to untitled letter or warning letter
│ │ ├── 1.15.1.7 Response to information request
│ │ ├── 1.15.1.8 Correspondence accompanying materials previously missing or rejected
│ │ ├── 1.15.1.9 Withdrawal request
│ │ ├── 1.15.1.10 Submission of annotated references
│ │ └── 1.15.1.11 General correspondence
│ └── 1.15.2 Materials attribute = [promotional-material-doc-type]
│ └── 1.15.2.1 Material [promotional-material-type, material-id, issue- date]
│ ├── 1.15.2.1.1 Clean version
│ ├── 1.15.2.1.2 Annotated version
│ ├── 1.15.2.1.3 Annotated labeling version
│ └── 1.15.2.1.4 Annotated references
├── 1.16 Risk management plan
│ ├── 1.16.1 Risk Management (Non-REMS)
│ └── 1.16.2 Risk Evaluation and Mitigation Strategy (REMS)
│ ├── 1.16.2.1 Final REMS
│ ├── 1.16.2.2 Draft REMS
│ ├── 1.16.2.3 REMS Assessment
│ ├── 1.16.2.4 REMS Assessment Methodology
│ ├── 1.16.2.5 REMS Correspondence
│ └── 1.16.2.6 REMS Modification History
├── 1.17 Postmarketing studies
│ ├── 1.17.1 Correspondence regarding postmarketing commitments
│ └── 1.17.2 Correspondence regarding postmarketing requirements
├── 1.18 Proprietary names
├── 1.19 Pre-EUA and EUA
└── 1.20 General investigational plan for initial IND
Module 2
To view CTOC of Module 2:
print('\n'.join(ctoc.show_ctoc_tree(2)))
2 Module 2 Summaries
├── 2.2 Introduction to summary
├── 2.3 Quality overall summary
├── 2.4 Nonclinical overview
├── 2.5 Clinical overview
├── 2.6 Nonclinical written and tabulated summaries
│ ├── 2.6.1 Introduction
│ ├── 2.6.2 Pharmacology written summary
│ ├── 2.6.3 Pharmacology tabulated summary
│ ├── 2.6.4 Pharmacokinetic written summary
│ ├── 2.6.5 Pharmacokinetic tabulated summary
│ ├── 2.6.6 Toxicology written summary
│ └── 2.6.7 Toxicology tabulated summary
└── 2.7 Clinical summary
├── 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
├── 2.7.2 Summary of Clinical Pharmacology studies
├── 2.7.3 Summary of Clinical Efficacy [indication]
├── 2.7.4 Summary of Clinical Safety
├── 2.7.5 References
└── 2.7.6 Synopses of individual studies
Module 3
To view CTOC of Module 3:
print('\n'.join(ctoc.show_ctoc_tree(3)))
3 Module 3 Quality
├── 3.2 Body of data
│ ├── 3.2.A Appendices
│ │ ├── 3.2.A.1 Facilities and Equipment [name, manufacturer]
│ │ ├── 3.2.A.2 Adventitious agents safety evaluation [name, dosage form, manufacturer]
│ │ └── 3.2.A.3 Novel excipients
│ ├── 3.2.P Drug product [name, dosage form, manufacturer]
│ │ ├── 3.2.P.1 Description and composition of the drug product
│ │ ├── 3.2.P.2 Pharmaceutical development
│ │ ├── 3.2.P.3 Manufacture
│ │ │ ├── 3.2.P.3.1 Manufacturer(s)
│ │ │ ├── 3.2.P.3.2 Batch Formula
│ │ │ ├── 3.2.P.3.3 Description of Manufacturing Process and Process Controls
│ │ │ ├── 3.2.P.3.4 Controls of Critical Steps and Intermediates
│ │ │ └── 3.2.P.3.5 Process Validation and/or Evaluation
│ │ ├── 3.2.P.4 Control of excipients [name]
│ │ │ ├── 3.2.P.4.1 Specification(s)
│ │ │ ├── 3.2.P.4.2 Analytical Procedures
│ │ │ ├── 3.2.P.4.3 Validation of Analytical Procedures
│ │ │ ├── 3.2.P.4.4 Justification of Specifications
│ │ │ ├── 3.2.P.4.5 Excipients of Human or Animal Origin
│ │ │ └── 3.2.P.4.6 Novel Excipients
│ │ ├── 3.2.P.5 Control of drug product
│ │ │ ├── 3.2.P.5.1 Specification(s)
│ │ │ ├── 3.2.P.5.2 Analytical Procedures
│ │ │ ├── 3.2.P.5.3 Validation of Analytical Procedures
│ │ │ ├── 3.2.P.5.4 Batch Analyses
│ │ │ ├── 3.2.P.5.5 Characterization of Impurities
│ │ │ └── 3.2.P.5.6 Justification of Specification(s)
│ │ ├── 3.2.P.6 Reference standards or materials
│ │ ├── 3.2.P.7 Container closure system
│ │ └── 3.2.P.8 Stability
│ │ ├── 3.2.P.8.1 Stability Summary and Conclusion
│ │ ├── 3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment
│ │ └── 3.2.P.8.3 Stability Data
│ ├── 3.2.R Regional information
│ └── 3.2.S Drug substance [name, manufacturer]
│ ├── 3.2.S.1 General information
│ │ ├── 3.2.S.1.1 Nomenclature
│ │ ├── 3.2.S.1.2 Structure
│ │ └── 3.2.S.1.3 General properties
│ ├── 3.2.S.2 Manufacture
│ │ ├── 3.2.S.2.1 Manufacturer(s)
│ │ ├── 3.2.S.2.2 Description of Manufacturing Process and Process Controls
│ │ ├── 3.2.S.2.3 Control of Materials
│ │ ├── 3.2.S.2.4 Controls of Critical Steps and Intermediates
│ │ ├── 3.2.S.2.5 Process Validation and/or Evaluation
│ │ └── 3.2.S.2.6 Manufacturing Process Development
│ ├── 3.2.S.3 Characterization
│ │ ├── 3.2.S.3.1 Elucidation of Structure and other Characteristics
│ │ └── 3.2.S.3.2 Impurities
│ ├── 3.2.S.4 Control of drug substance
│ │ ├── 3.2.S.4.1 Specification
│ │ ├── 3.2.S.4.2 Analytical Procedures
│ │ ├── 3.2.S.4.3 Validation of Analytical Procedures
│ │ ├── 3.2.S.4.4 Batch Analyses
│ │ └── 3.2.S.4.5 Justification of Specification
│ ├── 3.2.S.5 Reference standards or materials
│ ├── 3.2.S.6 Container closure systems
│ └── 3.2.S.7 Stability
│ ├── 3.2.S.7.1 Stability Summary and Conclusions
│ ├── 3.2.S.7.2 Post Approval Stability Protocol and Stability Commitment
│ └── 3.2.S.7.3 Stability Data
└── 3.3 Literature references
Module 4
To view CTOC of Module 4:
print('\n'.join(ctoc.show_ctoc_tree(4)))
4 Module 4 Nonclinical Study Reports
├── 4.2 Study reports
│ ├── 4.2.1 Pharmacology
│ │ ├── 4.2.1.1 Primary pharmacodynamics
│ │ │ └── Study report [identification] and related information
│ │ │ ├── Legacy clinical study report
│ │ │ ├── Pre clinical study report
│ │ │ ├── Synopsis
│ │ │ ├── Study report body
│ │ │ ├── Protocol or amendment
│ │ │ ├── Signatures investigators
│ │ │ ├── Audit certificates report
│ │ │ ├── Statistical methods interim analysis plan
│ │ │ ├── Inter-laboratory standardisation methods quality assurance
│ │ │ ├── Publications based on study
│ │ │ ├── Publications referenced in report
│ │ │ ├── Compliance and drug concentration data
│ │ │ ├── Data tabulation
│ │ │ │ ├── Data tabulation dataset legacy
│ │ │ │ ├── Data tabulation dataset send
│ │ │ │ └── Data tabulation data definition
│ │ │ ├── Data listing dataset
│ │ │ │ ├── Data listing dataset
│ │ │ │ └── Data listing data definition
│ │ │ ├── Analysis datasets
│ │ │ │ ├── Analysis dataset adam
│ │ │ │ ├── Analysis dataset legacy
│ │ │ │ ├── Analysis program
│ │ │ │ └── Analysis data definition
│ │ │ ├── Safety report
│ │ │ ├── Assay validation
│ │ │ ├── Biomarkers
│ │ │ ├── Data monitoring review committees
│ │ │ ├── Device information
│ │ │ ├── Diagnostic tests
│ │ │ ├── Gene therapy
│ │ │ ├── Pharmacodynamics
│ │ │ ├── Pharmacogenomics
│ │ │ ├── Pharmacokinetics
│ │ │ ├── Stem cells
│ │ │ ├── Antibody
│ │ │ ├── Other data not specified
│ │ │ ├── PK PD relationship
│ │ │ ├── Specialty report
│ │ │ └── Foreign clinical studies not under ind
│ │ ├── 4.2.1.2 Secondary pharmacodynamics
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ ├── 4.2.1.3 Safety pharmacology
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ └── 4.2.1.4 Pharmacodynamic drug interactions
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.2 Pharmacokinetics
│ │ ├── 4.2.2.1 Analytical methods and validation reports
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ ├── 4.2.2.2 Absorption
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ ├── 4.2.2.3 Distribution
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ ├── 4.2.2.4 Metabolism
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ ├── 4.2.2.5 Excretion
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ ├── 4.2.2.6 Pharmacokinetic drug interactions
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ └── 4.2.2.7 Other pharmacokinetic studies
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ └── 4.2.3 Toxicology
│ ├── 4.2.3.1 Single dose toxicity [Species and route]
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.2 Repeat dose toxicity [Species, route, duration]
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.3 Genotoxicity
│ │ ├── 4.2.3.3.1 In vitro
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ └── 4.2.3.3.2 In vivo
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.4 Carcinogenicity
│ │ ├── 4.2.3.4.1 Long term studies [Species]
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ ├── 4.2.3.4.2 Short or medium term studies
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ └── 4.2.3.4.3 Other studies
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.5 Reproductive and developmental toxicity
│ │ ├── 4.2.3.5.1 Fertility and early embryonic development
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ ├── 4.2.3.5.2 Embryofetal development
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ ├── 4.2.3.5.3 Prenatal and postnatal development, including maternal function
│ │ │ └── Study report [identification number] and related information
│ │ │ └── See 4.2.1.1
│ │ └── 4.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.6 Local tolerance
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ └── 4.2.3.7 Other toxicity studies
│ ├── 4.2.3.7.1 Antigenicity
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.7.2 Immunotoxicity
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.7.3 Mechanistic studies
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.7.4 Dependence
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.7.5 Metabolites
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ ├── 4.2.3.7.6 Impurities
│ │ └── Study report [identification number] and related information
│ │ └── See 4.2.1.1
│ └── 4.2.3.7.7 Other
│ └── Study report [identification number] and related information
│ └── See 4.2.1.1
└── 4.3 Literature references
Module 5
To view CTOC of Module 5:
print('\n'.join(ctoc.show_ctoc_tree(5)))
5 Module 5 Clinical Study Reports
├── 5.2 Tabular listing of all clinical studies
├── 5.3 Clinical study reports and related information
│ ├── 5.3.1 Reports of biopharmaceutic studies
│ │ ├── 5.3.1.1 Bioavailability (BA) Study reports and related information
│ │ │ └── Study report [identification] and related information
│ │ │ ├── Legacy clinical study report
│ │ │ ├── Synopsis (ICH E3, section 2)
│ │ │ ├── Study report body (E3 1, 3 to 15)
│ │ │ ├── Protocol or amendment (E3 16.1.1)
│ │ │ ├── Sample case report form (E3 16.1.2)
│ │ │ ├── IEC-IRB consent form list (E3 16.1.3)
│ │ │ ├── List description investigator site (E3 16.1.4)
│ │ │ ├── Signatures investigators (E3 16.1.5)
│ │ │ ├── List patients with batches (E316.1.6)
│ │ │ ├── Randomisation scheme (E3 16.1.7)
│ │ │ ├── Audit certificates report (E3 16.1.8)
│ │ │ ├── Statistical methods interim analysis plan (E3 16.1.9)
│ │ │ ├── Inter-laboratory standardisation methods quality assurance (E3 16.1.10)
│ │ │ ├── Publications based on study (E3 16.1.11)
│ │ │ ├── Publications referenced in report (E3 16.1.12)
│ │ │ ├── Discontinued patients (E3 16.2.1)
│ │ │ ├── Protocol deviations (E3 16.2.2)
│ │ │ ├── Patients excluded from efficacy analysis (E3 16.2.3)
│ │ │ ├── Demographic data (E3 16.2.4)
│ │ │ ├── Compliance and drug concentration data (E3 16.2.5)
│ │ │ ├── Individual efficacy response data (E3 16.2.6)
│ │ │ ├── Adverse event listings (E3 16.2.7)
│ │ │ ├── Listing individual laboratory measurements by patient (E3 16.2.8)
│ │ │ ├── Case report forms (E3 16.3)
│ │ │ │ └── Site [identifier]
│ │ │ ├── Available on request
│ │ │ ├── Data tabulation
│ │ │ │ ├── Data tabulation dataset legacy
│ │ │ │ ├── Data tabulation dataset sdtm
│ │ │ │ └── Data tabulation data definition
│ │ │ ├── Data listing dataset (E3 16.4)
│ │ │ │ ├── Data listing dataset
│ │ │ │ └── Data listing data definition
│ │ │ ├── Analysis datasets
│ │ │ │ ├── Analysis dataset adam
│ │ │ │ ├── Analysis dataset legacy
│ │ │ │ ├── Analysis program
│ │ │ │ └── Analysis data definition
│ │ │ ├── Annotated CRF
│ │ │ ├── ECG
│ │ │ ├── Image
│ │ │ ├── Subject profiles
│ │ │ ├── Safety report
│ │ │ ├── Assay validation
│ │ │ ├── Biomarkers
│ │ │ ├── Data monitoring review committees
│ │ │ ├── Device information
│ │ │ ├── Diagnostic tests
│ │ │ ├── Gene therapy
│ │ │ ├── Patient reported outcomes
│ │ │ ├── Pharmacodynamics
│ │ │ ├── Pharmacogenomics
│ │ │ ├── Pharmacokinetics
│ │ │ ├── Quality of life
│ │ │ ├── Stem cells
│ │ │ ├── Abuse liability
│ │ │ ├── Antibody
│ │ │ ├── Healthcare utilization
│ │ │ ├── Other data not specified
│ │ │ ├── PK PD relationship
│ │ │ ├── Specialty report
│ │ │ └── Foreign clinical studies not under ind
│ │ ├── 5.3.1.2 Comparative BA and bioequivalence (BE) Study reports and related information
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ ├── 5.3.1.3 In Vitro - in Vivo correlation Study reports and related information
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ └── 5.3.1.4 Reports of bioanalytical and analytical methods for human studies
│ │ └── Study report [identification] and related information
│ │ └── See 5.3.1.1
│ ├── 5.3.2 Reports of studies pertinent to pharmacokinetics using human biomaterials
│ │ ├── 5.3.2.1 Plasma protein binding Study reports and related information
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ ├── 5.3.2.2 Reports of hepatic metabolism and drug interaction studies
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ └── 5.3.2.3 Reports of studies using other human biomaterials
│ │ └── Study report [identification] and related information
│ │ └── See 5.3.1.1
│ ├── 5.3.3 Reports of human pharmacokinetic (PK) studies
│ │ ├── 5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ ├── 5.3.3.2 Patient PK and initial tolerability Study reports and related information
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ ├── 5.3.3.3 Intrinsic factor PK Study reports and related information
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ ├── 5.3.3.4 Extrinsic factor Study reports and related information
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ └── 5.3.3.5 Population PK Study reports and related information
│ │ └── Study report [identification] and related information
│ │ └── See 5.3.1.1
│ ├── 5.3.4 Reports of human pharmacodynamic (PD) studies
│ │ ├── 5.3.4.1 Healthy subject PD and PK/PD Study reports and related information
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ └── 5.3.4.2 Patient PD and PK/PD Study reports and related information
│ │ └── Study report [identification] and related information
│ │ └── See 5.3.1.1
│ ├── 5.3.5 Reports of efficacy and safety studies [Indication]
│ │ ├── 5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication [type of control]
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ ├── 5.3.5.2 Study reports and related information of uncontrolled clinical studies
│ │ │ └── Study report [identification] and related information
│ │ │ └── See 5.3.1.1
│ │ ├── 5.3.5.3 Reports of analyses of data from more than one study
│ │ │ └── Study report [identification] and related information
│ │ │ ├── Integrated analysis of safety
│ │ │ │ ├── Iss
│ │ │ │ └── Analysis datasets
│ │ │ │ ├── Analysis dataset adam
│ │ │ │ ├── Analysis dataset legacy
│ │ │ │ ├── Analysis program
│ │ │ │ └── Analysis data definition
│ │ │ └── Integrated analysis of efficacy
│ │ │ ├── Ise
│ │ │ └── Analysis datasets
│ │ │ ├── Analysis dataset adam
│ │ │ ├── Analysis dataset legacy
│ │ │ ├── Analysis program
│ │ │ └── Analysis data definition
│ │ └── Other Study reports and related information [see 5.3.5.4.pseudo]
│ │ └── Study report [identification] and related information
│ │ ├── Antibacterial microbiology reports
│ │ │ └── Antibacterial
│ │ ├── Special pathogens (e.g., fungi, parasites, mycobacteria) and immune
│ │ ├── modulator reports
│ │ │ └── Special pathogen
│ │ ├── Antiviral reports
│ │ │ └── Antiviral
│ │ ├── BIMO
│ │ │ └── bimo
│ │ └── Human Factor
│ │ ├── HF-validation-protocol
│ │ ├── HF-validation-report
│ │ └── HF-validation-other
│ └── 5.3.6 Reports of postmarketing experience
│ └── (This line is added line by the software for displaying purpose)
│ ├── Postmarketing periodic adverse event drug experience report
│ └── description
└── 5.4 Literature references
Find Sections Using Keywords
Please note that keywords are not case sensitive, but titles are case sensitive.
To search for a word within the hierarchy:
print('\n'.join(ctoc.find_section_given_words('REMS')))
1.16.1 Risk Management (Non-REMS)
1.16.2 Risk Evaluation and Mitigation Strategy (REMS)
1.16.2.1 Final REMS
1.16.2.2 Draft REMS
1.16.2.3 REMS Assessment
1.16.2.4 REMS Assessment Methodology
1.16.2.5 REMS Correspondence
1.16.2.6 REMS Modification History
To include the upper CTOC sections that include search results:
print("\n".join(ctoc.find_section_given_words("REMS", outfmt='tree')))
1 Module 1 Administrative information
└── 1.16 Risk management plan
├── 1.16.1 Risk Management (Non-REMS)
└── 1.16.2 Risk Evaluation and Mitigation Strategy (REMS)
├── 1.16.2.1 Final REMS
├── 1.16.2.2 Draft REMS
├── 1.16.2.3 REMS Assessment
├── 1.16.2.4 REMS Assessment Methodology
├── 1.16.2.5 REMS Correspondence
└── 1.16.2.6 REMS Modification History
To search for multiple keywords:
print("\n".join(ctoc.find_section_given_words(words=["REMS","dsur"], outfmt='tree', colored=['magenta','blue','red','whatever'])))
1 Module 1 Administrative information
├── 1.13 Annual report
│ └── 1.13.15 Development safety update report (DSUR)
└── 1.16 Risk management plan
├── 1.16.1 Risk Management (Non-REMS)
└── 1.16.2 Risk Evaluation and Mitigation Strategy (REMS)
├── 1.16.2.1 Final REMS
├── 1.16.2.2 Draft REMS
├── 1.16.2.3 REMS Assessment
├── 1.16.2.4 REMS Assessment Methodology
├── 1.16.2.5 REMS Correspondence
└── 1.16.2.6 REMS Modification History
To use another color:
print("\n".join(ctoc.find_section_given_words(words="dsur", outfmt='tree', colored='green')))
1 Module 1 Administrative information
└── 1.13 Annual report
└── 1.13.15 Development safety update report (DSUR)