Table of Contents Mapping INSERT COMPANY NAME TOC to Transcelerate CPT TOC

Table of Contents – mapping [INSERT COMPANY NAME] TOC to TransCelerate CPT TOC

Versions Compared: [INSERT COMPANY NAME] [DATE] TransCelerate May 2017.

TransCelerate CPT
Heading / Section IN toc / Comments/GAPS /
TransCeleratE CPT SECTION # / [Company NAME]
SECTION # /
Title Page / NONE
Signature Page / NONE
Protocol Amendment Summary of Changes Table / NONE
Table of Contents / none
Protocol Summary / 1.
Synopsis / 1.1.
Schema / 1.2.
Schedule of Activities(SoA) / 1.3.
Introduction / 2.
Study Rationale / 2.1.
Background / 2.2.
Benefit/Risk Assessment / 2.3.
Objectives and Endpoints / 3.
Study Design / 4.
Overall Design / 4.1.
Scientific Rationale for Study Design / 4.2.
Justification for Dose / 4.3.
End of Study Definition / 4.4.
Study Population / 5.
Inclusion Criteria / 5.1.
Exclusion Criteria / 5.2.
Lifestyle Considerations / 5.3.
Meals and Dietary Restrictions / 5.3.1.
Caffeine, Alcohol, and Tobacco / 5.3.2.
Screen Failures / 5.4.
Study Intervention / 6.
Study Intervention(s) Administered / 6.1.
Medical Devices / 6.1.1.
Preparation/Handling/Storage/
Accountablility / 6.2.
Measures to Minimize Bias: Randomization and Blinding / 6.3.
Study Intervention Compliance / 6.4.
Concomitant Therapy / 6.5.
Rescue Medicine / 6.5.1.
Dose Modification / 6.6.
Intervention after the End of the Study / 6.7.
Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal / 7.
Discontinuation of Study Intervention / 7.1.
Temporary Discontinuation / 7.1.1.
Rechallenge / 7.1.2.
Participant Discontinuation/Withdrawal from the Study / 7.2.
Lost to Follow Up / 7.3.
Study Assessments and Procedures / 8.
Efficacy Assessments / 8.1.
Safety Assessments / 8.2.
Physical Examinations / 8.2.1.
Vital Signs / 8.2.2.
Electrocardiograms / 8.2.3.
Clinical Safety Laboratory Assessments / 8.2.4.
Suicidal Risk Monitoring / 8.2.5.
Adverse Events and Serious Adverse Events / 8.3.
Time Period and Frequency for Collecting AE and SAE Information / 8.3.1.
Method of Detecting AEs and SAEs / 8.3.2.
Follow-up of AEs and SAEs / 8.3.3.
Regulatory Reporting Requirements for SAEs / 8.3.4.
Pregnancy / 8.3.5.
Cardiovascular and Death Events / 8.3.6.
Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs or SAEs / 8.3.7.
Medical Device Incidents (Including Malfunctions) / 8.3.8.
Treatment of Overdose / 8.4.
Pharmacokinetics / 8.5.
Pharmacodynamics / 8.6.
[Genetics] / 8.7.
Biomarkers / 8.8.
Immunogenicity Assessments [if applicable] / 8.8.1.
RNA Transcriptome Research [if applicable] / 8.8.2.
RNA Expression Research of a Subset of RNA Species[if applicable] / 8.8.3.
Proteome Research [if applicable] / 8.8.4.
Metabolomic Research [if applicable] / 8.8.5.
[Health Economics] OR [Medical Resource Utilization and Health Economics] / 8.9.
Statistical Considerations / 9.
Statistical Hypotheses / 9.1.
Sample Size Determination / 9.2.
Populations for Analyses / 9.3.
Statistical Analyses / 9.4.
Efficacy Analyses / 9.4.1.
Safety Analyses / 9.4.2.
Other Analyses / 9.4.3.
Interim Analyses / 9.5.
Data Monitoring Committee (DMC) / 9.5.1.
Supporting Documentation and Operational Considerations / 10.
Appendix 1: Regulatory, Ethical, and Study Oversight Considerations / 10.1.
Regulatory and Ethical Considerations / 10.1.1.
Financial Disclosure / 10.1.2.
Informed Consent Process / 10.1.3.
Data Protection / 10.1.4.
Committee Structure / 10.1.5.
Dissemination of Clinical Study Data / 10.1.6.
Data Quality Assurance / 10.1.7.
Source Documents / 10.1.8.
Study and Site Closure / 10.1.9.
Publication Policy / 10.1.10.
Appendix 2: Clinical Laboratory Tests / 10.2.
Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow up, and Reporting / 10.3.
Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information / 10.4.
Appendix 5: Genetics / 10.5.
Appendix 6: Liver Safety: Suggested Actions and Follow up Assessments [and Study Intervention Rechallenge Guidelines] / 10.6.
Appendix 7: Medical Device Incidents: Definition and Procedures for Recording, Evaluating, Follow up, and Reporting / 10.7.
Appendix 8:Country-specific Requirements / 10.8.
Appendix 9: Abbreviations / 10.9.
Appendix 10: Protocol Amendment History / 10.10.
References / 11.