Table of Contents – mapping [INSERT COMPANY NAME] TOC to TransCelerate TOC
Versions Compared: [INSERT COMPANY NAME] [DATE] TransCelerate v1.
TRANSCELERATE HEADING
SECTION/LINK IN TOC
TRANSCELERATE
Table of Contents
NONE
Synopsis
1.
Schedule of Activities
2.
Introduction
3.
Study Rationale
3.1.
Background
3.2.
Benefit/Risk Assessment
3.3.
Objectives and Endpoints
4.
Study Design
5.
Overall Design
5.1.
Number of Participants
5.2.
End of Study Definition
5.3.
Scientific Rationale for Study Design
5.4.
COMMENTS/GAPS
[COMPANY
NAME]
© 2015 TransCelerate BioPharma
Justification for Dose
5.5.
Study Population
6.
Inclusion Criteria
6.1.
Exclusion Criteria
6.2.
Lifestyle Restrictions
6.3.
Meals and Dietary Restrictions
6.3.1.
Caffeine, Alcohol, and Tobacco
6.3.2.
Activity
6.3.3.
Screen Failures
6.4.
Treatment
7.
Treatment Administered
7.1.
Medical Devices
7.1.1.
Method of Treatment Assignment
7.2.
Blinding
7.3.
Dosage Modification
7.4.
Preparation/Handling/Storage/Accountablili
ty
7.5.
Treatment Compliance
7.6.
Concomitant Therapy
7.7.
© 2015 TransCelerate BioPharma
Treatment After the End of the Study
7.8.
Discontinuation Criteria
8.
Discontinuation from Study Treatment
8.1.
Temporary Discontinuation
8.1.1.
Rechallenge
8.1.2.
Discontinuation from the Study
8.2.
Lost to Follow Up
8.3.
Study Assessments and Procedures
9.
Efficacy Assessments
9.1.
Adverse Events
9.2.
Time Period and Frequency for Collecting
AE and SAE Information
9.2.1.
Method of Detecting AEs and SAEs
9.2.2.
Follow-up of AEs and SAEs
9.2.3.
Regulatory Reporting Requirements for
SAEs
9.2.4.
Pregnancy
9.2.5.
Medical Device Incidents (Including
Malfunctions)
9.2.6.
Treatment of Overdose
9.3.
© 2015 TransCelerate BioPharma
Safety
9.4.
Physical Examinations
9.4.1.
Vital Signs
9.4.2.
Electrocardiogram (ECG)
9.4.3.
Clinical Safety Laboratory Assessments
9.4.4.
Suicidal Risk Monitoring
9.4.5.
Pharmacokinetics
9.5.
Pharmacodynamics
9.6.
[Pharmacogenomics] OR [Genetics]
9.7.
Biomarkers [and [specify other analyses] ]
9.8.
Immunogenicity Assessments [if applicable]
9.8.1.
RNA Transcriptome Research [if
applicable]
9.8.2.
RNA Expression Research of a Subset of
RNA Species[if applicable]
9.8.3.
Proteome Research [if applicable]
9.8.4.
Metabolomic Research [if applicable]
9.8.5.
Health Economics OR Medical Resource
Utilization and Health Economics
9.9.
Statistical Considerations
10.
© 2015 TransCelerate BioPharma
Sample Size Determination
10.1.
Populations for Analyses
10.2.
Statistical Analyses
10.3.
Efficacy Analyses
10.3.1.
Safety Analyses
10.3.2.
Other Analyses [if applicable]
10.3.3.
Interim Analyses [if applicable]
10.3.4
References
11.
Appendices
12.
Abbreviations and Trademarks
Appendix 1
Clinical Laboratory Tests
Appendix 2
Study Governance Considerations
Appendix 3
Adverse Events: Definitions and Procedures
for Recording, Evaluating, Follow up and
Reporting
Appendix 4
Collection of Pregnancy Information
Appendix 5
Pharmacogenomics
Appendix 6
Liver Safety Suggested Actions and Follow
up Assessments AND Liver Safety Drug
Restart or Rechallenge Guidelines
Appendix 7
© 2015 TransCelerate BioPharma
Medical Device Incidents: Definition and
Procedures for Recording, Evaluating,
Follow up and Reporting
Appendix 8
Country-specific requirements
Appendix 9
© 2015 TransCelerate BioPharma