CCRC Exam Prep 2025
When was the declaration of Helsinki created - answer1964
What are the 4 highlights of the Declaration of Helsinki - answer1) The importance of
informed consent
2) The requirement of ethical review and approval of research before it is undertaken
3) The acknowledgement and guidance of special protections for vulnerable subjects
4) The recommendation that clinical trials are registered on public databases
What is ICH E2A? - answer Clinical Safety Data management: Definitions and standard
for expedited reporting
What 3 concepts are in ICH E2A? - answer1) Definitions of Adverse reactions, Adverse
drug reactions and serious adverse events
2) The concept of expectedness of adverse events and the role of the IB in determining
the expectedness of an event
3) The reporting timelines for sponsors to notify regulatory authorities of serious adverse
drug reactions
What is ICH E6 (R2)? - answer guidelines of GCP (Also referred to ICH GCP)
What 2 main concepts of ICH E6 (R2) - answer1) Responsibilities of key parties
involved in clinical trials, including IRB/IEC, investigator, sponsor and monitor
2) Standardized contents of a protocol and IB and details requirements for essential
documents required before, during and after a trial
What is ICH E8 - answerprovides guidance on general scientific principle for clinical
trials including trial objectives, design, conduct, analysis and reporting
When is the ICH E8 useful - answerwhen creating the product development plan and
understanding the product development cycle from non-clinical to clinical studies and
various phases of clinical development
What is ICH E9 and what does it provide? (2) - answerguideline for statistical principles
for clinical trials.
Provides info on:
1)techniques to reduce bias such as blinding and randomization
2) definitions for various treatment sequence and study design, control and subject
assignment methods
What is ICH E11 - answerguideline on clinical trials in pediatric populations
When was the declaration of Helsinki created - answer1964
What are the 4 highlights of the Declaration of Helsinki - answer1) The importance of
informed consent
2) The requirement of ethical review and approval of research before it is undertaken
3) The acknowledgement and guidance of special protections for vulnerable subjects
4) The recommendation that clinical trials are registered on public databases
What is ICH E2A? - answer Clinical Safety Data management: Definitions and standard
for expedited reporting
What 3 concepts are in ICH E2A? - answer1) Definitions of Adverse reactions, Adverse
drug reactions and serious adverse events
2) The concept of expectedness of adverse events and the role of the IB in determining
the expectedness of an event
3) The reporting timelines for sponsors to notify regulatory authorities of serious adverse
drug reactions
What is ICH E6 (R2)? - answer guidelines of GCP (Also referred to ICH GCP)
What 2 main concepts of ICH E6 (R2) - answer1) Responsibilities of key parties
involved in clinical trials, including IRB/IEC, investigator, sponsor and monitor
2) Standardized contents of a protocol and IB and details requirements for essential
documents required before, during and after a trial
What is ICH E8 - answerprovides guidance on general scientific principle for clinical
trials including trial objectives, design, conduct, analysis and reporting
When is the ICH E8 useful - answerwhen creating the product development plan and
understanding the product development cycle from non-clinical to clinical studies and
various phases of clinical development
What is ICH E9 and what does it provide? (2) - answerguideline for statistical principles
for clinical trials.
Provides info on:
1)techniques to reduce bias such as blinding and randomization
2) definitions for various treatment sequence and study design, control and subject
assignment methods
What is ICH E11 - answerguideline on clinical trials in pediatric populations
