What and Why

• To translate country regulations and ethics processes and requirements into ready-to-use operational guidelines and templates and upload them onto the CTC platform.

 

Goals

• Identify, map and translate national regulations and ethics processes (and associated requirements) into standardised operational guidelines and templates, available through the CTC platform.

• Capture metrics associated with ethics and regulatory review.

• Promote a centralised online functionality for submission and approvals of clinical trials applications to national regulatory authorities but also as part of the ethics application to IRBs.

 

Activities

• Task 4.1: Identify relevant clinical trial regulatory and ethics requirements.

• Task 4.2: Operationalise country regulations and ethics process and requirements.

• Task 4.3: Promote digital clinical trial application, review, and approval through CTC platform.

 

Expected outcomes

• Regulatory and Ethics Operational Templates and Process Maps.

• Predictable timelines for clinical trial applications, and harmonised and predictable clinical trial regulations will bring more clinical trials to the country.

 

Freedoms

• Existing relationship with relevant stakeholders.

• The formation of AMA and opportunities for synergy.

 

Constraints

• Limited resources.

• Lack of harmonisation across national regulatory agencies.