Mapping protocol level risks to visual indicators and thresholds at the RBM planning stage, some practical

examples

Nick Hargaden22nd October 2014

eCF US Conference 2014, Boston

Problem

RACT FRAMEWORK

MONITORING PLAN

Problem

RACT IQRMP RISK INDICATORS

• WEAK LINKS / LOOSELY CONTROLLED

• NO EFFECTIVE CHANGE MANAGEMENT

Solution

Practical Examples

RACT IQRMP RISK INDICATORS

• Example 1: Subject Safety

• Example 2: Data Integrity

• Example 3: Regulatory Compliance

Subject Safety

Subject Safety

Subject Safety

Subject Safety

Subject Safety

Subject Safety

Data Integrity

Data Integrity

Data Integrity

Data Integrity

Data Integrity

Data Integrity

Regulatory Compliance

Regulatory Compliance

Regulatory Compliance

Regulatory Compliance

Regulatory Compliance

Summary

Summary

RACT IQRMP RISK INDICATORS

• Process links can be effectively controlled by technology

• Any amendments in the protocol are tightly controlled with RACT and its associated plans and its associated alert or indicators