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Table 2 Global benchmarking tool sub-indicators for clinical trials oversight relevant to public health emergency preparedness

From: Leveraging WHO’s Global Benchmarking Tool to strengthen capacity in clinical trials oversight for public health emergencies: the GHPP VaccTrain model

No.

(Sub-)Indicator

ML

 

CT01 Legal provisions, regulations and guidelines required to define regulatory framework of clinical trials oversight.

 

CT01.01

Legal provisions and regulations for clinical trials (CTs) oversight exist.

1

CT01.05

There are legal provisions or regulations covering circumstances in which the routine CT evaluation procedures may not be followed (e.g. for public-health interests)

2

CT01.11

Legal provisions / regulations allow NRAs to recognize and use relevant CT decisions, reports or information from other NRAs or from regional and international bodies.

1

 

CT04 Procedures established and implemented to perform clinical trials oversight.

 

CT04.07

The same policies are used for the evaluation of CT applications regardless of the applicant (e.g., domestic, foreign, public sector, or private sector)

3

 

CT06 Mechanism in place to monitor regulatory performance and output.

 

CT06.04

There are timelines for the assessment of CT applications and an internal tracking system to follow the targeted time frames

3