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 ©Copyright
 Published: 14/03/2008

DELEGATED AUTHORITY REGISTER - clinical research

Topic

 

 

Protocols are reviewed regularly & updated as required.  Printed copies of this document may not be valid.  The electronic version is the only controlled version in current use within ADHB.

 

 

Overview

Functional Responsibility

Deputy Chief Medical Officer

 

General Manager’s Responsibility

Responsibility rests with the General Manager concerned to ensure that all required approvals are obtained.

 

All research projects must comply with requirements of law e.g. Privacy Act. It is the General Manager’s responsibility to ensure all relevant acts are adhered to.

 

No funds may be expended until all required approvals have been obtained and under no circumstances can any research proceed before ethical approval is granted.

 

Approvals External to ADHB

There a number of approvals which must be obtained prior to the commencement of any research within ADHB.

 

The approval process is detailed in ADHB Policy: Research - Application and Approval Process.

 

Specific Requirements

Some research projects require approval from specific bodies e.g. National Radiation Laboratory approval for radiation used in research and Standing Committee on Therapeutic Trials (S.C.O.T.T.) approval for unregistered medicines or formulations to be used in a trial. Responsibility rests with the General Manager concerned to ensure these aspects have been covered.

 

Reporting Requirements

Procedures will be developed for regularly reporting to the G.M. concerned the status of projects currently underway e.g. continuing/completed etc.

 

 

Summary 9: Clinical Research

No.

Description

Level 1

Level 2

Level 3

Level 4

Other Comments

 

Research Projects

 

 

 

 

 

9.1

Approve and sign indemnity and compensation statements for research

FA

FA

Research Manager

 

Statements must follow ADHB approved standard format/checked by ADHB Legal Dept

9.2*

Approve a financial contract for research

FA

FA

Research

Manager

<$50,000

 

Approval only if contract meets standard ADHB contract requirements

9.3*

Approve a financial contract for research – not covered under 8.2

FA

FA

 

 

Contract must be endorsed by Corporate Counsel

9.4

Approval of resource use and management budget

FA

FA

 

 

Anticipated will be delegated to RC Manager

9.5

Final approval of research

 

 

 

 

Authority vested in research Review Committee