Download Terms of Reference - Sir Charles Gairdner Hospital

Sir Charles Gairdner Hospital
TERMS OF REFERENCE
CLINICAL DRUG TRIALS COMMITTEE
INDEX
1. ORIGIN ........................................................................................................................ 2
2. PURPOSE .................................................................................................................... 2
3. ACCOUNTABILITY ...................................................................................................... 2
4. RESPONSIBILITIES .................................................................................................... 2
5. MEMBERSHIP AND OPERATING PROCEDURES .................................................... 2
5.1 Membership ............................................................................................................................................. 2
5.2 Terms of Members .................................................................................................................................. 2
5.3 Chairman.................................................................................................................................................. 2
5.4 Acting Chairman ..................................................................................................................................... 2
5.5 Authority of the Chairman ...................................................................................................................... 2
5.6 Meetings .................................................................................................................................................. 3
5.7 Recommendations .................................................................................................................................. 3
5.8 Powers of Committee ............................................................................................................................. 3
5.9 Appeal Mechanism.................................................................................................................................. 3
5.10 Record of Proceedings ......................................................................................................................... 3
5.11 Substitution ........................................................................................................................................... 3
5.12 Voting Rights ......................................................................................................................................... 3
5.13 Quorum .................................................................................................................................................. 3
5.14 Special Meetings ................................................................................................................................... 3
5.15 Conduct of Meetings ............................................................................................................................ 3
5.16 Circulation of Agenda and Minutes ..................................................................................................... 3
5.17 Confirmation of Minutes....................................................................................................................... 3
5.18 Amendments to the Terms of Reference ............................................................................................ 4
6. DEFINITION OF INVESTIGATIONAL DRUGS ............................................................ 4
7. DEFINITION OF A CLINICAL TRIAL........................................................................... 4
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TERMS OF REFERENCE
CLINICAL DRUG TRIALS COMMITTEE
1. ORIGIN
The Clinical Drug Trials Committee was formed by the Medical Advisory Committee in January
1986.
2. PURPOSE
The purpose of the Clinical Drug Trials Committee is to act as the Hospital’s scientific advisory
committee with respect to clinical trials of “investigational” drugs, as defined in Sections 6 & 7 of
these Terms of Reference.
3. ACCOUNTABILITY
The Clinical Drug Trials Committee is accountable to the Human Research Ethics Committee.
4. RESPONSIBILITIES
The Clinical Drug Trials Committee is responsible to:
a. Ensure that the trials of “investigational” drugs performed Sir Charles Gairdner Hospital have
a valid scientific basis and design;
b. Assist members of Sir Charles Gairdner Hospital staff in preparation of drug trial protocols, if
desired.
5. MEMBERSHIP AND OPERATING PROCEDURES
5.1 Membership
The Clinical Drug Trials Committee will comprise:
a.
b.
c.
d.
TWO (2) Clinicians nominated by the Medical Services Committee;
Head of the Department of Clinical Pharmacology or nominee;
The Chief Pharmacist;
A Biostatistician.
5.2 Terms of Members
Members should be re-nominated every three (3) years, but may serve more than one
consecutive term.
5.3 Chairman
The Chairman is appointed by the Human Research Ethics Committee from amongst the
Clinical Drug Trials Committee’s members.
5.4 Acting Chairman
In the absence of the Chairman, members will elect an Acting Chairman by simple majority vote.
5.5 Authority of the Chairman
The Chairman is authorised to explain any resolution, arrived at by the Committee, and to give
advice and direction to the Human Research Ethics Committee between meetings.
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5.6 Meetings
Meetings will be arranged as necessary by the Chairman to consider protocols of drug trials
proposed to be conducted at Sir Charles Gairdner Hospital.
Meetings will normally be held each month
5.7 Recommendations
Following evaluation of the scientific aspects of protocols, recommendations will be made to the
Human Research Ethics Committee for acceptance of trial protocols.
5.8 Powers of Committee
The Committee may seek further information and clarification from investigators during or
between meetings. The Committee may also co-opt persons who it is considered may aid the
work of the Committee.
5.9 Appeal Mechanism
Researchers whose protocols have been rejected by the Committee have a right to put their
case in person to the Committee. Researchers also have a right to appeal directly to the Human
Research Ethics Committee.
5.10 Record of Proceedings
Formal minutes are taken at all Committee meetings. They will be recorded by the Executive
Officer to the Committee. A copy of the minutes will be submitted to the Human Research
Ethics Committee.
5.11 Substitution
A Committee member may arrange for a deputy to attend a meeting, subject to agreement of
the Chairman.
5.12 Voting Rights
Each member of the Committee has the right to vote. A proxy or a substitute member also has
the right to vote. A co-opted person or any other individual in attendance (e.g. the person
recording the minutes) may not vote.
5.13 Quorum
Half of the members will constitute a quorum.
5.14 Special Meetings
The Chairman must convene a special meeting within seven (7) days of receipt by him of a
written request signed by at least two (2) members. All members must receive at least 24 hours
notice, in writing, prior to a special meeting.
5.15 Conduct of Meetings
The decision of the Chairman is final in all matters of procedure and order.
5.16 Circulation of Agenda and Minutes
Following approval by the Chairman, minutes are circulated to all members. An agenda should
be circulated to all members seven days prior to the next scheduled meeting.
5.17 Confirmation of Minutes
Minutes are ratified by the Chairman’s signature at Committee meetings. Minutes are retained
by the Executive Officer on file in a secure location.
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5.18 Amendments to the Terms of Reference
Amendments to the Terms of Reference may only be made through the Human Research
Ethics Committee.
6. DEFINITION OF INVESTIGATIONAL DRUGS
A drug will be defined as any therapeutic or diagnostic agent (including radiopharmaceuticals,
contrast media, and other agents used for in vivo diagnostic testing) and including agents for
which marketing approval (under the Therapeutic Goods Act) exists, agents for which clinical
trial exemption exists under either the Clinical Trial Exemption System (CTX) or the Clinical
Trials Notification System (CTN) schemes and agents which are not controlled by the
Therapeutic Goods Act (e.g. natural products and agents not transported across State or
National boundaries). The term “investigational drug” will apply to any drug whose effects;
safety, utility, pharmacokinetics or interactions (with other drugs, foods, etc.) are being studied in
human subjects.
7. DEFINITION OF A CLINICAL TRIAL
A clinical trial is an investigation of a group of patients or subjects for the purpose of addressing
scientific questions and does not cover clinical decisions made in the direct management of
individual patients.
First Revision:
Second Revision:
Third Revision:
Last Printed:
September 1991
February 1999
April 2008
May 2, 2017
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