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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 Clinical Drug Trials Committee \ terms of reference Page 1 of 4 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. Clinical Drug Trials Committee \ terms of reference Page 2 of 4 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. Clinical Drug Trials Committee \ terms of reference Page 3 of 4 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 Clinical Drug Trials Committee \ terms of reference Page 4 of 4