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Q-Pharm

A CRC’s View on Conduct of Clinical Drug Study in Australia and Japan A Comparison between Ebara Hospital and Q-Pharm

1,2 1 1

Aya Kobayashi1,2, Tsuneyoshi Yamazaki1, Toshio Suwa1

1 2

1Department of Drug Development Science and Clinical Evaluation, Kyoritsu University of Pharmacy 2Clinical Research Center, Tokyo Metropolitan Health and Medical Treatment Ebara Hospital

(Received August 1, 2007; Revised September 20, 2007, Accepted September 27, 2007)

A comparison was made on the conduct of clinical trial at the Tokyo Metropolitan Health and Medical Treatment Ebara Hospital in Japan and Q-Pharm Pty Limited in Australia.

The followings were pointed out as the differences of role and responsibility between CRC of Ebara Hospital and SC of Q-Pharm..

1) The SC of Q-Pharm is actively involved in managing clinical study itself, such as organizing study team members. The attitude of CRCs of Ebara Hospital is inclined to assist investigator rather than manage. The CRCs also make considerable effort in coordinating functions in the hospital and are involved in the study.

2) The coverage of CRC at Ebara Hospital is wider than that of SC of Q-Pharm. The tasks of CRC extend from contacting to sponsor before the contract is signed, complementary explanation of the study to recruited study subjects, participation to study audit. The main tasks of SC start from initiation of a study. The SC does not get involved in obtaining the informed consent from study subjects.

3) The role and responsibility of SC of Q-Pharm is described in the job description, whereas, no job description is available for CRC of Ebara Hospital.

4) It is presumed that the clarification of the job of CRC in Japanese study sites will lead to the improvement of efficiency of clinical study conduct.

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Position Purpose: a. To carry out clinical trial research contributing to better clinical management. b. To aid/assist supervisors to perform correct clinical trial practice and monitoring Major Responsibility Areas: a. To co-ordinate and assist in the execution of trials b. Maintain accurate patient data and ensure completion of CRF c. Collection of specimen specific for clinical trials d. Demonstrate knowledge of aseptic technique and universal precautions when dealing with blood

and body products. e. To aid in the smooth running of the research unit. f. Demonstrate the ability to follow written and verbal guidelines and instructions essential for

experimental drug trials and clinical research projects g. Demonstrate proficiency in collection of patient data and the ability to work with understanding and

co-operation within a team of health care workers h. To actively be involved in research unit meeting i. Responsibility for operation of trial centre on clinical study days j. Maintenance of clinical records k. Maintenance of compliance with study protocol l. Assisting in the management of the clinical trials centre m. Preparation of clinic for trial days n. Taking and recording of clinical observations o. Collection of blood samples by venipuncture p. Assist with the planning and implementation of work instructions for use in the clinical setting. q. Liaise with clinical research associate conducting monitoring activities on behalf of sponsors of

clinical trials r. Have sound knowledge on ICH/GCP guidelines

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1 Tyer, J.H., Eadie, M.J., Sutherland, J.M., Hooper,

W.D., Outbreak of anticonvalsant intoxication in an

Australian city. Brit. Med. J. 4, 271-273 (1970)

2

No.21, 18-21 (2006)

3 M-R Mueller, From delegation to specialization:

nurse and clinical trial co-ordination. Nursing

Inquiry 8: 182 – 190 (2001)

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