NCIC CTG Central Office Structure/Functions


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Organizational Structure

1.5.1 - Overview

The Clinical Trials Group is a major programme of the NCIC while an independent research group is responsible to the NCIC in that it is obliged to follow the policies of the NCIC and must account to the NCIC for the expenditure of awarded funds. However, in the interval between reviews, the NCIC has no role in determining what studies the group will undertake. Recommendations concerning research directions and funding are made at review time. It is the responsibility of the Advisory Committee on Research (ACOR) of the NCIC to refer site review recommendations to the board of the NCIC for final approval.

1.5.2 - Central Office Structure and Function

As was mentioned in the description of the history of the Group, the central office functions both as an operations office and a statistics office. This means central office staff are responsible for all organizational aspects of NCIC CTG trials, and as well for receiving, reviewing, storing, and analyzing all data on study patients. Data Management functions are described more fully in the CRA Manual.

1.5.2.1 - Physician Coordinator

The physician coordinator functions essentially as an in-house partner of the study chair. He or she shares the responsibility for medical input into the development, execution, and analysis of a study. The physician coordinator's most evident role during the conduct of a study is to adjudicate, in consultation with the study chair, questions of eligibility, response, outcome, and so on.

The Director, plus the Director and Co-Director of the IND Program all function as physician coordinators to varying extents, in addition to the physician(s) hired expressly for this purpose. As well, Fellows -- physician research trainees supported by the NCIC-- may function as physician coordinators or study coordinators for trials.

1.5.2.2 - Study Coordinator

The study coordinator has the primary responsibility for ensuring the success of the trial. He or she assists in protocol and forms design and development, coordinates the activation process and, during the trial, reviews all submitted data, assessing them for completeness and compliance with protocol requirements. The study coordinator establishes and maintains the trial database, ensuring the coherence and accuracy of all data retrieval, and is responsible for monitoring the trial for unexpected trends which might compromise trial integrity and initiating mechanisms for solutions.

Throughout a trial, the study coordinator is the primary central office contact for participants and relevant external agencies. She or he promotes quality assurance through regular liaison with clinical research associates, circulation of explanatory trial-related material, and educational sessions.

1.5.2.3 - Research Associate

The research associate participates as an integral member of the study team in the coordination and conduct of a trial. He or she is involved in such activities as the design and development of the protocol and CRF, site activation, monitors database accuracy, coordinates Quality Assurance checks and performs data validation for the study to ensure the data validation processes are consistent, accurate and timely. The research associate generates queries, participates in query resolution, develops study-related newsletters, pocket cards and liaises between data entry staff, site personnel and the study team.

1.5.2.4 - Clinical Trials Assistant

Clinical trials assistants are responsible for registration/ randomization of patients on study, initial review of incoming forms, data entry, trial related correspondence, drug shipping, and so on. In general, study coordinators and clinical trials assistants are paired so they form a team throughout the conduct of a trial.

1.5.2.5 - Data Entry Clerk

Data Entry Clerks are involved in the preliminary review, verification and querying of data received. They input data directly into complex databases, interpret and code toxicities, medications, therapies and sites of disease.

1.5.2.6 - Biostatistics/Computing

Development of data entry and data management procedures and statistical analyses for NCIC CTG trials are carried out by "computing" staff under the overall supervision of the senior biostatisticians and the Information Technology Manager. This team consists of systems managers, oracle programmers, SAS programmers and biostatiscians.

The senior biostatisticians take an active role in protocol development, advising on study design and statistical methodology. They also have final responsibility for formal analyses of trials.

1.5.2.7 - Quality Assurance Office

The Quality Assurance Office oversees the site audit programme and the centre performance index, and is responsible for ensuring quality control in NCIC CTG data handling.

1.5.2.8 - Ethics, Regulatory and Intergroup Affairs Office

The ERI Office focusses on the following areas: the ethical conduct of trials including appropriate Research Ethics Board approval and consent issues; the conduct of Group studies according to Good Clinical Practice Guidelines; CTA submissions, protocol amendments and safety reports to Canadian and U.S. regulatory authorities; serious adverse event reporting; administrative aspects of trial conduct including trial activation requirements, protocol amendments/revisions, centre study files; standard operating procedures for the development and conduct of intergroup trials.

1.5.2.9 - Operations Office

This office is responsible for a wide variety of internal and external administrative activities including ensuring that our roster of centres and committee members is up to date and accurate and in accord with group policies; human resources management and finances, and meeting coordination, i.e. annual, committee, and start up meetings.

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