Trial managment

This section contains the following:


The trial management plan should include an outline of the arrangements for the day-to-day running of the trial (Trial Co-ordinating Center), the supervision of the trial (Trial Steering Group) and monitoring of the trial (Data Monitoring and Safety Committee).  It should also describe who will be responsible for essential activities, such as staff recruitment, supplying treatment, and data management.  The management plan should set achievable targets (see Gantt chart tool), provide the framework for building an enthusiastic and efficient team, and detail and justify the necessary resources for delivering a successful trial.

Trial Co-ordinating Center
Any substantial trial requires a Trial Co-ordinating Center to handle administrative matters once participants are being entered.  This is usually the base for the Trial Management Group.  A typical Trial Management Group consists of: principal investigator; trial manager; trial programmer; database manager and/or data clerks; trial statistician (or consultant); and trial secretary.  This group should meet regularly e.g. weekly to ensure the efficient day-to-day running of the trial, to prepare reports for the steering committee, and to organize and service the data monitoring and ethics committee.  The essential activities of the Trial Co-ordinating Center may include:

Trial Steering Group
The Trial Steering Group should meet periodically to discuss the overall progress of the trial.  It should include the principal investigator, trial manager, one or two experienced investigators not otherwise involved in the trial, and a statistician.  The group should meet initially to finalize the protocol and organization.  Once the trial is running the group should meet  regularly e.g 6–monthly to discuss issues such as: recruitment progress; protocol deviations; possible protocol amendments; and interim results.  The Trial Steering Group should operate in an advisory capacity leaving the principal investigator to implement any decisions.

The Data Monitoring Committee
The principal role of the Data Monitoring Committee is to monitor data and alert the organizers of the trial if they think the pattern of data – on benefits or hazards or both – is sufficiently persuasive to warrant either closing recruitment to a trial or changing the protocol, such as terminating recruitment in one or more sub-groups of trial participants.  The Data Monitoring Committee should be completely independent of the Trial and should meet regularly (e.g. annually) to review interim results.

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Things to consider when writing a protocol

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Illustrative example - Perinatal care trial

Study Organization
Duties of the Research Units
CLAP will be the coordinating center for the study. The study coordinator based at CLAP will work with three country coordinators. There will be one country coordinator for each of the following regions: The Province of Buenos Aires, the City of Rosario, and the Department of Montevideo. Each country coordinator will supervise hospital data collectors. A data manager and data entry clerks will also be based at CLAP. The U.S. investigators will support the coordination of the study by distance communications and by frequent in-country visits.

The trial will be directed by a Steering Committee including the Principal Investigator, the Senior Foreign Investigator, CLAP study coordinator, the Statistician, Data Manager, one Data Center representative, and one NICHD representative. The Steering Committee will meet annually, or more frequently as needed. The Steering Committee will be informed on a regular basis of the progress of the study and will provide regular feedback to the investigators and CLAP study coordinators.

Duties of the Data Coordinating Center
The Data Center will provide research support services to the Global Network. These will include establishment and maintenance of a centralized information management system to help the Global Network Research Units collect, edit, store, analyze, publish, and disseminate results from their individual projects as well as from shared research. It will assist the program staff of the NICHD and other cosponsoring NIH Institutes and Centers (ICs) in monitoring research progress and will work to ensure data integrity, accuracy, and accessibility among all Research Unit sites. It will offer technical assistance and analytical support for all sites, as needed. The Data Center will provide particular attention to the needs of developing country sites for the purpose of helping develop and enhance their capacity for data collection and analysis. Initially, the Data Center will support primarily the individual research projects undertaken by Global Network Research Units. However, as the Network becomes more established and the capacity of the Research Units to undertake common protocols is strengthened, the Data Center must be prepared to respond to the needs of shared research projects.

All activities of the Data Center must be closely coordinated with the NICHD Staff Science Coordinator. In support of all research projects undertaken by the Global Network, the Data Center staff will do the following:

  • Support the activities of the Network Advisory Group, Steering Committee, and the DSMB through provision of materials/documentation support, meeting planning and logistics, and conference call coordination.

  • Provide advice on study design, data collection, data analysis, and publication development to all Global Network research projects.

  • Prepare, design, and disseminate operations manuals, data collection forms, databases, and results reporting summaries for Global Network research projects.

  • Compile for the Network Advisory Group and Steering Committee, the DSMB, the NICHD, and the other participating NIH ICs site visit reports, monthly and quarterly subject enrollment reports, meeting summaries, quarterly Research Unit performance and progress reports, and other reports as needed.

  • Maintain or assure maintenance of high quality databases resulting from any collaborative research, supervise all data collection procedures, and arrange for the most efficient transfer of study data where indicated.

  • Ensure that all Global Network sites and investigators fully comply with NIH regulatory requirements, including informed consent, reporting of adverse events, human and animal subject safety and welfare provisions, and the requirements of international collaboration.

  • Provide training to all Research Unit site personnel as needed on data management and analysis, quality control, and quality assurance.

  • In coordination with the NIH cosponsors, provide periodic on-site monitoring to the Research Units for those studies being performed at that site.

(CLAP Trial - go to protocol)

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Illustrative example - Magpie trial

Magpie Trial Steering Committee The overall progress of the trial will be monitored by a scientific and administrative steering committee. The membership of this committee is: Rory Collins, Lelia Duley, Edmund Hey, Richard Lilford, Jack Moodley, James Neilson, Stephen Robson, Peter Rubin (Chair), James Thornton, Sara Twaddle, and Isabel Walker. Observers are Marc de Bruycker, Barbara Farrell, Marian Kelly and José Villar. The UK Medical Research Council convenes this committee.

Magpie Trial Management Group This group will meet every 2-3 months to assist with day to day running of the trial, and to prepare reports for the steering committee. Membership: Mike Clarke, Lelia Duley, Barbara Farrell (Chair), James Neilson, Jane Notman and Patsy Spark.

Data Monitoring Group The terms of reference of the data monitoring committee are outlined earlier. The membership of this committee is: Richard Doll (Chair), Adrian Grant (Vice Chair), Naren Patel, Jimmy Volmink and Godfrey Walker.

International Advisory Board An International Advisory Board has been convened to advise the Magpie Trial Management Group, as and when requested. This board has a multidisciplinary membership from around the world.

(MAGPIE Trial - go to protocol)

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Illustrative example - INIS trial

Trial Steering Committee

The Trial Steering Committee (TSC) provides overall supervision of the trial on behalf of the Medical Research Council. Its terms of reference are:

1. To monitor and supervise the progress of the trial towards its interim and overall objectives.

2. To review at regular intervals relevant information from other sources (e.g. related trials).

3. To consider the recommendations of the Data Monitoring and Ethics Committee.

4. In the light of 1, 2 and 3 above, to inform the MRC Council and relevant MRC Research Boards on the progress of the trial.

5. To advise the MRC Council on publicity and the presentation of all aspects of the trial.

Meetings of the TSC will take place at least once per year.

Investigators’ Group

The Investigators’ Group will consist of the trial investigators, representatives of specific groups whose expertise is necessary for the trial, and investigators of any ancillary studies. This group will supervise the practical aspects of the trial’s conduct. It will resolve problems brought to it by the Project Management Group (see below) and will be responsible for organising reporting and dissemination of the trial’s results.

Project Management Group

The Project Management Group (PMG) will oversee the day-to-day running of the trial. The responsibilities of the Project Management Group include:

i) recruitment of participating centers

ii) distribution and supply of data collection forms and other appropriate documentation for the trial

iii) data collection and management

iv) organization of the distribution system for the treatment packs

v) organization of the follow-up of children at 2 years if age, including the distribution of questionnaires, follow-up of non-responders and liaison with local ‘follow-up’ personnel

vi) data entry and cleaning

vii) data analysis

viii) collection of adverse event data

ix) organizing and servicing the Data Monitoring and Ethics Committee.

(INIS Trial - go to protocol)

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Additional resources

Trial Protocol Tool resource iconA Gantt chart tool

This is an easy to use tool that provides a graphical illustration of a schedule that helps to plan, coordinate, and track specific tasks in a project.

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Trial Protocol Tool resource iconChecklist – A typical trial co-ordination team

This checklist has been contributed by Barbara Farrell who prepared it for the second version of the Trial Management Guide.

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Trial Protocol Tool resource iconIntervention, follow-up and protocol adherence text from 3rd edition of Clinical Epidemiology

This text has been contributed by Dave Sackett, who prepared it for the forthcoming 3rd edition of Clinical Epidemiology; A Basic Science for Answering Questions about Health Care, to be published by Lippincott, Williams & Wilkins in 2005.

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Web resource iconEfficient management of randomised controlled trials: nature or nurture

Barbara Farrell. Efficient management of randomised controlled trials: nature or nurture. BMJ 1998;317:1236–9

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Web resource icon Resource Centre for Randomised Trials

The Resource Centre for Randomised Trials (RCRT) aims to provide a central and generic archive of resources relevant to the process of developing and doing trials.  This will help maximise the overall investment made in trials.  To ensure ease of access, whenever feasible the materials within this library will be accessible via a website that is regularly updated. 

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Web resource iconTrialsCentral

TrialsCentral provides free and confidential access to listings of clinical trials. Information about current clinical research helps support informed evidence-based decision making in healthcare.  The RESOURCES page links to health care information sites, including medical dictionaries, articles, and links to other evidence-based health care sites.

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Web resource iconThe Society for Clinical Trials

The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design and conduct of clinical trials and related health care research methodologies.

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Web resource iconMRC Trial Managers Network

The MRC Trial Managers Network is a forum for all MRC funded trials. Its primary functions are to link trial managers together to ensure the dissemination of expertise and experience and to provide training tools developed by the members of the network.

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Further reading

Warlow CP. How to do it: organize a multicentre trial. BMJ 1990;300:180-3

Pocock SJ. Clinical Trials: A Practical Approach. John Wiley and Sons, Chichester, 1983.

Ellenberg SS, Fleming TR, DeMets DL.  Data monitoring committees in clinical trials. a practical perspective.  Chichester: John Wiley and Sons, 2003.

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This page was last updated 11th September 2007.