Box 82 Format of a typical trial launch meeting

♦ The principal investigator welcomes everyone to the meeting and introduces the members of the trial management group, indicating the role of each

♦ The principal investigator reminds people of the importance and timeliness of the trial

♦ The expert advisers explain their roles

♦ The medical statistician and clinical trials manager emphasize important aspects of the design of the trial and data management

♦ The meeting is opened to discussion, comments and queries

♦ Members of the coordinating staff provide centres with protocols, sets of forms, and publicity material for promoting the trial among their colleagues. These may include sets of slides or a PowerPoint presentation describing the trial

♦ Where appropriate, members of the coordinating staff start arranging dates for visiting centres to recruit them to the trial visit all centres before starting a new trial because some will already be familiar with the general procedures and requirements for collaboration, and trial-specific operating procedures can be dealt with by telephone and correspondence. If, however, a centre is new to collaborating in trials or there are trial-specific procedures that require special attention, an appropriate member of the group should visit a centre before it starts randomizing patients. It is the responsibility of the trial management group to ensure that in all collaborating centres all procedures are fully understood and that the local staff responsible for the trial are identified, are conversant with the protocol, and are fully aware of their responsibilities before the first patient is randomized.

By agreeing to take part in a trial, clinicians undertake to conduct the trial in their own centre in accordance with the protocol and to provide the data required. They should pay particular attention to the following issues.

♦ Adhere to the trial protocol.

♦ Ensure that the requirements for freely given, fully informed consent are adhered to.

♦ Arrange for the patients to be assessed at the times stipulated in the protocol.

♦ Ensure that any patient questionnaires, such as quality of life questionnaires, are completed by patients at the times stipulated and that all questions are answered.

♦ Ensure that forms are filled in clearly, legibly and completely, and that queries are answered promptly.

♦ Cooperate in any source data verification that may be required.

♦ Contact the principal investigators or trials coordinating staff about any queries or concerns.

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