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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 5

Bao gồm một phần về việc tuân thủ của bệnh nhân. Đây là một từ ngữ có thể: "Mỗi liên hệ với bệnh nhân nên được sử dụng để giáo dục, thúc đẩy và tăng cường tuân thủ. Cá nhân quan tâm chú ý của các thành viên của đội ngũ nhân viên của bạn cũng sẽ làm tăng bệnh nhân tuân thủ điều trị quy định | preferably by a videotape compact disk or DVD illustrating the procedure. Reporting of adverse events. What events are likely how they will be detected how they will be summarized how they will be reported. Include a section on patient compliance. Here is a possible wording Every patient contact should be used to educate motivate and reinforce compliance. Individualized caring attention by the members of your staff will also increase patient adherence to the prescribed therapy. Incorporate any sample instructions you want the physician to pass on to the patient. For example One pill is to be taken twice a day with meals. In the event that you forget to take a pill at the designated time please take it as soon as possible. If you miss a dose completely please do not double up on the dose but simply take your pill at the next regularly scheduled time. I d also like you to make a record of any doses you do miss and to give me the list the next time you are in the office. These instructions should be included as an appendix to the physician procedures manual in a form that lends itself to copying and distribution to patients. Laboratory Guidelines The laboratory guidelines prepared for each individual specialty laboratory should be as comprehensive as those provided to the physician. They should cover the preparation of the sample shipping and receiving and the particulars of the analysis and should be as detailed as possible. This latter section should be written only after receiving a preliminary description from the laboratory. Although it may seem foolish to create a document that merely parrots back the laboratory s own words the result is to create a contract and hopefully to ensure uniformity in technique throughout the length of the trials. INTERIM REPORTS Your interim reports consist of all reports that are essential to successful conduct of the study. Included are reports on enrollment submission of scheduled follow-up data adverse events and an ongoing .