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Titlebook: Developing a Successful Clinical Research Program; Cara East Book 2018 Springer International Publishing AG, part of Springer Nature 2018

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Developing a Budget,. Then for the specific study, an estimate of how many months the study will take and what percentage of the team’s time will be attributed to it should be developed. This provides a rough guess but can be used together with the science of the study and the contract to decide if participation in the
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Negotiating a Contract,ite, and/or the institution for the conduct of the clinical research trial. Responsibilities of the site include maintaining staff certifications and documentation, agreeing to follow the details of the protocol, obtaining appropriate subject consent, and providing all needed documents to the instit
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Writing a Great Consent,hould ask questions at any time. Research participants should be referred to as “subjects” to emphasize that they may not receive direct benefit from participating in the trial. More time should be spent on the consent process that on almost any other procedure in the trial. “If you take a medicine,
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Starting the Study,review the study procedures. The team members should have already read the protocol, consent, and prescreening form. Then, immediately before the first subject is enrolled, the team should have a mock subject drill. After enrolling the first subject, a Study Update Meeting should be scheduled to deb
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Recruiting,ng that start-up costs are the same regardless of which goal is met. Flyers for medical facilities have a modicum of success as do giving presentations at medical speaking events, booths at health fairs or senior centers, or discussions at medical staff in-services. Referral letters to physicians ca
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The Screening Visit,be collected. For future follow-up, all phone numbers, email addresses, names of four friends and family members, and names and contact information for physicians should be listed. A picture of the subject (which may be on a driver’s license) and a medical release form should be completed. The medic
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