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For example, list the demographic criteria, required laboratory data, any prior therapies allowed or disallowed, ability to understand and meet all study requirements, if contraception is necessary, exclusion criteria such as specific health status, use of excluded drugs, cancer status, and chemical dependency status.
Selection and Exclusion of Subjects: Provide statements describing how the participants must meet all the inclusion and exclusion criteria, and list the criteria. This should include the type of study, primary and secondary outcome(s), population, sample size, study location, period of enrollment and follow-up, intervention and route of administration, randomization (as necessary), and any other relevant protocol information. Study Design: Describe the methodology and how it will answer the study question. Include the name and description of the proposed intervention, including the dosage, route of administration, period, and frequency of intervention. Include data from other studies relevant to this proposed research. Include the medical and scientific rationale that justifies researching the problem. Background Information: Describe the problem under study and priority. Objectives: List the study’s primary and secondary objectives. They also detail the study team and site, particularly in the case of multiple teams and sites. The pages include the principal investigator’s signature (or sponsor), as well as site-specific information, such as the agreement, and protocol details. #Free clinical trials nih trial
Title Pages: These pages provide general information about the protocol, including name, number, version number and date, trial phase, investigational product name, investigational new drug (IND) number, sponsor (or principal investigator in academia), funding organization, medical monitor, and coordinating center.
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The full research protocol includes the following sections and topics:
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Download Research Protocol Template - Word
Improve Clinical Trial Research with Smartsheet for Healthcare. Public Links and Resources for Clinical Trials. Post-Clinical Study Research Documentation and Templates. Eligibility Criteria (Inclusion/Exclusion) Checklist. Enrollment Log for Clinical Trials Template. 
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