Clinical Study Management
This section includes Clinical Trial study management tools, templates, and guidance for investigator-sponsored clinical trials. For additional assistance with study management tools, please contact us at firstname.lastname@example.org.
Before You Begin The Clinical Trial
A protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a trial. The ICH Good Clinical Practice Guidelines specify some topics that should generally be included in a protocol. See the Sample Protocol Template when developing your protocol. Many of the NIH institutes have their own protocol templates. Examples are available at the NIAID website.
Budget development involves three components:
- Identifying the cost of all research items and services required for the study
- Assigning financial responsibility for all items and services; and
- Maintaining a process for recovering costs throughout the study.
Every investigator should have a clear financial management plan to adequately support their research endeavors. The plan should include a defined department process and a responsibility log which outlines the team members accountable for the process. Please review Clinical Trial Budgeting & Billing before starting your study.
When approached with an invitation to participate in a clinical trial, the investigator usually receives a copy of the protocol or a protocol synopsis. It is very important to carefully review and evaluate the protocol and determine if appropriate patient population and resources are available for successfully completing the trial. The Sample Feasibility Checklist gives you a list of questions that you should consider before agreeing to participate in a trial.
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