Get Form A Multi Site Study (.pdf) - Famu

Filling out the Form A Multi Site Study is a crucial step for researchers conducting studies across multiple sites. This guide provides clear instructions to help users complete the form accurately and efficiently.

Follow the steps to successfully fill out the form.

1. To obtain the form, click the ‘Get Form’ button to access the document and open it in the appropriate application.
2. Begin by entering your project title in the designated field at the top of the form, ensuring it accurately reflects the focus of your research.
3. Provide the principal investigator's name, phone number, and email address in the specified sections to ensure proper communication regarding the study.
4. In the first section, list the names and locations of all participating centers. If applicable, include the Federalwide Assurance (FWA) number for each site involved.
5. Next, detail the names, qualifications, and contact information for all principal investigators at each participating site, ensuring that this information is complete and correct.
6. Describe the procedures for coordinating participant enrollment and randomization for the overall project to clarify the structure of the study.
7. Outline the process for data submission and specify the schedule for when data will be submitted, which is critical for maintaining study timelines.
8. Explain how serious adverse events and unanticipated problems will be reported to the overall study director at FAMU, including the timeframe for these reports.
9. Discuss the plan for regular communication between the overall study director and other sites, as consistent communication is key for a successful multi-site study.
10. Elaborate on the on-site auditing and monitoring plan for each participating site to ensure compliance and quality control throughout the study.
11. Provide a data safety monitoring plan that outlines how data integrity and participant safety will be protected during the study conduct.
12. If applicable, define any centralized components of the study and explain how samples, data, and imaging studies will be sent to the central site, detailing what will be done with these items.
13. After completing all sections of the form, review the entries for accuracy. You can then save changes, download, print, or share the form as needed.

Ensure all documents are completed accurately online to facilitate a smooth review process.