Get the free Clinical Investigation Plan Template - FDA

Clinical Investigation Plan Cover Agency Number: NCT02757430 Onsite Precision V2.0 Registry Redacted Clinical Investigation Plan Study Document No: ABTCIP10269 (reference #SJMCIP10111) Version B Date:

How to fill out clinical investigation plan template

How to fill out clinical investigation plan template

1. To fill out a clinical investigation plan template, follow these steps:
2. Start by providing the title and version of the clinical investigation plan.
3. Fill out the table of contents with the different sections and subsections of the plan.
4. Begin the introduction section by providing background information on the investigation and its objectives.
5. Describe the investigational product, including its composition and characteristics.
6. Outline the study design and methodology, including the population to be investigated and the inclusion and exclusion criteria.
7. Provide details on the primary and secondary endpoints of the investigation.
8. Describe the statistical methods and sample size calculations to be used.
9. Explain the study procedures, including data collection methods, assessments, and follow-up visits.
10. Specify the safety monitoring and adverse event reporting procedures.
11. Outline the data management and analysis plan.
12. Provide information on the study timeline and milestones.
13. Discuss the ethical considerations and informed consent process.
14. Include details on the resources and budget required for the investigation.
15. Summarize the plan with a conclusion section.
16. Review the completed template for accuracy and completeness before finalizing it.

Who needs clinical investigation plan template?

1. Any organization or individual involved in conducting clinical investigations needs a clinical investigation plan template. This includes pharmaceutical companies, medical device manufacturers, academic research institutions, and contract research organizations. The template helps ensure that all necessary information is included in the plan and facilitates consistent documentation across different investigations.

For pdfFiller’s FAQs

How do I make edits in clinical investigation plan template without leaving Chrome?

Install the pdfFiller Google Chrome Extension in your web browser to begin editing clinical investigation plan template and other documents right from a Google search page. When you examine your documents in Chrome, you may make changes to them. With pdfFiller, you can create fillable documents and update existing PDFs from any internet-connected device.

How can I fill out clinical investigation plan template on an iOS device?

Install the pdfFiller app on your iOS device to fill out papers. If you have a subscription to the service, create an account or log in to an existing one. After completing the registration process, upload your clinical investigation plan template. You may now use pdfFiller's advanced features, such as adding fillable fields and eSigning documents, and accessing them from any device, wherever you are.

How do I edit clinical investigation plan template on an Android device?

With the pdfFiller mobile app for Android, you may make modifications to PDF files such as clinical investigation plan template. Documents may be edited, signed, and sent directly from your mobile device. Install the app and you'll be able to manage your documents from anywhere.

What is clinical investigation plan template?

The clinical investigation plan template is a document outlining the detailed plan for conducting a clinical trial.

Who is required to file clinical investigation plan template?

The sponsor of the clinical trial is required to file the clinical investigation plan template.

How to fill out clinical investigation plan template?

The clinical investigation plan template must be filled out with all the necessary details of the trial protocol, study objectives, methodology, and other required information.

What is the purpose of clinical investigation plan template?

The purpose of the clinical investigation plan template is to provide a structured outline of how the clinical trial will be conducted and to ensure the trial meets ethical and regulatory requirements.

What information must be reported on clinical investigation plan template?

The clinical investigation plan template must include details on the trial protocol, study objectives, methodology, subject selection criteria, and safety monitoring procedures.