Get the free Clinical Investigation Agreement template

This document outlines the agreement between the IRCCS Azienda Ospedaliero-Universitaria di Bologna and the Sponsor, detailing the execution of a clinical trial, including roles, responsibilities, conditions for conducting the trial, patient safety measures, insurance, and data protection protocols.

How to fill out clinical investigation agreement template

How to fill out clinical investigation agreement

1. Begin by identifying the parties involved in the agreement, including the sponsor and the clinical site.
2. Clearly define the objectives and purpose of the clinical investigation.
3. Outline the roles and responsibilities of each party for the duration of the investigation.
4. Include details about the study protocol, including procedures, timelines, and any specific methodologies.
5. Specify the budget and funding arrangements, detailing how expenses will be managed.
6. Establish terms for data management, ownership, and confidentiality agreements.
7. Include clauses related to publication rights and sharing of results.
8. Define the duration of the agreement and conditions for termination.
9. Ensure compliance with relevant regulations and ethical guidelines.
10. Have all parties review and sign the agreement to formalize it.

Who needs clinical investigation agreement?

1. sponsors of clinical trials, such as pharmaceutical companies or research institutions,
2. clinical research organizations (CROs) managing the trials,
3. clinical sites conducting the trials, such as hospitals and clinics,
4. regulatory bodies requiring documentation for compliance,
5. investigators who need clarity on their responsibilities and rights.

What is Clinical Investigation Agreement Form?

The Clinical Investigation Agreement is a Word document required to be submitted to the relevant address in order to provide specific information. It has to be completed and signed, which is possible manually, or with a certain solution like PDFfiller. This tool lets you fill out any PDF or Word document directly from your browser (no software requred), customize it depending on your requirements and put a legally-binding e-signature. Right away after completion, the user can send the Clinical Investigation Agreement to the appropriate recipient, or multiple ones via email or fax. The template is printable as well thanks to PDFfiller feature and options offered for printing out adjustment. In both electronic and in hard copy, your form will have a clean and professional appearance. You can also save it as the template to use later, without creating a new document over and over. All that needed is to customize the ready sample.

Clinical Investigation Agreement template instructions

Once you're about filling out Clinical Investigation Agreement Word form, make sure that you prepared all the necessary information. That's a mandatory part, since some typos can cause unpleasant consequences from re-submission of the full blank and finishing with missing deadlines and you might be charged a penalty fee. You should be really observative when writing down figures. At first sight, this task seems to be quite simple. Nevertheless, it's easy to make a mistake. Some use some sort of a lifehack keeping their records in another document or a record book and then add this information into documents' sample. Nevertheless, come up with all efforts and present actual and solid data in Clinical Investigation Agreement .doc form, and doublecheck it during the process of filling out all required fields. If it appears that some mistakes still persist, you can easily make amends when working with PDFfiller application without blowing deadlines.

How to fill Clinical Investigation Agreement word template

As a way to start completing the form Clinical Investigation Agreement, you will need a blank. When you use PDFfiller for filling out and filing, you may get it in several ways:

• Get the Clinical Investigation Agreement form in PDFfiller’s library.
• You can also upload the template via your device in Word or PDF format.
• Finally, you can create a document to meet your specific purposes in creator tool adding all required fields in the editor.

Whatever option you choose, you'll get all editing tools at your disposal. The difference is, the form from the catalogue contains the necessary fillable fields, you need to create them on your own in the rest 2 options. Nonetheless, this procedure is dead simple and makes your form really convenient to fill out. These fillable fields can be easily placed on the pages, and also deleted. There are many types of them depending on their functions, whether you are entering text, date, or put checkmarks. There is also a e-signature field if you need the writable document to be signed by other people. You also can put your own e-sign with the help of the signing tool. Upon the completion, all you have to do is press Done and proceed to the submission of the form.

For pdfFiller’s FAQs

How do I edit clinical investigation agreement template online?

With pdfFiller, it's easy to make changes. Open your clinical investigation agreement template in the editor, which is very easy to use and understand. When you go there, you'll be able to black out and change text, write and erase, add images, draw lines, arrows, and more. You can also add sticky notes and text boxes.

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

clinical investigation agreement template can be edited, filled out, and signed with the pdfFiller Google Chrome Extension. You can open the editor right from a Google search page with just one click. Fillable documents can be done on any web-connected device without leaving Chrome.

Can I create an eSignature for the clinical investigation agreement template in Gmail?

Create your eSignature using pdfFiller and then eSign your clinical investigation agreement template immediately from your email with pdfFiller's Gmail add-on. To keep your signatures and signed papers, you must create an account.

What is clinical investigation agreement?

A clinical investigation agreement (CIA) is a contract between a sponsor and an investigator that outlines the responsibilities of both parties regarding the conduct of a clinical trial.

Who is required to file clinical investigation agreement?

Sponsors of clinical trials, such as pharmaceutical companies or research institutions, are typically required to file a clinical investigation agreement.

How to fill out clinical investigation agreement?

To fill out a clinical investigation agreement, complete all required sections including details about the study, responsibilities, payments, and provide necessary signatures from both the sponsor and investigator.

What is the purpose of clinical investigation agreement?

The purpose of a clinical investigation agreement is to ensure that both the sponsor and the investigator are clear about their obligations, rights, and the conduct of the clinical trial.

What information must be reported on clinical investigation agreement?

The information that must be reported includes the study title, objectives, responsibilities of parties, financial terms, and compliance with regulatory requirements.