Certified Clinical Research Associate (CCRA) Practice Exam 2026 – All-in-One Guide to Master Your Certification!

Returning a signed and dated consent form by fax is acceptable according to FDA guidance. The FDA allows for certain electronic and facsimile methods of obtaining informed consent as long as they meet specific regulatory requirements and ensure that the consent process is compliant with the applicable regulations. This provision is made to facilitate the consent process while maintaining the integrity and confidentiality of patient information.

In clinical research, it is essential to ensure that the informed consent process is thorough and that participants fully understand what they are consenting to. As long as the signed consent forms can be securely transmitted and properly maintained, faxing these documents can be an acceptable practice.

It's important to keep in mind that some institutions or ethics committees may have their own policies regarding the handling of consent forms. However, the FDA's guidance does provide the necessary flexibility to utilize faxed consent forms under certain conditions, making the chosen answer accurate in the context of regulatory standards.