Documentation of Consent & Process
Once a fully executed (signed and dated by all parties) informed consent form is obtained, a copy of the entire document should be given to the participant. The participant should keep this copy for future reference. The entire original document must be retained by the researcher.
For some clinical trials, sponsors require additional documentation. They often require that the discussion with the participant regarding potential participation and the informed consent process be documented as well. This can be captured during a study visit in the physician’s note or documented in the subject’s research record. Documenting the consent process is a good practice for all research.
Example of a note to the research record which documents the informed consent process:
“07/07/2004: Study participation for protocol 03-4567
was discussed today w/ Ms. Jane Doe. Study treatment, risks, benefits, and
alternatives were part of that discussion. She read through the consent
form and after all of her questions were answered she decided to participate.
We signed the consent form and a copy was given to the subject today. She
will be scheduled for the appropriate research related tests and will begin
treatment thereafter.
- Dr. Doolittle”