Informed Consent Process Record
Consent record covering what a monitor actually reconstructs: form version against its approval date, who conducted the discussion and whether they were delegated to, time allowed, an explicit sequence check that no trial procedure preceded the signature and that the participant dated it personally, the process note, and re-consent tracked with an outstanding column. Maps to 21 CFR Part 50 and ICH E6(R3).
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
Consent is the one procedure where the regulatory and the ethical obligation are the same thing, and it remains among the most frequently cited deficiencies in clinical inspections. The failures are almost never about the form itself — they are about what happened around the signature: the version used, who conducted the discussion, whether they were delegated to do it, and what preceded it.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
21 CFR Part 50 sets the US informed-consent requirements, including the required elements, documentation, and the rule that consent precedes any research procedure; ICH E6(R3) sets the good clinical practice expectations for the consent process and for re-consent when new information arises. Neither decides how much time a participant needs, which staff may take consent at your site, or what a process note must contain — those are the investigator’s determinations. The record structure is SPEQ synthesis.