What Does Informed Consent Document Preparation Include?
Sterling IRB prepares informed consent documents for sponsors, CROs, and investigators who want to outsource the technical writing and editing. Our team reviews consent materials every day as an IRB, so we prepare documents with the board’s expectations in mind from the first draft. Services include:
- Informed consent, parental permission, and assent documents for adult and pediatric studies
- Concise key information sections that reflect current FDA and OHRP draft guidance
- Plain-language writing that accounts for varying levels of health literacy
- eConsent solutions for decentralized and hybrid trials, with attention to 21 CFR Part 11 identity verification requirements
- Certified translation services for informed consent documents
Supporting Informed Consent From First Conversation to Final Visit
Informed consent in clinical trials starts with the document and continues through every interaction with a participant. Our board evaluates the full consent process: how research teams use key information to open a discussion, how they confirm comprehension through methods like teach-back, and how multimedia and eConsent tools help participants review details at their own pace. As studies change, we review revised consent materials so participants stay informed through every amendment.
For more information, please contact:
Kathye Richards, CIP
Vice President of Client Services, Institutional Official