Informed Consent Development
Craft Comprehensive, Easy-to-Read ICFs
Ensure your clinical trial documentation is compliant while making study activation more efficient. A user-friendly informed consent form (ICF) can help ensure participants are properly informed and increase trial retention rates.
Advarra’s experts have the ability to translate a protocol document into a compliant and understandable consent document, allowing sites to enroll participants onto protocols quicker.
Our Services Include:
Translating Protocol Documents
Translate the protocol document into the necessary consent templates that meet federal regulations, ethical standards, and Advarra IRB best practices
Generating Consent Documents
Generate parental permission, minor assent, screening, sub-study consent documents, as necessary
Storing and Applying ICF Language
Store and apply customer-specific conduct information to speed template creation
Leveraging Advarra Experts
Access to internal domain experts that can assist with accurate and understandable risk section creation
Our ICF writing services help make early phase research more efficient.
Read our Related Resources
Informed Consent: When, Why, and How It’s Obtained
Aside from being a regulatory and ethical requirement, informed consent is a good way to ensure participant knowledge and develop a foundation trust between researcher and participant.
Informed Consent: 6 Approaches to Increase Participant Comprehension
Ensuring participants have appropriate knowledge of a study is a crucial goal of the informed consent process. This paper describes six research-based approaches for improving informed consent and supporting participants’ ...
10 Tips for Writing Compliant Participant Materials
Recruitment materials are a potential participant’s first introduction to the study, and post-consent materials can influence an individual’s decision about continued participation. It is important to adhere to the principles ...