Toolbox

Part 11 Compliance

Electronic Signatures & Documents Compliance

Informed Consent

Informed Consent for Clinical Trial Subject Recruitment

Enrollment Note

What is an Enrollment Note for Informed Consent

Waiver of Informed Consent

IRB Waives the Need to Obtain Informed Consent

Toolbox

eConsent

Modernizing the Informed Consent Process

Research with Genetics

Conducting Genetic and Genomic Research

Compensating Subjects

Guidelines on Compensating Human Research Subjects

Registries and Repositories

Storage of Information and Biological Specimens

Toolbox

SRB vs. IRB

Scientific Review Board & Institutional Review Board

Blood Draw Considerations

Human Subject Protection and IRB Consideration

Special Populations

Characteristics of  Special and Vulnerable Populations

Dataset Selection

Determining Appropriate Data Type and Source