Reporting Requirements

Does your organization utilize your in-house reporting teams and systems to their full potential? Learn how a standardized business intelligence system could complement your current reporting structure to improve your organization’s operations.

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.

Checking the box is still an option on the FWA. At this time, institutions must carefully consider whether it makes sense to check the box.

In investigator-initiated trials, an investigator takes on the clinical study as both the sponsor and investigator. Learn more about IITs impact on the clinical research industry.

Find out more about what to report to whom--and when--in the Q&A blog follow-up to our recent webinar. Read the answers to popular audience questions:

COVID-19 complicates traditional models of community consultation. How should sites conducting planned emergency research approach community consultation?

Audits to support your vendor qualification and management program should be conducted using a risk-based approach. Read more:

When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs: