Study Related Documents
Here at ICRS we cannot stress enough the importance of Good Documentation Practices. ICRS will help you to keep your Regulatory Binder up to date and organize its content in accordance with the FDA, GCP, and other industry regulations and guidelines.
We can create blank copies of the following documents:
– Case Report Forms
– Subject Logs
– Participant Information Sheets
– Source Documents
– Screening, Enrollment Logs
– Recruitment, Randomization Logs
– Study document
– Serious Adverse Event Form/Safety Report
– IRB submission Tracking Log
– Investigational Product Accountability Log
– Specimen Tracking Log
– Delegation of Authority Log
– Other