Guidance Documents
Below are guidance documents we hope you will find useful.
Clinical Trial Contract Submission Guidance
Comparison of ICH and FDA Regulations
Investigator Responsibilities Guidance
Noncompliance: Addressing Research Noncompliance - Guidelines for Departments and Practices
Procedure for Observation of the Informed Consent Process
Protocol Template Guidance: Biomedical Research Sample #1
Protocol Template Guidance: Biomedical Research Sample #2
Protocol Template Guidance: Data Coordinating Center
Protocol Template Guidance: Lead Coordinating Center
Protocol Template Guidance: Social Science/ Behavorial/ Educational Research
Regulatory File: Essential Documents
Research Recordkeeping and Retention Requirements
Research Record Keeping and Retention: Administrative Records Relating to Research
Roles and Responsibilities Documentation
Physician Initiated Investigational New Drug (IND) or Device Exemption (IDE)
FDA Regulated Product - Adhering to Federal Regulations
Investigational New Drug (IND) Sponsor - Investigator Responsibilities
Physician/Investigator as Sponsor of an IDE - Non Significant Risk Device
Physician/Investigator as Sponsor of an IDE - Significant Risk Device