The study logs and templates are intended to help research teams organize study documents, document required information and track study procedures with the aim to prevent common study errors and mistakes.
Good Clinical Practices Policies
Physician Initiated Investigational New Drug (IND) or Device Exemption (IDE)
An Individual or group of individuals or medical center can be considered a sponsor for an investigation if they hold the IND or IDE. These studies are typically called Investigator Initiated Studies and may use an investigational drug or device or use an approved drug or device for investigational purposes.
The Research Education and Compliance Officer (email@example.com) will consult with any individual or group which requires obtaining an IND or IDE prior to the launch of the project.
Do I need an IND/IDE to do my research?
Principal Investigator Responsibilities require the PI to create, maintain and properly store study files or regulatory binders that contain the required study documents as outline in the GCP SOP 1103 (and associated Guidance Documents) entitled “Regulatory files and Subject Records”.
The Regulatory Binder will help PIs and research staff, identify, maintain and organize study documents and correspondence in one central location.