Informational Programs for Site Staff Conducting Clinical Research
The following site management modules were created in collaboration with TransCelerate BioPharma to simplify and enhance the clinical trial site qualification and training process.
The program describes the basic concepts of clinical research in accordance with the ICH Guideline for Good Clinical Practice: Consolidated Guidance (E6).
Updates and new tools are added continually.
Principal Investigator Oversight Informational Program
Informational program outlining the basic components related to Principal Investigator oversight of clinical trials
IRB/IEC Responsibilities and Informed Consent
Overview of the purpose and activities of the IRB/IEC and the Investigator’s responsibilities in accordance with ICH-GCP. Describes the process of informed consent and the responsibilities of the Investigator when obtaining informed consent.
Run Time: 30 minutes
A review of the terms source data and source documents. Describes the key attributes of source documents, the intent of ALCOA and CCEA and describes the appropriate processes for creating, maintaining and storing source documents.
Run Time: 20 minutes
ICH E6 R2 Update Source Documentation
Essential Documents for a Clinical Study
Describes the requirements for Clinical Study essential documents. Describes the type of essential documents collected for a Clinical Study during the different study phases.
Run Time: 20 minutes
ICH E6 R2 Update Essential Documents for Clinical Study Module
One delegation log for sites to use with consistent named tasks and clear instructions.
Site Signature and Delegation of Responsibilities Log Guidance
*The following are preferred settings to view the Informational Programs:
• Primary and secondary browser combinations: Internet Explorer 9+, Chrome 40+, Safari 7, Firefox 17+
• Primary and secondary OS: Windows 8.8 and for Mac OS X
• Primary and secondary devices: Windows and Mac laptops and desktops, iPads, Topics can be accessed through all these devices, including iPads. The only restriction on iPad is that there is no effect of mouse-over/hover-over. Search functionality may not be replicated on iPads