In collaboration with TransCelerate BioPharma, Inc. the following site management modules are being offered to simplify and enhance the clinical trial site qualification and training process. Updates and new tools are continually added and you are invited to return as frequently as you’d like.
Informational Programs for Site Staff Conducting Clinical Research
This is an informational program focused on describing the basic concepts of Clinical Research in accordance with the ICH Guideline for Good Clinical Practice: Consolidated Guidance (E6).
Principal Investigator Oversight Informational Program
Informational program outlining the basic components related to Principal Investigator oversight of clinical trials
Principal Investigator Oversight Informational Program Guidance
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
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