Informational Programs for Site Staff Conducting Clinical Research
In 2015, a Site Qualification and Training (SQT) taskforce developed a series of video modules to outline the basic components related to Principal Investigator oversight of clinical trials and the foundational concepts of Clinical Research in accordance with the ICH Guideline for Good Clinical Practice. These modules allow site staff with less experience to become more familiar with conducting clinical research. Following the public release of these modules, TransCelerate partnered with the Society for Clinical Research Sites (SCRS) to promote and maintain modules. In 2020, TransCelerate transitioned ownership of the modules to SCRS for continued promotion and governance. Today, SCRS continues to share these modules with the public at no monetary cost.
For additional information or to provide direct feedback on the modules and forms, please contact: firstname.lastname@example.org
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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
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• 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