Informational Programs for Site Staff Conducting Clinical Research
In 2015, SQT 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.
Please complete the form below for access to Site Management Modules.
Principal Investigator Oversight Informational Program
Informational program outlining the basic components related to Principal Investigator oversight of clinical trials
Related Document:
Principal Investigator Oversight Informational Program Guidance
ICH E6 R2 Update Investigator Oversight
Adverse Events and Safety
Explains and defines an Adverse Event. Describes the Investigator’s role and responsibilities regarding Subject Safety and reporting requirements for Serious Adverse Events.
Run Time: 30 minutes
Clinical Research Overview
Introduces and describes the phases of a Clinical Research Study and the various study designs.
Run Time: 40 minutes
Related Document:
ICH E6 R2 Update Introduction
Clinical Practice vs Clinical Research
An overview of the differences between the activities which occur when managing patients during routine Clinical Practice versus the activities when you are managing subjects as part of a Clinical Research Study.
Run Time: 30 minutes
Conducting a Study
Explains the three stages of study conduct phases including the subject enrollment/recruitment period, the ongoing maintenance and the subject exit/completion phase including the tasks and activities associated with these stages.
Run Time: 30 minutes
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
Delegation and Training
An overview of study task delegation and the importance of providing/documents study training for site staff.
Run Time: 20 minutes
Related Document:
ICH E6 R2 Update Delegation and Training Module
Source Documentation
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
Related Document:
ICH E6 R2 Update Source Documentation
Investigational Product
Overview of the basics of Investigational Product management and use during a clinical trial. Topics include inventory and temperature control and recommendations for source documentation.
Run Time: 20 minutes
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
Related Document:
ICH E6 R2 Update Essential Documents for Clinical Study Module
Facilities and Equipment
Describes the equipment and resourcing needs of a research center.
Run Time: 20 minutes
Monitoring and Auditing
Describes the routine monitoring and auditing activities which occur during a clinical study. This topic includes information on the purpose, what to expect, and tips to prepare for these Sponsor activities.
Run Time: 25 minutes
Forms
Site Signature & Delegation of Responsibility Log
One delegation log for sites to use with consistent named tasks and clear instructions.
Related Document:
Site Signature and Delegation of Responsibilities Log Guidance
Guidance for FDA 1571 Form
Guidance for FDA 1572 Form
Guidance for FDA 1572 Form – Japanese
Intends to assist sites with the interpretation of FDA’s 1571/1572 forms and guidance.
Informed Consent Change Log (Site Specific)
Site Level Informed Consent Log for Member Companies and sites to enable a more meaningful and well informed consent dialogue with patients.
Related Document:
Site Level Informed Consent 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