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

English | Mandarin

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

English | Mandarin

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

English | Mandarin

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

English | Mandarin

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

English | Mandarin

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

English | Mandarin

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

English | Mandarin

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

English | Mandarin

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

English | Mandarin

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

English | Mandarin

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

English | Mandarin

Describes the equipment and resourcing needs of a research center.

Run Time: 20 minutes

Monitoring and Auditing

English | Mandarin

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