Site Management Modules - Society for Clinical Research Sites – SCRS
Site Management Modules

Site Management Modules

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).
Title Description Details
Principal Investigator Oversight Informational Program  Values
• Enhanced patient safety and quality of clinical trial oversight
• More effective and efficient study and site staff management by investigator
• Stronger relationship/partnership between site/sponsor

English | Mandarin
Informational program outlining the basic components related to Principal Investigator oversight of clinical trials Related Document:
Principal Investigator Oversight Informational Program Guidance
Adverse Events and Safety  Values
Improved understanding of Adverse Event identification and reporting by Investigators and their staff working directly with study subjects, as well as enhanced subject 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  Values
By understanding the phases and designs of a study, the Investigator is able to select the right study for his/her site.

English | Mandarin
Introduces and describes the phases of a Clinical Research Study and the various study designs. Run Time: 40 minutes
Clinical Practice vs Clinical Research  Values
Provides a deeper understanding of the differences between Clinical Practice and Clinical Research and what is involved in becoming a Clinical Researcher.

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  Values
Being able to describe and distinguish the different stages during the conduct of a study, and the tasks and activities associated with them, is instrumental for the successful conduct of the study as you can prepare and plan accordingly. A successfully conducted study helps collect high quality, reliable data and ensures that the rights, safety, and welfare of the subjects are protected.

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  Values
Prepares the Investigator and study staff for the interactions and activities required to obtain approvals necessary to conduct clinical research studies. Provides the Investigator and staff with the elements and requirements necessary to ensure that informed consent will be obtained and documented in accordance with the ICH-GCP.

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  Values
Clarifies the expectations for Investigator oversight of the study. By delegating tasks to appropriately qualified and trained individuals, this will enhance patient safety and the quality of the data collected for a clinical study.

English | Mandarin
An overview of study task delegation and the importance of providing/documents study training for site staff. Run Time: 20 minutes
Source Documentation  Values
Familiarizes the Investigator and site staff with the expectations and requirements for quality documentation during clinical trials to comply with ICH-GCP requirements.

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
Investigational Product  Values
This topic provides a guidance for ensuring quality handling in every step of the IP management process. The correct implementation of these processes will ensure the integrity of the IP and reducing risk to subject safety and data integrity.

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  Values
Enhanced regulatory compliance by understanding the requirements for preparing and maintaining essential documents.

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
Facilities and Equipment  Values
Facility, equipment and trained staff are all required to ensure study success and patient safety.

English | Mandarin
Describes the equipment and resourcing needs of a research center. Run Time: 20 minutes
Monitoring and Auditing  Values
By understanding the purpose and the routine activities of monitoring and auditing the Investigator and study staff will determine how they can prepare and plan for the time needed when conducting a Clinical Study.

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
Title Description Details
Site Signature & Delegation of Responsibility Log  Values
• One template for all sites and members to use with consistent definition of the tasks
• Reduce confusion and administrative burden for the sites
• Improve the quality of the information
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  Values
• Improve process to collect and send the data
• Less room for mistakes
Intends to assist sites with the interpretation of FDA’s 1571/1572 forms and guidance.  
Informed Consent Change Log (Site Specific)  Values
• Transparency to the protocol and site level changes to inform sites, member companies and auditors
• Enable more robust discussion with patients during re-consent
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