Site Qualification and Training
The following resources have been made available to simplify and enhance the clinical trial site qualification and training process.
For Assets available in additional languages, please click here.
EDC System Training Mutual Recognition
SQT has developed a process to enable a voluntary mutual recognition of EDC system training across Member Companies. This allows previously completed EDC system training taken by investigator site personnel and monitors to be recognized by other TransCelerate Member Companies, making it unnecessary to re-train separately for each participating company.
For additional information, please visit our EDC System Training Mutual Recognition page.
GCP Training Mutual Recognition
One of the first solutions delivered by SQT was a set of Minimum Criteria to enable a voluntary mutual recognition process of GCP training across Member Companies. This allows clinical trial investigators and other site personnel to complete GCP training which may be recognized by other TransCelerate Member Companies, making it unnecessary to train separately for each participating company.
For additional information, please click to our GCP Training Mutual Recognition page.
Forms for Investigator Sites
(Some of these Forms are maintained by the Society for Clinical Research Sites (SCRS). You may be redirected to the SCRS website upon click)
|Form Documents||What Is It?||Value of Using||Related Guidance Documents|
|Financial Disclosure Form (FIDS)||Form intended for use by Clinical Investigators to disclose their financial interests for the period of time he or she participated in the study and for one year following the end of his or her participation in the study (as required by the U.S. Code of Federal Regulations 21CFR54) to the Study Sponsor.||
|Protocol Level Informed Consent Tracking Log||Protocol and Site Level Informed Consent Logs for Member Companies and sites to enable a more meaningful and well informed consent dialogue with patients.||
||Protocol and Site Level Informed Consent Logs Guidance|
|Site Profile Form||A questionnaire, or “Site Profile Form,” for collecting site capability information.
This form is currently undergoing enhancements. If you need to use this in the next 30 days, please contact us at SQT@transceleratebiopharmainc.com.
||Site Profile Form Guidance
Site Profile Form FAQs
|Curriculum Vitae Template||A template for Curriculum Vitae (CV).
This form, as well as the associated materials, are currently undergoing enhancements. Please check back for an updated version in the near future.
||Curriculum Vitae (CV) Template Guidance|
|Site Signature and Delegation of Responsibilities Log||One delegation log for sites to use with consistent named tasks and clear instructions.||
||Site Signature and Delegation of Responsibilities Log Guidance|
|Form FDA 1571 – Guidance for Completion||Intends to assist sites with the interpretation of FDA’s 1571/1572 forms and guidance.||
Informational Program for Investigator Sites
(This Informational Program is maintained by the Society for Clinical Research Sites (SCRS). You will be redirected to the SCRS website upon click)
|Informational Program||What Is It?||Value of Using||Related Guidance Documents|
|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|
Informational Program for Site Staff Less Experienced in 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).
This program may be used in its entirety or in part:
- To supplement the information provided to less experienced Investigators and their staff by Member companies when starting a Clinical Study.
- As on-boarding information for less experienced site staff joining an Investigator during a Clinical Study.
- As a remediation tool in the event of noncompliance during the conduct of a Clinical Study.
- By less experienced Investigators and their staff to demonstrate awareness when being considered by a TransCelerate member company for participation in a Clinical Study.
Please read the Guidance for Use prior to reviewing the topic overviews below.
(These Informational Programs are maintained by the Society for Clinical Research Sites (SCRS). You will be redirected to the SCRS website upon click)
|Informational Programs||What Is It?||Value of Using||Run Time|
|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.||Provides a deeper understanding of the differences between Clinical Practice and Clinical Research and what is involved in becoming a Clinical Researcher.||30 minutes|
|Clinical Research Overview||Introduces and describes the phases of a Clinical Research Study and the various study designs.||By understanding the phases and designs of a study, the Investigator is able to select the right study for his/her site.||40 minutes|
|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.||Improved understanding of Adverse Event identification and reporting by Investigators and their staff working directly with study subjects, as well as enhanced subject safety.||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.||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.||30 minutes|
|IRB/IEC Responsibilities & 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.||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.||30 minutes|
|Delegation and Training||An overview of study task delegation and the importance of providing/documents study training for site staff.||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.||20 minutes
|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.||Familiarizes the Investigator and site staff with the expectations and requirements for quality documentation during clinical trials to comply with ICH-GCP requirements.||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.||Enhanced regulatory compliance by understanding the requirements for preparing and maintaining essential documents.||20 minutes|
|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.||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.||20 minutes|
|Facilities and Equipment||Describes the equipment and resourcing needs of a research center.||Facility, equipment and trained staff are all required to ensure study success and patient safety.||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.||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.||25 minutes|
*The following are preferred settings to view the Informational Programs:
- Primary and secondary browser combinations : IE9+, Chrome 40+Safari 7, Firefox 17+
- Primary and secondary OS: Windows 8.8 and for Mac OSX10+
- 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