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Site Qualification and Training Solutions

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.

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.

EDC System Training Mutual Recognition

In 2016, SQT developed a process to enable a voluntary mutual recognition of Electronic Data Capture (EDC) system training across companies. This addressed a pain point in the industry at that time by allowing previously completed EDC system training taken by investigator site personnel and monitors to be recognized by other companies, making it unnecessary to re-train separately for each company. Based on an evaluation performed by the SQT team in 2019, it was determined that the industry has evolved to address this gap that previously existed. Therefore, the decision was made to retire the EDC program.

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 clicking the link.)

Nothing in these documents or forms should be construed to represent or warrant that persons using these documents or forms have complied with all applicable laws and regulations. All individuals and organizations using these documents or forms bear responsibility for complying with the applicable laws and regulations for the relevant jurisdiction.

  • One form for sites and Member Companies to use
  • A consistent definition of the tasks
  • Less risk for errors
Form DocumentsWhat Is It?Value of UsingRelated 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.One form for sites and Member Companies to use

A consistent definition of the tasks

Less risk for errors
FIDS Guidance

FIDS Summary of Changes
Protocol Level Informed Consent Tracking Log  

Site-Specific 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.Transparency to the protocol and site-level changes to inform sites, Member Companies and auditors

Enable more robust discussion with patients during re-consent 
Protocol and Site Level Informed Consent Logs Guidance
Site Profile FormThis form was retired and replaced with the Facility Profile Form. If you have previously completed any version of the Site Profile Form template, it is recommended you complete and begin using the current version of the Facility Profile Form, which is compatible for future integration with the Shared Investigator Platform.  Please read the Facility Profile Form Guidance Document and FAQ below for all pertinent information. 
Facility Profile Form A questionnaire for collecting site capability information (an off-line version of form inside Shared Investigator Platform)Reduce the burden on sites by collecting information in a consistent way across multiple sponsor companiesFacility Profile Form Guidance Document

Facility Profile Form FAQ
Curriculum Vitae (CV) Template (Word)

Curriculum Vitae (CV) Template (PDF)  
A template for Curriculum Vitae (CV).One consistent approach for all sites and member companies

Reduce confusion and administrative burden
CV Template Guidance

CV Template FAQs

CV Template Summary of Changes  
Site Signature and Delegation of Responsibilities LogOne delegation log for sites to use with consistently named tasks and clear instructions.One template for all sites and members to use with a consistent definition of the tasks

Reduce confusion and administrative burden for the sites

Improve the quality of the information
Site Signature and Delegation of Responsibilities Log Guidance

Site Signature Summary of Changes
Form FDA 1571 – Guidance for Completion

Form FDA 1572 – Guidance for Completion
Intends to assist sites with the interpretation of FDA’s 1571/1572 forms and guidance.Improve the process to collect and send the data

Less room for mistakes
N/A

Informational Program for Investigator Sites

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. To view these modules, please visit the SCRS website here. 

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