The following resources have been made available to simplify and enhance the clinical trial site qualification and training process.
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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.
An explanatory overview video of GCP Training Mutual Recognition:
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
Beginning in 2015, TransCelerate membership began to develop forms for Investigator Sites to be used by the R&D ecosystem. Several forms were created with a range of benefits. Today, these forms are governed by the TransCelerate community. If you have questions or feedback, please contact email@example.com.
Please note that select Forms and Guidance Documents are governed and updated by the Society for Clinical Research Sites (SCRS). You may be redirected to the SCRS website upon clicking the link. If you have feedback, please email SCRS at firstname.lastname@example.org.
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.
|Form Documents||What Is It?||Value of Using||Related 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 Summary of Changes
|Protocol Level Informed Consent Tracking Log |
Site-Specific Informed Consent Tracking Log (Governed by SCRS)
|Protocol and Site-Level Informed Consent Logs for Member Companies and sites to enable a more meaningful and well-informed consent dialogue with patients.|
The Site-Specific Informed Consent Tracking Log and the supporting guidance document are governed by the Society for Clinical Research Sites (SCRS). If you have feedback, please email SCRS at email@example.com.
|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 Form||This 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 (See Cognizant’s SIP website for the latest version of 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 companies||Facility 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 Log (Governed by SCRS)||One delegation log for sites to use with consistently named tasks and clear instructions. This log and supporting guidance documents are governed by the Society for Clinical Research Sites (SCRS). If you have feedback, please email SCRS at firstname.lastname@example.org.||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 (Governed by SCRS)|
Form FDA 1572 – Guidance for Completion (Governed by SCRS)
|Intends to assist sites with the interpretation of FDA’s 1571/1572 forms and guidance. These guidance documents are governed by the Society for Clinical Research Sites (SCRS). If you have feedback, please email SCRS at email@example.com.||Improve the process to collect and send the data|
Less room for mistakes
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. If you have feedback about these modules, please email SCRS at firstname.lastname@example.org.