You have previously subscribed or have demonstrated interest in staying connected with TransCelerate.
TransCelerate has introduced 11 Informational Programs to provide less experienced principal investigators, sub investigators, site managers, study and regulatory coordinators with educational content at the start and during the conduct of a clinical research study, and used as a reference for remediation when necessary. These programs can be accessed through the TransCelerate website here. The TransCelerate SQT Initiative developed the Informational Programs to cover broad topics such as:
Responsibilities around adverse event reporting and informed consent
An overview of activities for IRB/IECs
Tips for monitoring and auditing
The SQT Initiative also announced the creation of an online framework to allow mutual recognition of completed, non-protocol specific EDC system training by multiple sponsors, reducing the trial burden on investigator site staff. This effort builds off the success of TransCelerate’s mutual recognition of Good Clinical Practice (GCP) training program.
With this framework available, if you are a sponsor or vendor that provides EDC system training, you can visit the TransCelerate website, submit an electronic confirmation form verifying details of your EDC system training, and provide a sample of the training providers certificate, if applicable. Sponsors can then elect to recognize your training rather than requiring investigators to retake EDC training.
For more information about the EDC system training framework, visit the FAQs page on the TransCelerate website.
To achieve its mission to reduce historical administrative burdens on the clinical trial site, the SQT Initiative has established minimum criteria for mutual recognition of GCP training, a self-attestation process for external GCP training providers, and common forms to collect generic site information. The SQT Initiative has now moved into an implementation / realization phase. To learn more, read our recent press release and read about our other active Initiatives.