The QSSG committee has been hard at work! Effective August 15th, there is a new SOP detailing the process to create and maintain the CCTO’s SOPs. The new SOP can be found here.
A new SOP entitled “Off-Site Storage of Research Records” has been released and is available on the CCTO website at http://med.stanford.edu/ccto/services/regulatory.html#sops_guidelines. The intention of this SOP is to ensure appropriate controls of research records that are in long-term storage whether on-site at Stanford or off-site at a storage vendor. The storage process is usually initiated after a study is completed but may be initiated during the conduct due to space limitations. This SOP should be reviewed with documentation of the review/training within each CRG.
CCTO is excited to announce that our new and refreshed Intake Service Request process via REDCap Intake Survey will be going live on Monday July 2, 2018. As of this date, any request that comes through the old mechanism (firstname.lastname@example.org) will be referred to this new REDCap Intake Survey.
This new system will include several new features as well as process improvements. This Intake Survey will offer more a responsive user interface as well as maintain the ability to request multiple services simultaneously and to attach multiple documents. This new CCTO Intake Survey process will assist cancer investigators with the following activities:
- Initial IRB Submissions and modifications/amendments
- Initial IND/IDE Submissions and amendments
- Budget development and amendments for industry sponsored studies
- Scientific Review Committee (SRC) reviews
- Study record creation in OnCore
We hope you find the new Intake process to be more efficient with a fresh look, and easy to access information. With the new simplified process, the system automatically guides your request through the completion of the required steps based on the type of services is selected.
The new REDCap Survey is accessible by clicking on the CCTO Intake Survey icon on CCTO’s Service Request page or accessing the survey directly at https://redcap.stanford.edu/webauth/surveys/?s=REJM9YA7NX
User documentation is located on CCTO’s service request page. In addition, user education sessions will be scheduled in future. CCTO will provide updates on requests and will solicit feedback on this new process through REDCap.
If you have any questions, please contact the CCTO Intake Coordinator at email@example.com.
RMG/CCTO has developed a new workflow process for use of PHI for complex procedure pricing to ensure minimum necessary access to PHI. The new documents can be found at Coordinator Corner:
- Complex Procedure Pricing Workflow
- Complex Procedure Pricing Information
- Process for Requesting Hospital Billing Information
In order to approximate a reasonable estimate of hospital charges for a complex procedure, RMG/CCTO requires the assistance of the study team and Patient Financial Services (PFS) to identify previous examples upon which we can develop a reasonable estimate. This is an operational business need.
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As of April 23, 2018, clinical staff will no longer need to submit an OnCore Update Request form for either staff updates or staff access to the team’s protocols in OnCore. All updates to the staff listing in OnCore can be made directly in the system by your Clinical Research Manager. Please contact your clinical research manager if you need any changes to accessing protocols managed by your team in OnCore.
If your research manager is unavailable or you are working with a team that uses OnCore for oncology protocols but does not report directly to the CCTO, please send your staff update request directly to OnCore team at firstname.lastname@example.org and we will process these for you. The OnCore Update Request form has been modified to reflect this change.