Clinical Research Process Updates & Information - June 2024
Stay informed with the latest updates in clinical research processes covering a broad range of topics such as investigator-initiated studies, compassionate use, budgeting procedures, and more. Effective changes in OSP's collaboration with CTO and HSD ensure streamlined processes and enhanced procedures. Get ready for upcoming publications and procedural adjustments.
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Presentation Transcript
Clinical Research Office of Research Web Update June, 2024 MRAM Carol Rhodes Office of Sponsored Programs
OSP Clinical Research Web Content > Broadened to cover clinical research in general > Updated in collaboration with HSD and Clinical Trial Office (CTO) > Addresses process changes but also new areas of interest > New content: Investigator-Initiated Clinical Studies (including Trials) List of Master Clinical Trial Agreements updated Compassionate Use/Emergency Care Information Abandoned trials and process steps Anticipated publication: by July 1st
Process Information > Information on CTO s intake: REDCap Survey Determines whether study goes through CTO s budgeting and billing process Determines if study entry into OnCore CTMS is required Provides the RG prefix that is a common identifier across systems when used in the eGC1 short title > IRB Review and Fee: Information on getting an advance Grant worktag > MODs for clinical trials: We reduced campus required questions Itemized breakdown of budget change no longer required: > Zero budget worksheet acceptable Workday and OnCore CTMS process explained - why zero dollar SAGE budget is fine Award Changes
Process Information, continued > CTO review/approval: On industry-sponsored clinical trial budgets On CTA amendments where the budget is changing by 10% or there are new anticipated charges > Effective July 1st, change in how OSP receives CTO Summary Review and PI approval of that budget: CTO sends its Summary Review with attachments to PI/dept PI/dept attaches to ASR or MOD: > PI approval reflected in PI s response to CTO; e-mail uploaded to ASR or MOD > CTO Billing Grid and Budget attachments > If this is not available or provided at the time the ASR or MOD is created, OSP will return before we approve the ASR/MOD.
CTO e-mail to PI/dept (example): We completed the review of your study: Study Long Title: Sponsor: eGC1#:A190576 Attached please see the final billing grid exported from OnCore and the final budget for your approval. PI approval is required for OSP to move forward with contract execution. Please respond to this email with your approval of both the Billing Grid and the Budget. CTO Billing Compliance
