Industry Initiated Studies
Start-up: Industry Initiated & Sponsored Studies
Want to get your industry study open to enrollment as fast as possible?
- Consider the timing of study team start-up activities.
- The chart below can be used as a guide for setting study team goals for activating a new study quickly.
- Contact SOMCT to schedule a pre-study meeting after you have completed an initial feasibility assessment and are prepared to expedite start-up activities: SOMCT@vcuhealth.org
Need additional resources or guidance for activating your Industry study quickly?
- Review the SOM Process and Workflow Guide for study teams to initiate concurrent budget and contract negotiation:
- Use the SOM Industry Study Planning Guidebook for detailed checklists for study activation and management.
- Review SOM Guidance on Clinical Research Budget development by clicking here (log-in required)
FAQs for Industry Start-Ups:
What documentation does SOMCT require and when?
Prior to the
SOM Pre-Study Meeting
Submit to SOMCT for:
Initial Budget & Congruency Review
Submit to SOMCT for:
Final Budget & Congruency Review
|Protocol||Coverage Analysis (signed by PI)||Negotiated Internal/Sponsor Budgets|
|Draft Informed Consent||Feasibility Assessment (signed by PI/Chair)||OSP negotiated CTA with final budget & payment edits|
|Study Schedule/Schema||Draft Budgets (Internal & Sponsor)||Signed Ancillary Agreements|
|Sponsor Budget Template||Budget Support - Ancillary/Time Grids||Approved Informed Consent|
|Clinical Trial Agreement (CTA)||Informed Consent - Injury Language Negotiated|
|Initial Feasibility Assessment||CTA (with any requested edits in "track changes")|
** RAMS-SPOT submission should contain all final and signed documentation associated with the study.
How long will it take SOMCT to draft my Coverage Analysis?
Initial coverage analysis documents will be sent to the study team as attachments to the meeting summary within 2 business days of the pre-study meeting.
Study teams are strongly encouraged to review and finalize the coverage analysis as soon as possible. If no updates are needed, return a PI signed copy to SOMCT@vcuhealth.org as soon as possible.
What is SOM evaluating at Initial and Final Review?
SOM is evaluating congruency between key study documents: coverage analysis & billing plan, informed consent, budget, and contract. SOM is also reviewing the study budget for financial adequacy. It is important to ensure cohesiveness between these study documents to ensure responsibility for study costs are clearly outlined to all parties involved in the study (sponsor, VCU, participants).
The initial review is conducted at the end of budget development. After the SOM Initial review is completed and feedback provided, departments may begin budget negotiation with the sponsor.
The final review is conducted at the point of finalizing a budget negotiation with a sponsor. After the SOM Final review is complete, the budget can be considered final with the sponsor and the submission can be routed through RAMS-SPOT for school and institutional approvals.
For more information: SOM Industry Study Activation Workflow Guide
How long will it take SOMCT to complete Initial and Final reviews?
Initial reviews will be sent to the study team within 5 business days of receipt.
Final reviews will be sent to the study team within 3 business days of receipt.
Any tips for study teams to be successful in fast tracking start-up of an industry sponsored study?
- Be organized and be ready. The study team must help drive the timeline. Multiple actions must be done concurrently (regulatory, budget, contract) to be successful in activating quickly (see chart above).
- Finalizekey activities as early as possible.
- The Coverage Analysis & Billing Plan are critical for downstream activities such as Informed Consent negotiation, budget development and contract negotiation.
- Budget Development: Ancillary pricing can take some time, start as early as possible.
- Short on time? Consider CRS resources for budget development/negotiation and IRB submissions. Contact: CRSAdmin@vcu.edu for more information.
For complete Clinical Research FAQs click here
Additional SOM Guidance: