Protocol Submission Procedures
Who May Submit a Protocol
The VCU CRSU is available to all VCU Health System and VCU faculty members who want to conduct human subjects research. Student projects may be conducted but must be supervised by a faculty member who is the PI for the study. Medical or psychiatric responsible faculty must be identified if appropriate for the study. Clinical trials, inpatient visits, or prolonged outpatient visits must include at least one full-time faculty physician with admitting privileges who assumes overall participant responsibility.
Helpful Hints for Submitting
- In order to generate a budget for CRSU resources, the protocol needs to be submitted to Shirely Helm at shelm@mcvh-vcu.edu. This can be done early in the process prior to being ready to submit the study to the IRB or to the CRSU. Please be aware that changes in the protocol during the review process or because of modifications to the study may modify the budget.
- Please consider what portions of the study will be conducted by the CRSU (e.g.: will all visits be conducted on or by the CRSU?). Please submit this information with your study for budgeting. If you prefer, you can schedule an appointment with Doris Rice to review the protocol and/or study design.
- Protocols may be submitted to the IRB and CRSU either simultaneously or in any order. These committees review independently and may have different feedback for you. Research will not be initiated until approvals by both groups have been finalized.
- Once you are ready for the study to be reviewed by the CRSU, please submit the current documents to Shirely Helm at shelm@mcvh-vcu.edu. Reviews are conducted on the first and third Mondays of the month and your documents should be received at least 7 calendar days prior to the next meeting.
To Submit a Research Study to the CRSU
Documents must be submitted via e-mail.
Submission Content
Documents required for the review process include:
- Full length version of the protocol. If your protocol is only in the form of the IRB submission form and research plan this is acceptable. However, if there is also a full length version then this should be submitted.
- Informed Consent Form(s) (ICF)/ Parental or LAR permission and Assent(s) as applicable
- A Data and Safety Monitoring Plan or description of a monitoring board (helpful information is below)
- PI NIH Biosketch or CV (requested for first timeCRSU users)
- CRSU Submission Form. Fillable PDF available here.
Additional documents required by the CRSU for final approval include the following:
- Industry protocols- copy of the final budget or financial agreement with the sponsor
- Date-stamped and signed IRB/WIRB approvals of protocol and ICF
- Special required approvals such as IND or Radiation Safety Committee
- Pre-Study Planning Questionnaire. Fillable PDF available here.
Data and Safety Monitoring Plan
A Data and Safety Monitoring Plan (DSMP) is required of all protocols submitted to the Clinical Research Center (CRSU). Essential elements include:
- Indicate who will be responsible for data and safety monitoring during the study. (e.g. an external Data and Safety Monitoring Board, study team, or the PI only). In many cases, the PI/study team will perform much of the data and safety monitoring, with periodic review by the CRSU Audit Committee and by a Research Subject Advocate (RSA) who functions as an independent compliance officer.
- Indicate the content of the review (e.g. protocol compliance with inclusion/exclusion criteria, gender and minority, adverse events).
- Indicate the frequency of monitoring. A suggested strategy might be that each protocol will undergo its initial review by the study team after 10% of the anticipated enrollment or at least 3 subjects have been enrolled, with follow-up review at intervals to be dictated by protocol risk as determined by CRSU Scientific Advisory Committee. For low risk protocols, annual review may be adequate whereas high-risk protocols may require quarterly review.
- To whom are the results of the review reported? For the CRSU, it is suggested that reports be submitted to the CRSU Research Subject Advocate (RSA), Dr. Leo Dunn. The RSA is an independent compliance officer, as mandated by NIH, supporting research at the CRSU. Dr. Dunn may be reached at 827-0472 or at ldunn3@mcvh-vcu.edu.
Risk Assessment Anticipated and Unanticipated Adverse Events (AE)
- Provide a list of anticipated adverse events. In most cases these have been identified in the consent form. It may be helpful to identify those potential AE's which are of sufficient concern to include as study outcomes and warrant capture in the protocol database.
- Indicate the process by which anticipated AE's will be reported. Serious anticipated adverse events should be reported to the CRSU and may be reported to the IRB. Adverse events should also be retained in a study binder for review by the study team and the CRSU RSA.
- Indicate the process by which unanticipated AE's will be dealt with. It is assumed that all unanticipated AE's will be reported to the IRB as required by 45CFR46.103(b)(5)(i). This should include a grading and attribution scale and a mechanism for reporting these events to the IRB and CRSU. All serious unanticipated adverse events should be reported within 2 days to both the IRB and the CRSU (VCU IRB Prompt Reporting Form for Unanticipated Problems, http://www.research.vcu.edu/forms/vcuirb.htm).
Review Process
The CRSU review process will depend of whether the protocol has had a scientific review by the funding agency or other entities. General guide follows:
| Type of Protocol | CRSU Review Components |
|---|---|
| Industry funded that has been reviewed by FDA and WIRB |
|
| Federally funded protocol (e.g.: NIH, Department of Defense, etc.) |
|
| Foundation funded with a review that incorporates a scientific review (e.g.: American Heart Association, AD Williams) |
|
| Investigator initiated, pilot or feasibility studies, or foundation projects that have not had a scientific review |
|
- Full Approval.
- Conditional approval: The CRSU requests minor changes or clarifications that are required prior to Full Approval. The PI who accepts these changes or provides adequate clarification can be granted Full Approval. These changes and clarifications can be submitted to Shirely Helm at shelm@mcvh-vcu.edu.
- Tabled: The CRSU has raised major questions that must be addressed and satisfied. Most changes will be re-reviewed by the CRSU Scientific Advisory Committee. Please keep in mind these changes may require an amendment to the IRB.
- Rejected. The CRSU has determined that there are significant problems (scientific, ethical, or practical) that render the protocol unacceptable to be conducted with CRSU resources. PI’s may discuss the concerns and are welcome to resubmit with major changes.
Actions taken by the CRC are:
Required Steps Before a Participant Can Be Enrolled
- Budget and resource utilization reviewed and approved.
- Approval by the CRSU.
- WIRB or VCU IRB approval. Copies of the approval letter, informed consent(s) and assent(s) must be sent to Shirely Helm at shelm@mcvh-vcu.edu.
- All other required approvals in place (e.g. radiation safety, biohazards, drug handling plan).
- Pre Study Planning Questionnaire. The fillable quesionnaire should be completed prior to the inservice and submitted to Lou Usry at lusry@mcvh-vcu.edu.
- Inservice for CRSU staff.
- Participant Scheduling through Lou Usry, lusry@mcvh-vcu.edu or Yvonne Gotico, ygotico@mcvh-vcu.edu, 828-9101.
Procedure for Changes to a CRC Approved Protocol
After WIRB or VCU IRB has approved an amendment to the protocol it must be submitted to the CRSU. It is critical that the CRSU staff be working from the current protocol. If an amendment required changes to the consent or assent please be sure to provide these approved documents with the revised protocol to the CRC Shirely Helm at shelm@mcvh-vcu.edu.
If your resource request/needs change for an approved study, please contact Shirley Helm at shelm@mcvh-vcu.edu.
Submit IRB continuing review approval letters to Shirley Helm at shelm@mcvh-vcu.edu.