Study Coordinator Information

Prior to Protocol Submission

As study coordinator, you probably have a great deal of responsibility for the successful start-up, operation and completion of a research study. We can help you to become familiar with the details of running a Pediatric CTRC protocol in several ways. You can start by reading the materials on this Web site, especially on Protocol Submission and Running Your Protocol (buttons on the left), to learn about our procedures, timelines, and compliance requirements. The more familiar you are with how we operate, the easier it will be to get things done quickly and efficiently. If you will be involved with protocol preparation, then you can help the PI to understand how to fill out our electronic protocol application form, and to call the people listed on the form if you have questions. We are here to assist you in doing good science in an efficient manner.
In particular you should be aware that there are three required sign-offs prior to submitting any protocol. You must contact and get basic approval from Biostatistics, the Research Subject Advocate, and the Informatics Manager prior to your protocol even being reviewed for scientific merit. Members of these three staff areas will be sure that your study is designed properly and that we are able to meet your needs while complying with all appropriate rules and regulations. After you receive these OKs, the study will be forwarded to medical reviewers to evaluate it for scientific merit. Your protocol will then be scheduled for review at the next available Scientific Advisory Committee meeting. Typically, you need to submit your application one month prior to the next available review date to be place on the agenda for consideration.
COMIRB submission can be made at the same time you are applying to the Pediatric CTRC for approval, since you will need sign-offs from both groups before you can begin. See more information on COMIRB by following the link above.

During Protocol Submission

It is up to your PI if you will attend the SAC review meeting to discuss your protocol application. Typically these reviews are scheduled for 15 minutes each once every month, and are held on the 6th floor of Children's Hospital. Once the review is completed, the PI is excused and the SAC discusses whether or not to approve the study. The PI will be notified promptly of the SAC decision. If the study is not approved, there will typically be an explanation why not, and how to improve the submission for future changes and possible re-submission.

After Protocol Approval - Before Study Start-Up

Approved protocols will receive a CTRC number. Written approval (via email) will be sent to the PI with this number which authorizes their approval and ability to begin enrolling study subjects. It is a good idea during this time immediately after approval but before actual start-up for the study coordinator to contact the appropriate GCRC staff members to discuss final preparations for how the study will be run, contact information, and timing on any subject visits. Generally this will be done with the manager of the inpatient or outpatient nursing units, the Core Laboratory (if tests are required), and possibly with the Bionutrition unit if they are involved. Contact information for all of these groups and individuals can be found on this Web site under Groups & Services or Staff Directory (buttons on the left).

Study Start-Up

Follow your study design as approved as closely as possible. Sometimes you may encounter a need to make minor adjustments to accomodate study subjects or our staff's needs. As long as you are able to comply with your study design as approved, then we can make these adjustments as necessary. If you need to do anything that makes a change in how your study was originally approved, you will need to submit a Change Request Form to document this to our administration. See the section on this Web site on Running Your Protocol for more information. Or if you are not sure, call our administrative manager or RSA to discuss the situation and they will advise you how best to proceed.

Running the Study

Follow your study design as approved, enrolling the number of study subjects that were authorized . Collect your data as approved, being sure to protect study subjects' privacy so that individually identifiable information is not disclosed to unauthorized individuals who are not listed in your HIPAA authorization (where appropriate).

Handling Adverse Events/Serious Adverse Events

Even under the best circumstances, unplanned events can unfold that adversely impact the study or subject safety. We have specific definitions for these occurrences (AE/SAE), and require specific steps to be taken within time windows as defined in your protocol. In virtually all cases, you should immediately contact our Research Subject Advocate to inform them of the situation and confirm your plans for action and reporting.

About Enrollment Suspension/Stopping a Study

You are expected to follow your research study as designed and approved. Since our study population involves children, we pay especially close attention to any deviation from these procedures. We may require you to suspend enrollment temporarily while we investigate any irregularities or unplanned for events. If problems are found, or based on pre-determined criteria that were part of the original protocol approval, the study may also be halted until a full investigation can be performed. It may or may not receive approval to continue and finish enrolling based on the circumstances. Where a study is approved given a known set of high-risk parameters, a periodic review of critical variables will be monitored by a Data Safety Monitoring Board.

Ending the Study

When a study finishes, data can be analyzed and prepared for reporting and/or publication. Be sure that the study data is kept archived for the prescribed period as required by Federal and State law. The GCRC maintains file servers on networks that can hold your data for you in a safe and secure manner over a long-term (i.e., data archiving). You should also be aware of the NIH requirements for sharing your study data with other interested parties when requested. Contact our RSA or Informatics Manager if you need assistance.

Publications & Presentation Attribution

It is very important that any presentation or publication made based on CTRC-sponsored research give credit to our Center. Be sure to always include a statement such as the following: "This research was supported by Grant Number RR00069, General Clinical Research Centers Program, National Center for Research Resources, National Institutes of Health." It is also very helpful for us if you would deposit a copy of your presentation, abstract or publication on file with our administrative manager for future reference. We may also invite you to be part of our annual poster session for CTRC-supported research. This is a very fun, low-stress way to share the current status of your research with others within our local UCD community.

Annual Reporting of Census Data

Finally, we are required every year to report on all of our research activities and to balance the budget to NIH/NCRR for our work. You may be asked to provide information in support of your study describing your status including number of subjects enrolled thus far, number of inpatient or outpatient visits held, number of tests performed, etc. Your prompt attention to our requests for this information is required and appreciated.