STEPS TO STUDY ACTIVATION
Hospital-based or Inpatient Research Considerations
For studies involving participants admitted as inpatients at an Indiana University Health (IUH) facility, additional considerations are required. This guidance is applicable in the following scenarios:
- Studies enrolling or treating participants in inpatient units within an IUH facility.
- Studies enrolling or treating participants in diagnostic or interventional areas within a hospital setting, such as the operating room, cardiac catheterization lab, radiology, etc., where the study participants are inpatients at the time of enrollment or treatment.
- Interventional studies enrolling or treating participants in any inpatient area, in the emergency department regardless of inpatient status, and in diagnostic, radiology, or operating room areas involving inpatients.
- Interventional studies with investigational products (e.g., drugs, biologics, FDA-approved drugs for new indications) must use Investigational Drug Services (IDS). For studies involving standard of care medications, IDS may not be required, but they should make that decision. For more information, visit Submit to Investigational Drug Services.
- Interventional studies involving an investigational device must follow IU Health specific processes, which can be found on the Requirements for Device, Equipment and Software in Research page.
- A Cerner research order set is necessary for any interventional inpatient studies involving investigational products, as required by the Joint Commission. The Cerner Research Order Set request form is located on the IU Health Access page of the OCR website. For assistance, you may also email ISClinicalResearchSupport@iuhealth.org. For oncology studies, please refer to the section below on IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information.
- Cell therapy and immune effector cell studies (such as CAR T-cell, TIL, TCR, NK therapies, etc.) are currently conducted only at downtown IU Health locations, including University Hospital, IU Simon Comprehensive Cancer Center, and Riley Hospital.
- Additionally, these types of trials require a Cerner order set. The order set is reviewed by the IDS pharmacy team, and the oversight of the investigational product will most likely be managed by IU Health’s Cellular Therapy Lab (CTL).
- Please note that all Cell Therapy and Immune Effector Cell studies require an additional review by the Cell Therapy Pipeline Committee. Please see Cellular Therapy & Immune Effector Cell Trials for more information.
Indiana University Health’s Enterprise Clinical Research Operations (ECRO) specializes in inpatient research. The ECRO team provides 24/7 on-call coverage and is primarily made up of registered nurses with a critical-care background. ECRO can provide full support for clinical trials including contract/budget preparation, regulatory preparation and management, recruitment, and all subject-related tasks.
For more information about ECRO please email clinicalresearchsupport@iuhealth.org to connect with someone from the team.
It is important to identify and engage with nursing leadership and support staff within the inpatient areas where study teams will interact with patients. This is especially important when study-related tasks and procedures may impact the patient’s clinical care. Identify and communicate with these people early in the start-up process, ideally during the feasibility process.
- Discuss investigator and coordinator availability for after hours and weekend coverage. Determine how the investigator will be contacted and whose responsibility it will be to contact the investigator/research team should a need arise. Communicate early and often with the service line who will oversee the participants in-hospital care.
- Nursing leadership in these areas can help identify and direct education needs and often can offer insight about workflow and unit policies that may affect the research team’s success in the trial.
- Ensure that if a participant will need to be admitted as inpatient specifically for research, you identify the correct person within the applicable department of medicine/clinic to coordinate securing a bed via bed control.
- Although order set creation is required for interventional studies involving investigational products, it can also be useful for non-interventional studies using IU Health billable services (such as lab or radiology) to streamline the ordering process. For more information, see the link in the “Interventional Studies” section above.
IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information
For Cancer Center Trials (studies involving cancer patients):
For Cancer Center studies, contact IDS to be added to the Cancer Center order set SharePoint. This will provide access to the order set templates and communication process used for Cancer Center studies.
Other Considerations
If your study involves the use of cellular therapy or immune effector cell investigational products (such as CAR T-cell, TIL, TCR, NK therapies, etc.), then please review the Cellular Therapy and Immune Effector Cell Trials page for additional requirements and needed approvals.
For questions related to the inpatient research workflow please contact clinicalresearchsupport@iuhealth.org
Assessing your study’s hospital-based or inpatient research requirements is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.