The Clinical Research Unit (CRU) at the Icahn School of Medicine at Mount Sinai contains a number of rules which must be followed during each study.
Policies and Procedures
Here are several steps which must take place at the beginning of each study:
- Notification—after approval of the application, you will receive a letter indicating that the study may commence when approved by the Program for the Protection of Human Subjects.
- Initial meeting with staff—we request that you contact Margaret Garrett-Herry, MSN, FNP, x. 41515, to arrange an initial meeting to review orders.
- Orders—orders, forms, and additional instructions must be filled out and adhered to.
- In-service—we ask that you attend an in-service. At the in-service, the study team meets with the CRU team to ensure that all of the elements are in place to safely and effectively begin the study. The research team investigator briefly presents an overview of the rationale, methods, and goals of the study; orders are reviewed; and any questions entertained. If there are specific materials to review (blood processing kits, etc.), these are also discussed during the in-service. The staff may request that an in-service be repeated if there are study changes or concerns.
- Yearly progress report—we require a yearly progress report.
There are a number of rules concerning subjects and the admission process which must be followed:
- A physician with admitting privileges must be a listed investigator and is responsible for the patient during his/her stay.
- Orders signed and dated by a physician listed on the protocol as a Prinicpal Investigator (PI) or co-investigator are required within 24 hours of admission. Please adhere to a list of Joint Commission on Accredication of Healthcare Organizations (JCAHO)-approved and unapproved abbreviations when completing this task. Fellows assuming this role must be listed as investigators and must have current IRB Education on the protection of Human Research Participants and HIPAA training Certificates.
- All Hospital and JCAHO regulations apply to CRU admissions. The admission note must be charted within 24 hours of admission. The admitting physician/designee must complete medication reconciliation forms on admission and prior to discharge. Additionally, the admitting physician must complete discharge summaries. Patient identification and procedure verification is required before invasive procedures.
- Subjects may go off premises if both the PI and the patient have signed and dated the proper form–Permission Sheet #14 for Off Premises Activities. However, we do not permit patients to leave the premises with an angiocatheter in place. Pediatric patients may use “The Zone” if the admitting physician has cleared them to do so.
- The Mount Sinai Health System Pharmacy must dispense all investigational drugs administered at the CRU. Inpatients who are currently taking prescription medications (except Schedule II drugs) should be encouraged to bring their medications in original labeled containers for pharmacy relabeling and administration by our nursing staff.
Policy for Review of Approved Studies When Changes Are Requested in Protocol, Resources, or Support
This policy streamlines processing of minor changes in approved protocols in order to expedite research. Any requests for changes in an approved protocol must be submitted in writing with Institutional Review Board (IRB) materials where relevant, with detailed explanations of the request and rationale. The Investigator should indicate rationale and relevance of the requested change with respect to the science, safety, and resources requested.
This request will undergo administrative review and triage by an Administrator, Medical Director and/or Assistant Director, RSAs as indicated, or Nurse Manager as indicated.
The Principle Investigator (PI) is responsible for all aspects of the study, and contact information must be available for 24-hour access to the PI or co-investigator with clinical responsibilities for the participant. The PI is also responsible for being familiar with the procedures of the CRU and ensuring co-investigators and coordinators are also familiar with these procedures and policies. The Introduction to the Clinical Research Centers and Research Unit provides an overview with information specific to coordinators and investigators undertaking a study at the CRU (e.g., policies/procedures, MD orders, and scheduling).
Below is a list of forms and guidelines to help you navigate and comply with established CRU and Icahn School of Medicine policies.
- Request for Admission
- CRU Generic Flow Sheet Template
- Sample Flow Sheet Template
- General Medical Clearance Orders Template
- Out Patient Order Template
- Serial Specimen Sampling and Processing Flow Sheet Template
- Serial Specimen Sampling and Processing Orders Template
- Patient History Template
Do’s and Don’ts:
- Remove the word “TEMPLATE” from example template when finalizing the orders.
- Signed consent and HIPAA forms are confirmed on the study participant’s first visit only.
- Unless a protocol requires it, height does not need to be requested at every visit.
- Flow sheets must coincide with MD orders.
- Only a medical doctor is permitted to sign MD orders.
- MD orders must be signed and dated for the date of the appointment, not the date it was signed.
- When ordering drugs, please indicate the following: name of drug, dose, route, & frequency.
- Please stipulate how the drug will get to the unit. Who will order (CRU staff or study team? How will it get to the unit (picked up by study team or CRU staff)?
- Research Pharmacist Ivy Cohen MUST be contacted prior to scheduling study participants receiving investigational drugs.
- Outpatients do not need an MD order to “admit” to CRU.
- All MD orders pertaining to lab test requests must be specific. Do not simply state “Hematology,” “chemistry,” or “electrolytes;” rather, indicate the specific test or panel.
- Refer to our Mount Sinai Hospital lab requisition form for the appropriate test as it pertains to your study.
- Be sure to supply the names and contact numbers pertinent to your study.