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.
• Orders—orders, forms, and additional instructions must be filled out and adhered to.
• In-service—we may 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.
• Approval—while applications are reviewed at the same time as IRB review, final approval is held until the IRB approval. Please submit a copy of the IRB approval letter and the dated consent form.

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.
• Pediatric patients may use “The Zone” if the admitting physician has cleared them to do so.
• The Mount Sinai Health System Investigational Drug Service must dispense all investigational drugs administered at the CRU.

The Principal 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 PI will also ensure that the CRU is updated with any changes to study staffing in a timely manner. The CRU Investigator Orientation link provides an introduction to the Clinical Research Unit with information such as policies/procedures, MD orders, and scheduling; specific to coordinators and investigators undertaking a study at the CRU. The Introduction to the Clinical 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.

Administrative Forms

• Protocol Application Form
• CRU Fee Schedule

Study Forms

• ERAP Guide

Nursing Forms

• Sample Blood Draw MD Orders
• Sample Infusion MD Orders
• Sample Medical Clearance MD Orders

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 at 212-241-5227 for the appropriate test as it pertains to your study.
• Be sure to supply the names and contact numbers pertinent to your study.