Page 273 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-109 SOP Title: Medication Orders
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to outline the procedures to be followed when helping your principal investigator complete a physician’s order in EPIC for an investigational drug for a study.
2. INTRODUCTION
Advancing care is a collaborative effort of the sponsor, institution, and study team to systematically test the safety, efficacy, and therapeutic dose of an investigational product (IP). In effort to carry-out the clinical trial in a manner that allows for a therapeutic effect to be determined, the investigator, or study doctor, must oversee the management of the IP with the investigational drug services pharmacy including ordering the IP at the prescribed intervals defined in the protocol and according to the IP manual instructions.
3. SCOPE
This SOP applies to all clinical trials conducted at Children’s Medical Center and/or under the purview of Children’s Medical Center Research Administration. Only physicians, may order medications.
4. RESPONSIBILITIES
Ordering medications is a necessary step prior to fulfilling dosing at the study visits. Only physicians, may order medications. Additionally, it is important that an order for the study IP be built in EPIC and that the PI and study team know how to complete a medication order to fulfil the dosing on study visits. The study coordinator should be sure that the persons delegated to enter medication orders know how to access and complete the order.
Additionally, the study coordinator should ensure that there is a signed and dated, physician’s order for the medication order any time a medication order is to be entered in EPIC. It is important that the study coordinator ensures that proper documentation of drug administration is entered in the subject’s binder and medical record. Also, the study team must ensure that any contingent pieces of information, such as height and weight, needed to fill the medication order are collected, entered and documented accurately in the study binder and medical record.
The function of placing medication orders in EPIC must be clearly defined across the study team and recorded in the delegation of authority (DOA) log. The IDS pharmacy team will verify this delegation on the delegation log in VELOS before completing the order. Personnel placing a medication order or picking up IP must be delegated these tasks on the DOA log.
5. SPECIFIC PROCEDURE
Only physicians, may order medications in EPIC There are three types of orders for IP:
1. One time order
2. Order Sets
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