Investigational Drug Services Certificate

The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This activity is intended for pharmacists and pharmacy technicians who would like to grow their knowledge and skills in investigational drug services.

Introduction to Clinical Research
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• Apply the definition of clinical research to a proposed research project.
• Choose the appropriate ethical principle, as outlined in the Belmont report, as it pertains to a specific aspect of clinical research.
• Identify the FDA regulation for different aspects of the drug approval process.
• Differentiate the roles of agencies or organizations that have oversight over clinical research involving drugs.
• Interpret relevant regulations or guidelines concerning the role of investigational drug services in clinical research. 

Types of Clinical Trials
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• Differentiate between types of interventional and non-interventional clinical trials.
• Select the components of clinical trial phases that make them distinctive.
• Analyze published medical literature for types of bias to determine the effects on study outcomes.
• Recommend clinical trial designs for special patient populations.
• Summarize the role of data and safety monitoring.
• Choose a pathway by which a drug or vaccine may become authorized for use by the public in the United States. 

Clinical Trial Operations: The IDS Perspective
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• Identify the elements of a clinical trial protocol needed by IDS to operationalize a study.
• Interpret the titles and roles of study personnel at the sponsor and site levels.
• Differentiate the responsibilities of IDS pharmacists and technicians.
• Recommend ways to assign study-personnel responsibilities in a blinded clinical trial.
• Select the appropriate training and qualifications needed by IDS staff.
• Summarize the different practice and investigational product distribution models that exist in IDS. 

Clinical Trial Start Up for IDS
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• Summarize the lifecycle of a clinical trial protocol.
• Describe the institutional and operational review/approval process for a clinical protocol startup.
• Identify the feasibility assessment and physical requirements for IDS pharmacy.
• Recommend a process and strategy for developing an IDS Pharmacy fee schedule for research protocols.
• Discuss the maintenance of essential and relevant IDS documentation for a clinical trial. 

Clinical Trial Start Up for IDS: Applying Your Knowledge
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• Use a pharmacy feasibility form for a protocol based on your institutional capabilities.
• Calculate a pharmacy budget for a protocol utilizing a sample IDS Fee Schedule.
• Construct a standardized investigational drug product physician order/prescription template for oral and intravenous investigational drugs.
• Develop sections of the in-service sheet and compounding instructions based on a protocol and pharmacy manual.
• Use a Drug and Device Accountability Record (DAR) to record a drug receipt for an investigational drug product shipment. 

Medication Management for IDS
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• Describe the relationship and authority for a pharmacist working within a protocol for investigational medication management.
• Select the necessary documentation for receiving study medication.
• Differentiate the necessary steps for managing temperature excursions.
• Choose the appropriate accountability form and the required information for that form.
• Assess the importance of interactive response technology (IRT) systems within the accountability and dispensing process.
• Differentiate the necessary steps for transporting investigational product.
• Summarize methods to document chain of custody.
• Summarize investigational product labeling methods for controlling the study blinding. 

IDS Quality Management: Monitoring Visits and Audits
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• Select the appropriate pharmacy source documentation and training that may be required in the conduct of clinical trials.
• Evaluate how protocol deviations can be addressed.
• Differentiate between a clinical trial monitoring visit and clinical trial audit.
• Recommend how to prepare for a monitoring visit.
• Identify the purpose of a clinical trial audit.
• Assess how to plan and prepare for an audit. 

Medication and Quality Management for IDS: Applying Your Knowledge
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• Assess laboratory parameters and prohibited medications based on eligibility requirements from a protocol.
• Recommend dosing for investigational drug(s) based on a patient’s current medical information and a protocol.
• Use the Drug and Device Accountability Record (DAR) for dispensing a mock investigational drug.
• Given a monitor visit case, develop a workflow to manage visit requirements.
• Summarize trends for the future of investigational drug services.

Hallie Barr, PharmD, BCOP
Pharmacy Manager, Investigational Drug Service
The Ohio State University Wexner Center and James Cancer Hospital
Columbus, Ohio 

Sebastian Biglione, PharmD, PhD, MLA, BS, RPh, CCRP
Research Pharmacist
The Ohio State University Wexner Center and James Cancer Hospital
Columbus, Ohio 

J. Michael Hayes, PharmD, CPh
Pharmacotherapy Specialist, Investigational Drug Service
Tampa General Hospital
Tampa, Florida 

Ryan Janeway, PharmD, BCOP
IDS Clinical Pharmacist Specialist
Moffitt Cancer Center
Tampa, Florida 

Jordan Johns, RPhT, CPhT
Pharmacy Technician Specialist, IDS Pharmacy
Moffitt Cancer Center
Tampa, Florida 

Joyce S. Lee, PharmD, BCOP, BCPS
Senior Pharmacist, Investigational Drug Service/Oncology
UC Davis Medical Center
Sacramento, California 

Anay Moscu, PharmD, BCPS, BCOP, ACRP-CP
Investigational Drug Services Pharmacy Manager
Moffitt Cancer Center
Tampa, Florida 

Janelle Perkins, PharmD, BCOP
Professor
University of South Florida Taneja College of Pharmacy
Tampa, Florida 

Anu Pradhan, RPh, PhD, BCOP
Investigational Drug Service Supervisor
Moffitt Cancer Center
Tampa, Florida

In accordance with our accreditor’s Standards of Integrity and Independence in Accredited Continuing Education, ASHP requires that all individuals in control of content disclose all financial relationships with ineligible companies. An individual has a relevant financial relationship if they have had a financial relationship with ineligible company in any dollar amount in the past 24 months and the educational content that the individual controls is related to the business lines or products of the ineligible company.

An ineligible company is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The presence or absence of relevant financial relationships will be disclosed to the activity audience.

No one in control of the content of this activity has a relevant financial relationship (RFR) with an ineligible company.

As defined by the Standards of Integrity and Independence definition of ineligible company. All relevant financial relationships have been mitigated prior to the CPE activity.

This online activity consists of a combined total of 8 learning modules. Pharmacists are eligible to receive a total of 20.5 hours of continuing education credit by completing all 8 modules within this certificate.

Participants must participate in the entire activity, complete the evaluation and all required components to claim continuing pharmacy education credit online at ASHP Learning Center. Follow the prompts to claim credit and view your statement of credit within 60 days of completing the activity.

Important Note – ACPE 60 Day Deadline:

Per ACPE requirements, CPE credit must be claimed within 60 days of being earned. To verify that you have completed the required steps and to ensure your credits have been reported to CPE Monitor, check your NABP eProfile account to validate that your credits were transferred successfully before the ACPE 60-day deadline.   After the 60 day deadline, ASHP will no longer be able to award credit for this activity.