Certified Investigational Drug Services Pharmacist (CIDSP)

CIDSP (IDS-001) Exam Objectives

This exam certifies that the candidate has the specialized regulatory and operational knowledge to manage an Investigational Drug Service pharmacy in compliance with all applicable standards.

Domain 1: Regulatory Compliance and Good Clinical Practice (GCP) (35%)

• Federal Regulations: Apply FDA regulations (e.g., 21 CFR Parts 50, 56, 312) and Office for Human Research Protections (OHRP) rules for protecting human subjects.
• Good Clinical Practice (GCP): Apply the principles of ICH-GCP (E6) to all aspects of investigational drug management.
• Institutional Review Board (IRB): Describe the role and function of the IRB and the pharmacist's role in the submission and approval process.

Domain 2: Clinical Trial Protocol Management (30%)

• Protocol Review and Feasibility: Conduct a feasibility review of a new clinical trial protocol from a pharmacy perspective, identifying potential operational challenges.
• Service Implementation: Develop all necessary operational procedures for a new study, including order set builds, dispensing procedures, and accountability records.
• Randomization and Blinding: Describe and implement different randomization and blinding schemes to maintain the integrity of a study.

Domain 3: Investigational Product Handling and Dispensing (25%)

• Procurement and Inventory: Manage the ordering, receipt, and temperature-controlled storage of investigational products.
• Drug Accountability: Maintain meticulous, audit-ready accountability records for every dosage unit from receipt to final disposition.
• Compounding and Preparation: Develop procedures for the safe and accurate compounding of sterile and non-sterile investigational products according to the protocol and USP standards.

Domain 4: Documentation and Auditing (10%)

• Essential Documents: Maintain all essential pharmacy-related documents for a clinical trial.
• Audit Preparedness: Prepare for and participate in monitoring visits and audits from study sponsors, CROs, and regulatory agencies like the FDA.

Eligibility Requirements

To be eligible to sit for a CPS certification exam, candidates must meet the criteria outlined in one of the two pathways below.

Pathway 1: For U.S. Licensed Pharmacists

This pathway is for pharmacists licensed to practice within the United States, regardless of country of graduation.

• Hold an active and unrestricted pharmacist license in any state or territory of the United States.
• Meet educational requirements by being a graduate of an ACPE-accredited school of pharmacy or holding a Foreign Pharmacy Graduate Examination Committee® (FPGEC) Certificate.
• Fulfill the specialty experience requirement as outlined below.

Pathway 2: For International Pharmacists (Non-U.S. Licensed)

This pathway is for pharmacists who practice outside of the United States.

• Hold an active and unrestricted license to practice pharmacy in their country of practice. A certified English translation of the license must be provided if the original is not in English.
• Hold a professional degree in pharmacy equivalent to a U.S. pharmacy degree, such as a Bachelor’s degree (BPharm), Master’s degree in Pharmacy Practice (MPharm), or Doctor of Pharmacy degree (PharmD).
• Fulfill the specialty experience requirement as outlined below.

Specialty Experience Requirement (for all pathways)

To ensure candidates have foundational knowledge in the specialty, one of the following criteria must be met:

• Standard Pathway:
  Completion of at least one year of professional experience in a practice setting directly related to the certification area.
• Certificate Pathway:
  The one-year specialty experience requirement is waived for candidates who hold an active certificate of completion from a nationally recognized provider in a related subject matter. This includes, but is not limited to, the completion of a relevant PGY residency, fellowship, certificate/training program, or a relevant graduate degree (e.g., a Master's degree in the specialty field). Recognized providers of certificate programs include, but are not limited to:
  • American Society of Health-System Pharmacists (ASHP)
  • American Pharmacists Association (APhA)
  • American College of Clinical Pharmacy (ACCP)
  • American Society of Consultant Pharmacists (ASCP)

Career Path for CIDSP Professionals

The CIDSP certification is for pharmacists who are key players in clinical research, typically working in academic medical centers, cancer centers, and other research-intensive institutions. This credential signifies a high level of expertise in a specialized, regulatory-focused area of pharmacy.

Target Candidates

• Health-system pharmacists working in or supporting an Investigational Drug Service.
• Pharmacists with a background in clinical research or oncology.
• Individuals seeking to transition from a general hospital role to a research-focused position.
• Pharmacy leaders responsible for research compliance and oversight.

Primary Job Roles:

• Investigational Drug Service (IDS) Pharmacist
• Clinical Research Pharmacist
• Manager or Director of Investigational Drug Services
• Research Compliance Officer

Career Advancement:

A CIDSP is positioned for leadership roles within the clinical research enterprise. They can advance to become the Director of an IDS for a large health system, take on roles in research administration and compliance, or work for pharmaceutical sponsors or Clinical Research Organizations (CROs) managing multi-site trials.

Study Resources

Prepare for your CIDSP exam with resources focused on the rigorous standards of clinical research pharmacy.